Anesthesiology
Review Panel
- CardiovascularReview Panel
- ChemistryReview Panel
- DentalReview Panel
- Ear, Nose, ThroatReview Panel
- Gastroenterology and UrologyReview Panel
- General HospitalReview Panel
- MiscellaneousMiscellaneous
- Subpart B—Cardiovascular Diagnostic DevicesCFR Sub-Part
- Subpart B—Diagnostic DevicesCFR Sub-Part
- Subpart C—Cardiovascular Monitoring DevicesCFR Sub-Part
- Subpart C—General Hospital and Personal Use Monitoring DevicesCFR Sub-Part
- Subpart D—Pathology Instrumentation and AccessoriesCFR Sub-Part
- Subpart D—Prosthetic DevicesCFR Sub-Part
- Subpart E—Surgical DevicesCFR Sub-Part
- Subpart F—General Hospital and Personal Use Therapeutic DevicesCFR Sub-Part
- BRZSet, Blood Transfusion2Product Code
- BWJLocator, Acupuncture Point2Product Code
- CAKMicrofilter, Blood Transfusion2Product Code
- DWLStocking, Medical Support (To Prevent Pooling Of Blood In Legs)2Product Code
- FMFSyringe, Piston2Product Code
- K243580GraftGun Universal Graft Delivery System (GDS)2Cleared 510(K)
- K242434Insulin Syringes2Cleared 510(K)
- K241856Sofjec (Single use Needle); Sofjec (Single use Syringe with or without Needle); Sofjec (Membrane Filter Syringe)2Cleared 510(K)
- K242099Sol-M™ Slip Tip Syringe without Needle, Sol-M™ Eccentric Tip Syringe without Needle2Cleared 510(K)
- K241821Luer Lock Syringe with Safety Needle; Luer Lock Syringe with Exchangeable Needle; Luer Lock Syringe with Blunt Fill Needle2Cleared 510(K)
- K231095Tamper Evident Cap2Cleared 510(K)
- K240961Disposable Pen Injector Assembly2Cleared 510(K)
- K241426GPS Advanced; 5 cc GPS Advanced Cannula2Cleared 510(K)
- K233368Allograft Delivery Device (OFAC-C)2Cleared 510(K)
- K240774Pen Injector2Cleared 510(K)
- K232950Sterile Disposable Syringe, Sterile Disposable Syringe with needle, Sterile Disposable Syringe with safety needle2Cleared 510(K)
- K234024HWJECT Auto-disable syringe2Cleared 510(K)
- K233794Insulin Syringe2Cleared 510(K)
- K230235Medline Luer Lock Syringes2Cleared 510(K)
- K231558SMB Luer lock disposable syringe2Cleared 510(K)
- K231877NavaClick Injection System2Cleared 510(K)
- K230061Insulin Syringe2Cleared 510(K)
- K231519Revital Cady2Cleared 510(K)
- K233056EpiZact2Cleared 510(K)
- K221777Disposable Sterile Syringe2Cleared 510(K)
- K231792VeriSafe Safety sterile syringes2Cleared 510(K)
- K231727Sterile Auto-Disable Syringes with/without Needle for Single Use2Cleared 510(K)
- K230447Sterile Syringe Bulk Tray2Cleared 510(K)
- K231900A-TAP (previously called Arthrotap)2Cleared 510(K)
- K222925Hypodermic Syringes & Needle2Cleared 510(K)
- K231456Avitus® DragonWing Large Volume Autograft Delivery System2Cleared 510(K)
- K230492Avitus® Precision Autograft Delivery System2Cleared 510(K)
- K212857Sterile Syringe for Single Use (with Needle), Sterile Hypodermic Needle for Single Use2Cleared 510(K)
- K220713Sol-Guard Auto-disable Syringe2Cleared 510(K)
- K221974EpiFinder2Cleared 510(K)
- K212207Sterile Hypodermic Syringe for Single Use2Cleared 510(K)
- K222672Disposable Insulin Syringe2Cleared 510(K)
- K223453Insulin Syringe2Cleared 510(K)
- K221702CompuFlo Epidural Computer Controlled Anesthesia System2Cleared 510(K)
- K212635Sofjec2Cleared 510(K)
- K223678Sterile Syringes for Single Use2Cleared 510(K)
- K203211Insulin syringe with integrated needle DL2Cleared 510(K)
- K213054Medline Sure-Snap Safety Needle, Medline Sure-Snap Safety Syringe2Cleared 510(K)
- K212764Medwell Technology Ltd Syringes, various sizes2Cleared 510(K)
- K221045Insulin Syringes without needle2Cleared 510(K)
- K221308Disposable Syringe with permanently attached needle, Safety Syringe with permanently attached needle2Cleared 510(K)
- K222744Sol-M Luer Lock Syringe2Cleared 510(K)
- K221079Sterile Hypodermic Syringes for Single Use2Cleared 510(K)
- K221068Sterile Hypodermic Syringes for Single Use with Needles2Cleared 510(K)
- K212846Sterile Hypodermic Syringe for Single Use, with/without Needle, Sterile Hypodermic Needle for Single Use2Cleared 510(K)
- K212033Disposable Sterile Syringe, with/without needle;luer/luer-lock, Disposable insulin syringe, Disposable Hypodermic needle2Cleared 510(K)
- K221737InstaFill Graft Delivery System, SIGNIFY Bioactive2Cleared 510(K)
- K220184Pump Alignment Syringe2Cleared 510(K)
- K213158Syringe with permanently attached needle2Cleared 510(K)
- K220204Disposabel Syringe with permanently attached needle, Safety Syringe with permanently attached needle2Cleared 510(K)
- K213811Sterile Hypodermic Syringes for Single Use2Cleared 510(K)
- K212677aboNT SYRINGE2Cleared 510(K)
- K213560Verifine Safety Syringe with Fixed Needle2Cleared 510(K)
- K203738Qitexio2Cleared 510(K)
- K212920Sterile Safety Syringe with Needle for Single Use, Sterile Safety Hypodermic Needle for Single Use,Sterile Auto-Disable Syringe with Needle for Single Use2Cleared 510(K)
- K212499BD Insulin Syringe (0.3mL)2Cleared 510(K)
- K210848Sure-Fine Insulin Syringes2Cleared 510(K)
- K213632Instylla Delivery Kit2Cleared 510(K)
- K211210Sterile Auto-Disable Syringes with/without Needle for Single Use2Cleared 510(K)
- K211482Disposable Syringe with Needle2Cleared 510(K)
- K201044CHIRANA Insulin Syringes2Cleared 510(K)
- K210914Sterile Syringe for Single Use2Cleared 510(K)
- K212544MiniLoad Syringe2Cleared 510(K)
- K211211Sterile syringes for single use with/without needle2Cleared 510(K)
- K211728Sterile hypodermic syringes for single use2Cleared 510(K)
- K210818TrueCare Biomedix Tamper Evident Cap2Cleared 510(K)
- K210227Sterile syringe for single use with/without needle2Cleared 510(K)
- K211242Promisemed Sterile Hypodermic Syringes, Verifine Sterile Hypodermic Syringes2Cleared 510(K)
- K210712Verifine Mechanical Safety Insulin Syringe2Cleared 510(K)
- K210997PreferX Delivery System2Cleared 510(K)
- K210991Disposable Sterile Syringe, Disposable Sterile Syringe with Needle2Cleared 510(K)
- K210464Auto Disable Syringe2Cleared 510(K)
- K203359BD Flu+ Syringe2Cleared 510(K)
- K210103SAFEWAY, LIFELONG PREMIUM, LIFELONG MATRIX2Cleared 510(K)
- K2102001 ml Sterile Hypodermic Syringe For Single Use. With/Without Needle. Luer/Luer-Lock2Cleared 510(K)
- K203264MicroDose Injector2Cleared 510(K)
- K202432MiniLoad Syringe2Cleared 510(K)
- K203453BD Hypodermic Syringe2Cleared 510(K)
- K201930Nanum Syringe2Cleared 510(K)
- K202544Instylla Delivery Kit2Cleared 510(K)
- K193273Insulin Syringe2Cleared 510(K)
- K192770S dispensing line2Cleared 510(K)
- K201284Sterile Hypodermic Syringe for Single Use, with/without needle, luer/luer-lock, Sterile Insulin Syringe for Single Use, with needle, Sterile Hypodermic needle for Single use2Cleared 510(K)
- K201816ARTHROTAP2Cleared 510(K)
- K2019003D GraftRasp System2Cleared 510(K)
- K193526Syringe with safety needle, Safety needle2Cleared 510(K)
- K201234BD SoloShot Mini Syringe/ BD Auto Disable Syringe2Cleared 510(K)
- K200325Orbit Subretinal Delivery System2Cleared 510(K)
- K201338Allograft MIS Delivery System2Cleared 510(K)
- K200629Aspire Mechanical Aspirator G2Cleared 510(K)
- K2004313D GraftRasp System2Cleared 510(K)
- K200606O-Genesis Graft Delivery System2Cleared 510(K)
- K193101Omnifix Low Dead Space Luer Lock Syringe2Cleared 510(K)
- K192674Mixing and Delivery System2Cleared 510(K)
- K193192Tamper Evident Cap2Cleared 510(K)
- K191642TK Sterile Piston Syringe without Needle2Cleared 510(K)
- K190054BD Insulin Syringe2Cleared 510(K)
- K191659Instylla Delivery Kit2Cleared 510(K)
- K191359Nipro Syringe2Cleared 510(K)
- K192421EpiFaith Syringe2Cleared 510(K)
- K190002Sterile Hypodermic Syringe for Single use, with/without needle, Sterile Insulin Syringe for Single use, with needle, Sterile Hypodermic needle for Single use2Cleared 510(K)
- K191531Sure-Fine Insulin Syringes2Cleared 510(K)
- K1827655cc Neuraxial Slip Tip Glass Syringe,5cc Neuraxial Lock Tip Glass Syringe,5cc Neuraxial Additive Slip Tip Glass Syringe,10cc Neuraxial Slip Tip Glass Syringe,10cc Neuraxial Lock Tip Glass Syringe2Cleared 510(K)
- K190996Bonus Therapeutics Mixing and Delivery System2Cleared 510(K)
- K190427Immucise2Cleared 510(K)
- K182268EpiFaith Syringe (Luer Slip) , EpiFaith Syringe (NRFit)2Cleared 510(K)
- K182589BD Plastipak Syringe2Cleared 510(K)
- K182387NovoPen Echo Dial-A-Dose Insulin Delivery Device (Pen Injector)2Cleared 510(K)
- K182274Orbit Subretinal Delivery System2Cleared 510(K)
- K182279Merit Syringe2Cleared 510(K)
- K182216Merit Syringe2Cleared 510(K)
- K172670BD Single Use, Hypodermic Syringe2Cleared 510(K)
- K180937Graftgun Universal Graft Delivery System2Cleared 510(K)
- K173029Nipro Syringe2Cleared 510(K)
- K173601Merit Syringe2Cleared 510(K)
- K173385Graft Delivery, DePuy Synthes2Cleared 510(K)
- K170900DASH 6 NRFit Lock Syringe + Accessories, DASH 6 NRFit Slip Syringe + Accessories, DASH 6 NRFit Plastic LOR Syringe + Accessories2Cleared 510(K)
- K171131MHC Standard and NRFit Tip Syringes2Cleared 510(K)
- K171805Luer-Jack Slip 3 ml, Luer-Jack Slip 5 ml, Luer-Jack Slip 20 ml, Luer-Jack Lock 10 ml2Cleared 510(K)
- K171362Merit Syringe2Cleared 510(K)
- K170675Graftgun Universal Graft Delivery System2Cleared 510(K)
- K161883CompuFlo Epidural Computer Controlled Anesthesia System2Cleared 510(K)
- K170386BD Ultra-Fine™ Insulin Syringe, BD Ultra-Fine™ II Insulin Syringe, BD Insulin Syringes with the BD Ultra-Fine™ needle and BD Insulin Syringes with Micro-Fine™ IV Needle2Cleared 510(K)
- K161812Freedom Syringe2Cleared 510(K)
- K163161Sterile Single-use Syringe with Needle2Cleared 510(K)
- K170218Vesco Medical NRFit Tip Syringes2Cleared 510(K)
- K161606Syringe with fixed needle - For use only with GONAL-F Multi-Dose 600 I/U mL FSH2Cleared 510(K)
- K162057ConceptoMed Luer-Jack Slip 10ml2Cleared 510(K)
- K162180Disposable Insulin Syringe2Cleared 510(K)
- K162081BD 1ml Luer-lok Hypodermic Syringe, BD 1 mL Luer-Lok Hypodermic Syringe with BD Hypodermic Needle or BD Eclipse Hypodermic Needle, BD 1ml Luer-lok Insulin Syringe2Cleared 510(K)
- K162602NovoPen Echo2Cleared 510(K)
- K161568Bone Solutions Mixing and Delivery System2Cleared 510(K)
- K152879Sure-Fine Insulin Syringes2Cleared 510(K)
- K160629InPen2Cleared 510(K)
- K152803SUNGSHIM STERILE SINGLE USE INSULIN SYRINGE2Cleared 510(K)
- K160978LITe BIO Delivery System2Cleared 510(K)
- K151870BD U-500 INSULIN SYRINGE2Cleared 510(K)
- K153537Sol-M Insulin Syringe, Sol-M TB Syringe2Cleared 510(K)
- K160668HumaPen Savvio2Cleared 510(K)
- K153553SiO2 Coated syringe 3 ml2Cleared 510(K)
- K151686HumanPen Ergo II2Cleared 510(K)
- K152783Merit 20 mL Syringe2Cleared 510(K)
- K151949Disposable Insulin Syringe2Cleared 510(K)
- K151777Intradermal Adapter2Cleared 510(K)
- K151766BD Single Use, Hypodermic Syringe2Cleared 510(K)
- K150874NovoPen Echo Dial-A-Dose Insulin Delivery Device (Pen Injector)2Cleared 510(K)
- K151543Graft Delivery Device with Integrated Stylet2Cleared 510(K)
- K150758Safety Disposable Insulin Syringe2Cleared 510(K)
- K142518HumaPen Luxura2Cleared 510(K)
- K142535ConMed Mixing and Delivery Kit2Cleared 510(K)
- K143757ANUTRA Feedback Aspiration Syringe2Cleared 510(K)
- K143488InFill Graft Delivery System2Cleared 510(K)
- K142661Bi-Portal Bone Graft Delivery Device2Cleared 510(K)
- K142636Merit 10mL Syringe2Cleared 510(K)
- K140710BIOMET GRAFT DELIVERY SYRINGES2Cleared 510(K)
- K141762PERFUSE PERCUTANEOUS DECOMPRESSION SYSTEM2Cleared 510(K)
- K141359HARD PACK SYRINGE2Cleared 510(K)
- K141245ETEX MIXING AND DELIVERY SYSTEM2Cleared 510(K)
- K140194NAMIC RCS SYRINGE2Cleared 510(K)
- K133493SINGLE USE STERILE SYRINGE WITH NEEDLE2Cleared 510(K)
- K132011APOTECA DUG COMPOUNDING DOSING DEVICE,APOTECA I.V. TRANSFER SET2Cleared 510(K)
- K132553U&U STERILE PISTON SYRINGE WITHOUT NEEDLE2Cleared 510(K)
- K132321JMS SYRINGE2Cleared 510(K)
- K133021MIXING SYRINGE SYSTEM2Cleared 510(K)
- K132120WTF SECURA SYRINGE AND NEEDLE2Cleared 510(K)
- K130230STERILE PISTON HYPODERMIC SYRINGES (WITH/WITHOUT NEEDLE), HYPODERMIC NEEDLES2Cleared 510(K)
- K131661INFUSION SYRINGE SET2Cleared 510(K)
- K131963TAUTONA INJECTOR DEVICE2Cleared 510(K)
- K124037JUNG RIM SINGLE USE HYPODERMIC SYRINGE WITH NEEDLE2Cleared 510(K)
- K131641MONOJECT 60ML SYRINGE (LUER LOCK TIP, LUER SLIP TIP, CATHETER TIP)2Cleared 510(K)
- K123766NOVOPEN ECHO, A DIAL A DOSE INSULIN DELIVERY PEN2Cleared 510(K)
- K130900EVICEL APPLICATION DEVICE2Cleared 510(K)
- K123710UNITOX BOTOX SYRINGE2Cleared 510(K)
- K122416ARTIGLASS L. O.R. GLASS SYRINGE2Cleared 510(K)
- K123588INTRADERMAL ADAPTER2Cleared 510(K)
- K130049MONOJECT 12ML SYRINGE2Cleared 510(K)
- K122787COMFORT EZ2Cleared 510(K)
- K122122REGEN SPRAY APPLICATOR,2Cleared 510(K)
- K122023MIXJECT WITH SPRAY HEAD2Cleared 510(K)
- K122373NEOMED ORAL/ENTERAL SYRINGE2Cleared 510(K)
- K121476INFILL GRAFT DELIVERY SYSTEM2Cleared 510(K)
- K113673MYSAFETY SYRINGE2Cleared 510(K)
- K121283BD EMERALD SAF-T SINGLE USE, HYPODERMIC2Cleared 510(K)
- K121124ARTHREX MIXING AND DELIVERY SYSTEM2Cleared 510(K)
- K111841SHIFENG DISPOSABLE SYRINGE WITH OR WITHOUT NEEDLE2Cleared 510(K)
- K112057KDL SYRINGES AND NEEDLE2Cleared 510(K)
- K113241BD EMERALD SINGLE USE, HYPODERMIC SYRINGE2Cleared 510(K)
- K112475XTRACT SYRINGE KEY SYSTEM2Cleared 510(K)
- K113091SYRINGES AND NEEDLES2Cleared 510(K)
- K110882IMC INSULIN SYRINGE2Cleared 510(K)
- K111632INFILL GRAFT DELIVERY SYSTEM2Cleared 510(K)
- K103830JIANGSU SHENLI MEDICAL PRODUCTION CO. LTD. PISTON SYRINGE (5CC LUER LOCK)2Cleared 510(K)
- K110697TIGER SYRINGES AND NEEDLES2Cleared 510(K)
- K111091MERIT MEDICAL 20 ML SYRINGE2Cleared 510(K)
- K103736DMC MEDICAL SINGLE-USE POLYCARBONATE SYRINGE2Cleared 510(K)
- K110771BD SINGLE USE, HYPODERMIC SYRINGE2Cleared 510(K)
- K110421DISPOSABLE INSULIN SYRINGE2Cleared 510(K)
- K110112CELL-TISSUE CONVERTER (CTC) SYRINGE WITH NEEDLE2Cleared 510(K)
- K103200PROPEP DELIVERY DEVICE2Cleared 510(K)
- K101708PATIENT SAFE LUER CAP2Cleared 510(K)
- K102192INDISCAL DIGITAL MANOMETER2Cleared 510(K)
- K102969IMC PISTON SYRINGES2Cleared 510(K)
- K101547HENKE- SASS, WOLF PISTON SYRINGE (NORM-JET)2Cleared 510(K)
- K102178EASY TOUCH2Cleared 510(K)
- K101359INVIROSTRIPE LUER LOCK SYRINGES (1, 3, 10, 20, 30 AND 60 ML)2Cleared 510(K)
- K100988HUMAPEN LUXURA HD2Cleared 510(K)
- K100665MARROMAX B ONE MARROW ASPIRATION NEEDLE KIT, MODELS 50083-XX, 50084-XX2Cleared 510(K)
- K100754GRAFT DELIVERY SYSTEM MODEL SA-61152Cleared 510(K)
- K093863EPIDRUM2Cleared 510(K)
- K0934001ML UNITRACT INSULIN SYRINGE 27G X 1/2 AND 29G X 1/22Cleared 510(K)
- K091722COAXIAL APPLICATOR SYSTEM2Cleared 510(K)
- K092908NEOMED STERILE SYRINGE, MODELS SD-S1EO, SD-S3EO, SD-S630, SD-S12EO, SD-S20EO, SD-S35EO, SD-S60EO2Cleared 510(K)
- K092986ACACIA PISTON SYRINGE2Cleared 510(K)
- K091200XTRACT SYRINGE KEYS2Cleared 510(K)
- K091279NIPRO DISPOSABLE SYRINGE2Cleared 510(K)
- K091167SHINA INSULIN SYRINGE-INCLUDING ACCU-SURE INSULIN SYRINGES2Cleared 510(K)
- K091474EASY.TOUCH INSULIN SYRINGE2Cleared 510(K)
- K091377BD FLU+ SYRINGE2Cleared 510(K)
- K083686BAIXIN DISPOSABLE SYRINGE, MULTIPLE SIZES2Cleared 510(K)
- K083583XPRESSE INJECTION SYSTEM2Cleared 510(K)
- K090929STERILE HYPODERMIC SYRINGE AND NEEDLE FOR SINGLE USE, STERILE INSULING SYRINGE FOR SINGLE USE WITH FIXED NEEDLE2Cleared 510(K)
- K091315COVIDIEN EXTENDED TIP APPLICATOR2Cleared 510(K)
- K083514TERUMO SYRINGE WITH/WITHOUT NEEDLE2Cleared 510(K)
- K090162EVICEL APPLICATION DEVICE2Cleared 510(K)
- K083457TACTIPEN2Cleared 510(K)
- K083193REVAC AUTO RETRACTABLE SAFETY SYRINGE2Cleared 510(K)
- K082674SPECTRA-GLASS LOR (LOSS OF RESISTANCE SYRINGE, 5CC METAL L/S OR L/L TIP, SPECTRA-GLASS LOR (LOSS OF RESISTANCE) SYRINGE2Cleared 510(K)
- K082454MICROMYST APPLICATOR, MODEL 20-50002Cleared 510(K)
- K081436INVIROSTRIPE 3ML, 5ML, 10ML LUER LOCK SYRINGES2Cleared 510(K)
- K082616HASELMEIER PEN 82Cleared 510(K)
- K081547BIO-MED SOFT INSULIN SYRINGE: MODELS 1CC, 0.5CC, 0.3CC2Cleared 510(K)
- K081241WEIGAO EMPTY CARTRIDGE SYRINGE2Cleared 510(K)
- K081524SPECTRA-LOR, 10 ML PLASTIC LOSS OF RESISTANCE SYRINGE, L/S, SPECTRA-LOR, 10ML PLASTIC LOSS OF RESISTANCE SYRINGE L/L2Cleared 510(K)
- K080989UNIVERSAL VIAL ACCESS SPIKE2Cleared 510(K)
- K072790CONFLUENT SURGICAL EXTENDED TIP APPLICATOR, MODEL 70-2008-0082Cleared 510(K)
- K072654PATIENT SAFE SYRINGE2Cleared 510(K)
- K072330CONTROLLED DELIVERY FOR OSTEOPLASTY (CDO SYSTEM) AND GRAFT PREPARATION SYSTEM2Cleared 510(K)
- K070856ICU MEDICAL SINGLE-USE SYRINGE2Cleared 510(K)
- K072299POWRSYRINGE ASPIRATOR2Cleared 510(K)
- K072345POWRSYRINGE MONITOR2Cleared 510(K)
- K072318POWRSYRINGE INJECTOR2Cleared 510(K)
- K062865SMALL VOLUME SYRINGE2Cleared 510(K)
- K071459B. BRAUN PISTON SYRINGES AND OMNICAN AND OMNIFIX INSULIN SYRINGES2Cleared 510(K)
- K071126CRYOSEAL FS APPLICATOR SYSTEM2Cleared 510(K)
- K071027TRIBOGLIDE LUBRICATED SILICONE-FREE SYRINGE2Cleared 510(K)
- K070936WELMED HYPODERMIC SYRINGE2Cleared 510(K)
- K071630TERUMO 31G THINPRO INSULIN SYRINGE2Cleared 510(K)
- K070917FEEL-JECT INSULIN SYRINGE2Cleared 510(K)
- K070633GENIE, MODEL CH-2002Cleared 510(K)
- K070814MODIFICATION TO CONFLUENT SURGICAL MICROMYST APPLICATOR AND AIR PUMP2Cleared 510(K)
- K070575EVICEL APPLICATION DEVICE2Cleared 510(K)
- K07026450 ML TERUMO SYRINGE FOR ADMINISTRATION OF UV SENSITIVE MEDICINES, MODEL BS-50LB2Cleared 510(K)
- K071108TEXIUM SYRINGE2Cleared 510(K)
- K070100HASELMEIER PEN2Cleared 510(K)
- K063348TOP FINE INSULIN SYRINGE2Cleared 510(K)
- K063535CAPTION APPLICATOR2Cleared 510(K)
- K062753FORSURE DISPOSABLE SYRINGE WITH NEEDLE, MODEL 1CC, 3C, 5CC, 10CC, 20CC, 50CC2Cleared 510(K)
- K063851AUTO-FILL SYRINGE KIT, MODEL 76002Cleared 510(K)
- K063613MODIFICATION TO TERUMO SYRINGE WITH/WITHOUT NEEDLE2Cleared 510(K)
- K062986MEDTRONIC GRAFT DELIVERY SYRINGE2Cleared 510(K)
- K062702ULTICARE DISPOSABLE SYRINGES AND NEEDLES2Cleared 510(K)
- K063280INJEKT SYRINGE2Cleared 510(K)
- K062260OSTEOBOOST-BMA2Cleared 510(K)
- K062365ARTHREX ASPIRATE KIT2Cleared 510(K)
- K061092BAXTER DUPLOSPRAY MIS APPLICATOR2Cleared 510(K)
- K062173MODIFICATION TO BONE GRAFT SYRINGE2Cleared 510(K)
- K061492MONOJECT MAGELLAN INSULIN AND TUBERCULIN SAFETY SYRINGE2Cleared 510(K)
- K061275MEDLINE SYRINGES, MULTIPLE2Cleared 510(K)
- K061039AMSURE DISPOSABLE SYRINGE WITH/WITHOUT NEEDLE2Cleared 510(K)
- K061183CONFLUENT SURGICAL DUAL LIQUID APPLICATOR, MODEL 70-2005-0932Cleared 510(K)
- K053563HUMAPEN MEMOIR2Cleared 510(K)
- K053413TERUMO SYRINGE FOR ADMINISTRATION OF UV SENSITIVE MEDICINES2Cleared 510(K)
- K060211WUZHOU SYRINGE, WITH/WITHOUT NEEDLE2Cleared 510(K)
- K060095MODIFICATION TO: VACLOK SYRINGE2Cleared 510(K)
- K052773B. BRAUN 0.2 MICRON FILTER2Cleared 510(K)
- K052667ARTSANA PISTON AND INSULIN SYRINGES2Cleared 510(K)
- K052075PROCEDUR-102Cleared 510(K)
- K052173VITAGEL SURGICAL HEMOSTAT SPRAY SET2Cleared 510(K)
- K052551DEVON STANDARD SYRINGE, HYPODERMIC NEEDLE AND INSULIN SYRINGE2Cleared 510(K)
- K050999YI XIN STERILE SYRINGE FOR SINGLE USE2Cleared 510(K)
- K051574NIPRO DISPOSABLE SYRINGE WITH OR WITHOUT NEEDLE2Cleared 510(K)
- K052034TERUMO SYRINGE WITH/WITHOUT NEEDLE2Cleared 510(K)
- K051930DRUG ACCESS SPIKE2Cleared 510(K)
- K051720SYNTHES (USA) BONE MARROW ASPIRATION SYRINGE2Cleared 510(K)
- K050998CONFLUENT SURGICAL MICROMYST APPLICATOR AND AIR PUMP, MODELS 20-5000, AP-A-60632Cleared 510(K)
- K050753STRYKER DISCMONITOR2Cleared 510(K)
- K050495EASYSPRAY AND SPRAY SET FOR TISSEEL (FIBER SEALANT)2Cleared 510(K)
- K043261HARVEST GRAFT DELIVERY SYRINGE2Cleared 510(K)
- K042500DUOPROSS SYRINGES2Cleared 510(K)
- K042486PROCEDUR 10 SYRINGE DEVICE2Cleared 510(K)
- K043172TRUGRAFT BGS SYRINGE, MODEL 600-0412Cleared 510(K)
- K042588CONFLUENT SURGICAL DUAL LIQUID APPLICATOR, MODEL 70-20050932Cleared 510(K)
- K042547DRAGON HEART PISTON SYRINGE2Cleared 510(K)
- K042314SYRINGE GRIP FOR THE AVONEX PRE-FILLED SYRINGE2Cleared 510(K)
- K0429341BD SOLOSHOT IX SYRINGE2Cleared 510(K)
- K033589BAXTER DUPLOTIP SURGICAL SEALANT APPLICATOR2Cleared 510(K)
- K041830MAGELLAN RATIO DISPENSER KIT2Cleared 510(K)
- K041991ASPIREX - BONE MARROW ASPIRATE KIT2Cleared 510(K)
- K041976SMITH & NEPHEW GRAFT DELIVERY SYSTEM2Cleared 510(K)
- K041504HEMAMYST SURGICAL APPLICATOR SYSTEM, MODEL H-AS012Cleared 510(K)
- K041344OPEN BORE SYRINGE2Cleared 510(K)
- K041084CLIP-ON SPACER 20%; 40%; 50%2Cleared 510(K)
- K033739PHYSICIAN INDUSTRIES' DURAMETER SYRINGE2Cleared 510(K)
- K041590AUTODETECT SYRINGE2Cleared 510(K)
- K033721VASCULAR SOLUTIONS AUTO-FILL SYRINGE KIT2Cleared 510(K)
- K033794ULTICARE DISPOSABLE SYRINGE 3 ML/CC2Cleared 510(K)
- K033166KACEY INSULIN SYRINGE2Cleared 510(K)
- K030683NIPRO DISPOSABLE SYRINGES2Cleared 510(K)
- K031394AMERICAN SYRINGE COMPANY 1CC AND 3CC SYRINGE2Cleared 510(K)
- K021993SHANCHUAN SYRINGE2Cleared 510(K)
- K030208IMBIBE II SYRINGE2Cleared 510(K)
- K023074IMBIBE BONE MARROW ASPIRATION SYRINGE2Cleared 510(K)
- K024052MERIT MEDICAL 1-ML SYRINGE2Cleared 510(K)
- K023752BD INTEGRA SYRINGE2Cleared 510(K)
- K024112BD INSULIN SYRINGE2Cleared 510(K)
- K023271TERUMO SYRINGE WITH/WITHOUT NEEDLE2Cleared 510(K)
- K023108STERIPACK STERILE DISPOSABLE SYRINGE & STERILE DISPOSABLE INSULIN SYRINGE2Cleared 510(K)
- K022159PISTON SYRINGE & HYPODERMIC NEEDLE2Cleared 510(K)
- K022495GETTIG DISPOSABLE SYRINGES2Cleared 510(K)
- K023088BONE GRAFT SYRINGE, MODEL 8600-00X02Cleared 510(K)
- K022246MODIFICATION TO SYMPHONY GRAFT DELIVERY SYSTEM2Cleared 510(K)
- K021084LIGHT SABER SPINAL NEEDLE2Cleared 510(K)
- K021071PCCS GRAFT DELIVERY SYSTEM2Cleared 510(K)
- K014114GLUCOPRO SYRINGE, MODEL GPSY-XXXXXXXX2Cleared 510(K)
- K020666DUPLOJECT EASY-PREP SYSTEM 1ML, 2ML, 5ML2Cleared 510(K)
- K014088DUPLOREACH2Cleared 510(K)
- K021197SUREONE INSULIN SYRINGE, 31 GAUGE X 5/162Cleared 510(K)
- K020252SMARTJET GRAFTING LIQUID APPLICATOR, MODELS SK/S & LK/22Cleared 510(K)
- K020147MAGELLAN RATIO DISPENSER KIT/MAGELLAN SPRAY TIP/MAGELLAN CANNULA TIP2Cleared 510(K)
- K014073HYPODERMIC NEEDLE-PRO INSULIN SYRINE & NEEDLE WITH NEEDLE PROTECTION DEVICE2Cleared 510(K)
- K012868MICROMEDICS FIBRIJET AEROSOL APPLICATOR2Cleared 510(K)
- K011087ORTHOVITA PISTON SYRINGE OR IMBIBE BONE MARROW ASPIRATION SYRINGE2Cleared 510(K)
- K011176REUSABLE GLASS SYRINGES2Cleared 510(K)
- K011951EZ SYRINGE2Cleared 510(K)
- K010692THE WAND PLUS COMPUTER CONTROLLED ANESTHETIC DELIVERY SYSTEM2Cleared 510(K)
- K010708APPLICATOR TIP/DUAL SPRAYER KIT2Cleared 510(K)
- K010890BD ULTRA-FINE II INSULIN SYRINGE-MINI NEEDLE, MODEL 30G * 3/16 (5MM)2Cleared 510(K)
- K010359INNOVO2Cleared 510(K)
- K003571SERONO FOR USE WITH GONAL-F 1200IU MULTI-DOSE ONLY AT 600IU/ML SYRINGE2Cleared 510(K)
- K002381PENTAFERTE SINGLE USE SYRINGES, MODEL SIZE=VARIOUS SIZES2Cleared 510(K)
- K002717STERILE PISTON SYRINGE2Cleared 510(K)
- K002127INJECTRITE-C15 AND INJECTRITE-C302Cleared 510(K)
- K002569GLUCOSOURCE INSULIN SYRINGES AND MALGAM SINGLE-USE INSULIN AND SINGLE USE HYPODERMIC SYRINGES2Cleared 510(K)
- K003193DUPLOGRIP2Cleared 510(K)
- K002921SUREONE INSULIN SYRINGE2Cleared 510(K)
- K001731AVID-NIT LOSS OF RESISTANCE SYRINGE2Cleared 510(K)
- K981089TISSOMAT AND SPRAY SET2Cleared 510(K)
- K001474TERUMO U-100 INSULIN SYRING2Cleared 510(K)
- K000747UNIVEC TWO PIECE SYRINGE2Cleared 510(K)
- K992404THE WAND2Cleared 510(K)
- K000456HARVEST TECHNOLOGIES DUAL LIQUID APPLICATOR, MODEL SK/S: HARVEST DUAL LIQUID APPLICATOR LK/22Cleared 510(K)
- K000438MULTI LUMEN SUCTION SYRINGE SPRAY DISPENSER2Cleared 510(K)
- K994023HAEMACURE HEMAMYST SURGICAL APPLICATOR SYSTEM H-AS012Cleared 510(K)
- K994230ULTICARE DISPOSABLE SYRINGE2Cleared 510(K)
- K993017PROFI DISPOSABLE SYRINGE, PROFI DISPOSABLE NEEDLE, DM JECT INSULIN SYRINGE2Cleared 510(K)
- K993995VEIN ENTRY INDICATOR DEVICE (VEID)2Cleared 510(K)
- K000144NIPRO INSULIN SYRINGE2Cleared 510(K)
- K000048SEALOUETTE FIBRIN SEALANT EXTENDED DROPLET APPLICATOR, MODEL TE-12Cleared 510(K)
- K994253VACLOK SYRINGE2Cleared 510(K)
- K993666DISETRONIC PEN P1002Cleared 510(K)
- K992351SEALOUETTE FIBRIN SEALANT APPLICATOR2Cleared 510(K)
- K992802TERUMO U-100 INSULIN SYRINGE2Cleared 510(K)
- K991225MTI 1 ML SYRINGE2Cleared 510(K)
- K990020TE ME NA LOSS OF RESISTANCE SYRINGE, 10CC2Cleared 510(K)
- K991758MONOJECT INSULIN SYRINGE2Cleared 510(K)
- K991039EASYSAFE RETRACTING NEEDLE SYRINGE2Cleared 510(K)
- K984017ALLISON MEDICAL INSULIN SYRINGE (AMIS)2Cleared 510(K)
- K983430LITE-TOUCH SYRINGE2Cleared 510(K)
- K983994UNIFINE2Cleared 510(K)
- K983974OWEN MUMFORD 3ML AUTOPEN2Cleared 510(K)
- K982966DISETRONIC PEN2Cleared 510(K)
- K980078PENETREASE2Cleared 510(K)
- K982842HUMAPEN AND HUMAPEN ERGO2Cleared 510(K)
- K982018LIGHT SABER ASPIRATION NEEDLE2Cleared 510(K)
- K972728STERILE WATER FOR INJECTION PREFILLED SYRING (SWFIPS)2Cleared 510(K)
- K981140MINRAD DRTS LIGHT SABER SYRINGE2Cleared 510(K)
- K980580BECTON DICKINSON SYRINGES2Cleared 510(K)
- K981797B-D PEN ULTRA2Cleared 510(K)
- K980987BECTON DICKINSON SYRINGE2Cleared 510(K)
- K963364GLASS VAN GLASS SYRINGES2Cleared 510(K)
- K980796TERUMO ALLERGY SYRINGE2Cleared 510(K)
- K980755B-D E ML PEN2Cleared 510(K)
- K980181TERUMO DISPOSABLE HYPODERMC SYRINGE2Cleared 510(K)
- K972900ULTRASAFE MODEL T200 INJECTOR2Cleared 510(K)
- K972877ULTRASAFE INJECTION SYSTEM MODEL C200 INJECTOR WITH NEEDLE GUARD2Cleared 510(K)
- K970419DAXOR MAX100 SYRINGE (MAX100)2Cleared 510(K)
- K973510DUPLOJECT (0.5/1.0 ML, 2.0 ML, 5.0 ML)2Cleared 510(K)
- K972878ULTRASAFE INJECTION SYSTEM NEEDLE GUARD, MODELS B50,B100L,B150,B225, AND B3002Cleared 510(K)
- K964597BIOSURGICAL, CORP. MULTI CHAMBER SUCTION SYRINGE2Cleared 510(K)
- K971664RAMY PISTON SYRINGE2Cleared 510(K)
- K972452RAMY INTEGRATED NEEDLE SYRINGE2Cleared 510(K)
- K964230CORELIFE2Cleared 510(K)
- K965030BRANNON ARTERIO-VENOUS PORTSYRINGE2Cleared 510(K)
- K962084OMNICAN SYRINGE2Cleared 510(K)
- K964060COPAXONE (COPOLYMER-1 FOR INJECTION) SELF-INJECTION ADMINISTRATION PACKAGE2Cleared 510(K)
- K945410IRT LOCKING SYRINGE2Cleared 510(K)
- K963260DRESSING CHANGE TRAYS2Cleared 510(K)
- K962042GLASS SYRINGE2Cleared 510(K)
- K962329GLOBAL LOSS OF RESISTANCE SYRINGE GLOR 102Cleared 510(K)
- K962614SHIFA STERILE DISPOSABLE SYRINGES2Cleared 510(K)
- K955606PISTON SYRINGE2Cleared 510(K)
- K960882CONTROL SYRINGE2Cleared 510(K)
- K960049BRANNON PORTSYRINGE2Cleared 510(K)
- K960047BRANNON PEDI PORTSYRINGE2Cleared 510(K)
- K953940TERUMO RETRACTABLE NEEDLE (RN) SYRINGE2Cleared 510(K)
- K955282THERMOGENESIS DROP APPLICATOR, KITS, SPRAY KITS AND TIPS2Cleared 510(K)
- K960248GENERAL PROCEDURE KIT2Cleared 510(K)
- K955164S.A.R.S. II (SEMI-AUTOMATIC-RECONSTITUTING-SYSTEM)2Cleared 510(K)
- K950666UNIQUE NEEDLE WITH FIRM GRIP SHIELD2Cleared 510(K)
- K950245UNIQUE NEEDLE2Cleared 510(K)
- K953626SYRINGE MAGNIFIER2Cleared 510(K)
- K950969DISPOSABLE SYRINGE2Cleared 510(K)
- K954064BECTON DICKINSON SYRINGSE2Cleared 510(K)
- K954337GENOTROPIN MIXER2Cleared 510(K)
- K951919B-D PEN ULTRA2Cleared 510(K)
- K954189EASI-JECTOR CONTROL SYSTEM2Cleared 510(K)
- K951025PISTON SYRINGE2Cleared 510(K)
- K952201PORT-A-CATH ACCESS KIT2Cleared 510(K)
- K952553ALPHA MEDICA DISPOSABLE, STERILE, NONPYROGENIC SYRINGE2Cleared 510(K)
- K944542REUSABLE ALL - GLASS SYRINGES2Cleared 510(K)
- K951980COLLAPSIBLE HYPODERMIC SYRINGE2Cleared 510(K)
- K952918PTFE SYRINGE FILTER2Cleared 510(K)
- K950824STRYKER DROP APPLICATOR, KITS, SPRAY APPLICATOR KIT, TIPS2Cleared 510(K)
- K951918SURGICAL TECHNOLOGIES, INC. SYRINGE2Cleared 510(K)
- K945592VLV SOLODRAW(TM) DUAL CHAMBER PISTON SYRINGE2Cleared 510(K)
- K951871PISTON SYRINGE2Cleared 510(K)
- K951619UNIVEC NONREUSABLE LOCKING SYRINGE2Cleared 510(K)
- K945797STERILE EMPTY PCA SYRINGE2Cleared 510(K)
- K942159NOVOPEN 1.52Cleared 510(K)
- K950133HYPODERMIC SYRINGE PISTON2Cleared 510(K)
- K946190DRUG DISPENSING SPIKE2Cleared 510(K)
- K945715MONOJECT(R) PISTON SYRINGES; 3,6,12,20,35 AND 60CC SIZES2Cleared 510(K)
- K945588DISPOSABLE 1CC SYRINGE WITH LUER LOCK2Cleared 510(K)
- K940635SAFE-1(TM) SYRINGE2Cleared 510(K)
- K942394SAFE VENT SYSTEM2Cleared 510(K)
- K945225DISPOSABLE SYRINGES AND DISPOSABLE NEEDLES2Cleared 510(K)
- K944920CG DISPOSABLE SYRINGE2Cleared 510(K)
- K936015DISPOSABLE DISC FILTER2Cleared 510(K)
- K944355NIPRO BRANDED DISPOSABLE SYRINGES, NEEDLES2Cleared 510(K)
- K941589SYRINGE FILTER DEVICES2Cleared 510(K)
- K941020DRUG RECONSTITUTION FILTER DEVICE2Cleared 510(K)
- K942221IRRIGATION TRAY WITH PISTON SYRINGE2Cleared 510(K)
- K942615SYRINGE2Cleared 510(K)
- K941095MEDSAVER SYRINGE2Cleared 510(K)
- K935092CONVENIENCE CONTOUR KITS REDI NURSE SYSTEM2Cleared 510(K)
- K941032UNKNOWN2Cleared 510(K)
- K941657BD MICRO FINE, ULTRA FINE, AND ALLERGY SYRINGE2Cleared 510(K)
- K9415621ML LUER-LOK SYRINGE2Cleared 510(K)
- K941545ADVANTAGE SYRINGE2Cleared 510(K)
- K925822CUSTOM SYRIGENE KITS2Cleared 510(K)
- K933335RIVER VIAL ADAPTER2Cleared 510(K)
- K931472CAREJECT DISPOSABLE SYRINGE AND NEEDLE2Cleared 510(K)
- K934561ONE TIME VIAL ACCESS SPIKE2Cleared 510(K)
- K920039MEDIJECT DISPOSABLE SYRINGES2Cleared 510(K)
- K932001ALLISON MEDICAL SYRINGE2Cleared 510(K)
- K932361BASIC SKIN PREP TRAY2Cleared 510(K)
- K923321EDGE SYRINGES AND NEEDLES2Cleared 510(K)
- K931095SPRING LOADED SYRINGE2Cleared 510(K)
- K931632I.D.A. SYRINGES2Cleared 510(K)
- K930791AMERICAN POWER CONVERSIONS, BACK-UPS 6002Cleared 510(K)
- K924511MONOJECT(R) 6 CC SAFETY SYRINGE2Cleared 510(K)
- K925548FIBRACOL COLLAGEN-ALGINATE DRESSING2Cleared 510(K)
- K923183GENESIS SPRAY TIP ATOMIZER2Cleared 510(K)
- K930847ARGYLE TURKEL SAFETY THORACENTESIS PROC. TRAY2Cleared 510(K)
- K921908NOVOLINPEN DIAL-A-DOSE INSULIN DELIVERY DEVICE2Cleared 510(K)
- K930321BECTON DICKINSON DISPOS. SYRINGES PLUNGER TIP MOD.2Cleared 510(K)
- K930342BECTON DICKINSON ARTERIAL BLOOD GAS KITS2Cleared 510(K)
- K926007ACCESSORY TO PISTON SYRINGE2Cleared 510(K)
- K915780RACK AND SYRINGES2Cleared 510(K)
- K924072BECTON DICKINSON SAFETY-LOK SYRINGE2Cleared 510(K)
- K922522MONOJECT SAFETY SYRINGE, 1 CC, 3CC AND 12 CC SIZES2Cleared 510(K)
- K922041PRIMARY SURGICAL DRESSING TRAY2Cleared 510(K)
- K922190LAPAROSCOPIC CHOLANGIOGRAPHY CATHETER2Cleared 510(K)
- K923645VISITEC ASPIRATING SYRINGE2Cleared 510(K)
- K921833ENDOPATH ENDO-SURGERY PERCUTANEOUS CATHETER INTROD2Cleared 510(K)
- K915676SPLATTER SHIELD2Cleared 510(K)
- K912437IRRIGATING SYRINGE2Cleared 510(K)
- K920422B-D INTERLINK SYRINGE CANNULA2Cleared 510(K)
- K920321BECTON DICKINSON SAFETY-LOK SYRINGE2Cleared 510(K)
- K920398CEPTI-SEAL DRESSING CHNG. KIT FOR CENT. VENOUS CAT2Cleared 510(K)
- K913541NEO-THOR THORACOSTOMY KIT2Cleared 510(K)
- K913540PEDIA-THOR THORACOSTOMY KIT2Cleared 510(K)
- K913602IDEAS' PORT2Cleared 510(K)
- K913114TRIM-PORT(TM) IMPLANT ACCESS SYST DUAL TITAN PORT2Cleared 510(K)
- K911440RAPI-JECT(R) SYRINGE2Cleared 510(K)
- K913694PALCO LABS LOADMATIC2Cleared 510(K)
- K913235DAVOL IMPLANT PORTS W/ATTACH HI PERF GROSHONG CATH2Cleared 510(K)
- K912330B-D(TM) MICROFINE(TM) IV PEN INJECTOR CAT. #3282042Cleared 510(K)
- K912111MODIFIED VERSION IMPLANTABLE VASCULAR ACCESS SYSTE2Cleared 510(K)
- K902401CELSITE(TM) IMPLANTABLE DRUG DELIVERY SYSTEM2Cleared 510(K)
- K910731DISPOSABLE RETRACTABLE NEEDLE SYRINGE2Cleared 510(K)
- K910520SAFETYSNAP SAFETY SYRINGE2Cleared 510(K)
- K905384DAVID SIMMONDS ANESTHESIA EXTENSION TUBES2Cleared 510(K)
- K904620STERAID DISPOSABLE SYRINGE2Cleared 510(K)
- K902178YUEFA DISPOSABLE SYRINGE2Cleared 510(K)
- K902157JOHNSON & JOHNSON DUAL SYRINGE APPLICATOR2Cleared 510(K)
- K904382SAFE-T-STIK2Cleared 510(K)
- K903426INSULIN SYRINGE GUIDE2Cleared 510(K)
- K895810SHARGHP SYRINGES, WITH AND WITHOUT NEEDLE2Cleared 510(K)
- K895980SHARGHP INSULIN SYRINGES2Cleared 510(K)
- K901546NEEDLEPOINT GUARD2Cleared 510(K)
- K902346DISPOSABLE CORONARY CONTROL SYRINGE2Cleared 510(K)
- K901508RETRAX SAFETY SYRINGE2Cleared 510(K)
- K901203HYPODERMIC SYRINGE LUER LOK2Cleared 510(K)
- K900857NON STERILE PARENTERAL SUPPLY KIT2Cleared 510(K)
- K900687SYRINGE DISPOSAL SYSTEM2Cleared 510(K)
- K897105CHEMO-SHIELD2Cleared 510(K)
- K895890AUTOPEN2Cleared 510(K)
- K896722PISTON SYRINGE2Cleared 510(K)
- K896086PROGUARD II(TM)2Cleared 510(K)
- K893233DISPOSABLE NEEDLE, ASPIRATION AND INJECTION2Cleared 510(K)
- K895831NEEDLEPOINT GUARD2Cleared 510(K)
- K895419DISPOSABLE DISC FILTER2Cleared 510(K)
- K895220THE ON-GARD RECAPPER2Cleared 510(K)
- K894206INTOPO2Cleared 510(K)
- K895203EN-TRAP SYRINGE2Cleared 510(K)
- K89480130-CS01, 30-CS02, 30-CS03 CONTROL SYRINGES2Cleared 510(K)
- K894335MODEL #535 PACU STRETCHER/BED & #530 ED/TRAUMA STR2Cleared 510(K)
- K894217SYRINGE TIP ADAPTOR2Cleared 510(K)
- K894177NEEDLE*LESS DRUG VIAL ADAPTER2Cleared 510(K)
- K893862FLEXGARD SYRINGE PROTECTOR2Cleared 510(K)
- K892430DISPOSABLE DISC FILTER2Cleared 510(K)
- K892428COMBI-CAP2Cleared 510(K)
- K892405NEEDLEPOINT GUARD2Cleared 510(K)
- K891467LOKSHOT PISTON SYRINGE2Cleared 510(K)
- K884841RETRACTABLE PISTON SYRINGE W/LUER-LOCK COLLAR2Cleared 510(K)
- K883073N.M.D.C. USER PROTECTIVE HYPODERMIC SYRINGE SYSTEM2Cleared 510(K)
- K890155MDP DISPOSABLE SYRINGE2Cleared 510(K)
- K884921HEMO-SANITAS SYRINGE2Cleared 510(K)
- K890082DISPENSING PIN/CHEMOTHERAPY DISPENSING PIN2Cleared 510(K)
- K884233QUADROJECT(TM)2Cleared 510(K)
- K882975RE-VENT ARTERIAL BLOOD SAMPLER AND/OR BIOSAMPLER2Cleared 510(K)
- K881791STERA DISPOSABLE SYRINGES2Cleared 510(K)
- K884985MODIFIED 10CC SYRINGE CONTROL RING SET2Cleared 510(K)
- K884497CONTROL SYRINGE2Cleared 510(K)
- K884589FRANTZ MEDICAL SHARPS COLLECTOR2Cleared 510(K)
- K881454RETRACTABLE NEEDLE 3CC SYRINGE2Cleared 510(K)
- K881867NEEDLE EJECTOR2Cleared 510(K)
- K881866NEEDLE REMOVER2Cleared 510(K)
- K883078INSULIN SYRINGE2Cleared 510(K)
- K883033PISTON SYRINGE WITH NEEDLE2Cleared 510(K)
- K883220EXTRAVAKIT FOR RADIOLOGICAL APPLICATIONS2Cleared 510(K)
- K883955SINGLE-FIL(TM) SYRINGE2Cleared 510(K)
- K883242EXTRAVAKIT FOR DIMETHYLSULFOXIDE (DMSO)2Cleared 510(K)
- K883227SKIFA, PLASTIC DISPOSABLE SYRINGE2Cleared 510(K)
- K883744MANAN HUBER STYLE INFUSION NEEDLE2Cleared 510(K)
- K883614CYTOGUARD(R)2Cleared 510(K)
- K883311COUNT-A-DOSE2Cleared 510(K)
- K882536OPHTHALMIC PAO VALVE2Cleared 510(K)
- K882403OPHTHALMIC FLUID INJECTOR2Cleared 510(K)
- K882114AMISCO U-100 INSULIN SYRINGE2Cleared 510(K)
- K881775BD MICROFINE IV PEN INJECTOR2Cleared 510(K)
- K883094MX350 (SERIES) CONTROL SYRINGE2Cleared 510(K)
- K882025MODIFIED EXTRAVAKIT2Cleared 510(K)
- K881980RETROJECT(TM) ANTI-AIDS SYRINGE W/RETRAC. NEEDLE2Cleared 510(K)
- K880963HAC AUTOLOGY CENTERS DISPENSING KIT FOR FIB.CON.2Cleared 510(K)
- K882335DISPOSABLE SYRINGE2Cleared 510(K)
- K880693MEDSURG MYELOGRAM TRAY2Cleared 510(K)
- K875297JAMES TENDOS (SYRINGE HOLDER)2Cleared 510(K)
- K880894ALLERGIST SYRINGES2Cleared 510(K)
- K880342UROSTHESIA2Cleared 510(K)
- K880350YUE/FA DISPOSABLE SYRINGE2Cleared 510(K)
- K875097DISPOSABLE SYRINGE2Cleared 510(K)
- K875148MEDICRAT, HYPODERMIC SYRINGES & NEEDLES2Cleared 510(K)
- K874807EXTRAVAKIT2Cleared 510(K)
- K87474710CC SYRINGE CONTROL RING SET2Cleared 510(K)
- K874579COEUR CONTROL SYRINGE2Cleared 510(K)
- K872565DUOFLO DISPENSER2Cleared 510(K)
- K871616CUSTOM PROCEDURE TRAYS2Cleared 510(K)
- K8737093 RING ATTACHMENT FOR SYRINGES2Cleared 510(K)
- K87358810CC CONTROL SYRINGE2Cleared 510(K)
- K872805NOVOLINPEN DIAL-A-DOSE INSULIN DELIVERY SYSTEM2Cleared 510(K)
- K872743BAXA TUBING SETS (FOR PHARMACY PUMP)2Cleared 510(K)
- K872944LOOK SPRING-ASSIST SYRINGES2Cleared 510(K)
- K872820SAFETY SYRINGE2Cleared 510(K)
- K871965JMS NEEDLES AND JMS SYRINGES2Cleared 510(K)
- K871443CASANDRA SYRINGE CAP2Cleared 510(K)
- K860688MONOJECT PHARMACY TRAY2Cleared 510(K)
- K871007ANTI NEEDLE STRIKE ANTI DRUG ABUSE HYPO. SYRINGE2Cleared 510(K)
- K870518SURGITEK PHYSICIAN DISPEN. PATIENT SELF-INJECT KIT2Cleared 510(K)
- K870192DISPOSABLE SYRINGE TUBERCULIN W/NEEDLE2Cleared 510(K)
- K870191DISPOSABLE SYRINGE WITH NEEDLE2Cleared 510(K)
- K870190DISPOSABLE SYRINGE W/O NEEDLE2Cleared 510(K)
- K870078ACCUPEN(R)2Cleared 510(K)
- K870018E-Z JECT INSULIN SYRINGE2Cleared 510(K)
- K864541BT HYPODERMIC SYRINGE2Cleared 510(K)
- K861686NOVOPEN SYSTEM (INSULIN SYRINGE)2Cleared 510(K)
- K864407REFILLABLE SYRINGE2Cleared 510(K)
- K864781MACLEE/BOIN MEDICA STERILE NEEDLE/SYRINGE 20ML/CC2Cleared 510(K)
- K864779MACLEE/BOIN MEDICA STERILE NEEDLE/SYRINGE 50ML/CC2Cleared 510(K)
- K864777MACLEE/BOIN MEDICA STERILE NEEDLE & SYRINGE 3ML/CC2Cleared 510(K)
- K864778MACLEE/BOIN MEDICA STERILE NEEDLE/SYRINGE 30ML/CC2Cleared 510(K)
- K864747VARIOUS SYRINGES W/NEEDLES, W/OUT NEEDLES, NEEDLES2Cleared 510(K)
- K864783MACLEE/BOIN MEDICA STERILE NEEDLE & SYRINGE 5ML/CC2Cleared 510(K)
- K864782MACLEE/BOIN MEDICA STERILE NEEDLE/SYRINGE 10ML/CC2Cleared 510(K)
- K864780MACLEE/BOIN MEDICA STERILE NEEDLE & SYRINGE 1ML/CC2Cleared 510(K)
- K864414SEAL SYRINGE (3CC,5CC,12CC,20CC,30CC & 50CC)2Cleared 510(K)
- K864761USI AUTOJECT INSULIN SYRINGE2Cleared 510(K)
- K8645553 RING ATTACHMENT2Cleared 510(K)
- K861276TAMPER PROOF CAP2Cleared 510(K)
- K861153DISPOSABLE SYRINGES AND HYPODERMIC NEEDLES2Cleared 510(K)
- K853450STERISTORAGE CONTAINER2Cleared 510(K)
- K854877ACU-SYRINGE W/WO NEEDLES2Cleared 510(K)
- K854563DISPOSABLE SYRINGES & NEEDLES2Cleared 510(K)
- K853120ADDITIVE EXTENSION SYRINGE2Cleared 510(K)
- K852503R.R. PRONTO SIRINGA2Cleared 510(K)
- K854255SPAN / AID SYRINGE2Cleared 510(K)
- K853838JMS LCC INSULIN SYRINGE2Cleared 510(K)
- K852444ASIK 'ONCE' SYRINGE2Cleared 510(K)
- K852443PHARMA-PLAST CLINIPAK2Cleared 510(K)
- K852990PAO VALUE2Cleared 510(K)
- K852819STERILE DISPOSABLE SYRINGE(3 PIECES)2Cleared 510(K)
- K852304SAFE-N-JECT2Cleared 510(K)
- K852818STERILE DISPOSABLE SYRINGES(2 PIECES)2Cleared 510(K)
- K851523DISPOSABLE PLASTIC SYRINGES2Cleared 510(K)
- K852640MONOJECT STERILE 35CC SYRINGES2Cleared 510(K)
- K852607MONJECT STERILE 20CC SYRINGES2Cleared 510(K)
- K852580MONOJECT STERILE 60CC SYRINGES2Cleared 510(K)
- K852588MONOJECT STERILE 6CC SYRINGE W/ & WO/ NEEDLES2Cleared 510(K)
- K852544MONOJECT STERILE 3CC SYRINGES W/ & WO/ NEEDLES2Cleared 510(K)
- K851464PULSE MED CUSTOM PKG. PROC. TRAYS OPERATING ROOMS2Cleared 510(K)
- K851519FORTUNA DISPOSABLE SYRINGES2Cleared 510(K)
- K851089MONOJECT STERILE 12CC SYRINGES, W/WO NEEDLES2Cleared 510(K)
- K851090MONOJECT STERILE 1/2 CC & 1CC SYRINGES W & W/O NEE2Cleared 510(K)
- K850958BLOOD GAS SAMPLER KIT2Cleared 510(K)
- K844475SPECIMEN COLLECTION & TRANSPORT SYSTEM2Cleared 510(K)
- K844106SYRINGE W/NEEDLE COMBIN & SYRINGE ONLY2Cleared 510(K)
- K844796MICRO-BETA U100 SYRINGE2Cleared 510(K)
- K843887IV JET2Cleared 510(K)
- K843415TOP HYPODERMIC SYRINGE LUER LOCK2Cleared 510(K)
- K844306GAINOR MEDICAL SYRINGE2Cleared 510(K)
- K843473PHARMA-PLAST INSULIN SYRINGE2Cleared 510(K)
- K843472PHARMA-PLAST SYRINGE WITH NEEDLE2Cleared 510(K)
- K843471PHARMA-PLAST SYRINGE2Cleared 510(K)
- K843414TOP HYPODERMIC SYRINGE PISTON2Cleared 510(K)
- K841949DOSE RELEASE OF STERILIZATION LOTS2Cleared 510(K)
- K842227AIMED DISPOSABLE SYRINGE, VARIOUS SIZES2Cleared 510(K)
- K841566HESUNG DISPOSABLE SYRINGE2Cleared 510(K)
- K841931DISPO. AES DISPOS. SYRINGE W/NEEDLE2Cleared 510(K)
- K841810MARK5 ARTERIAL BLOOD GAS KIT2Cleared 510(K)
- K841578DISPOSABLE SYRINGE2Cleared 510(K)
- K840490FLUID REMOVAL ASSEMBLY2Cleared 510(K)
- K833706CLICK-COUNT U100 INSULIN SYRINGE2Cleared 510(K)
- K840924SYRINGE, PISTON, ARTERIAL BLOOD SAMPL2Cleared 510(K)
- K834256PBC SYRINGE IRRIGATING2Cleared 510(K)
- K840192PISTON SYRINGE DISPOS. STERILE SYRING2Cleared 510(K)
- K834548HYPODERMIC SYRINGES & NEEDLES2Cleared 510(K)
- K834368SURGICAL DISPOSABLE STERILE & NONSTERIL2Cleared 510(K)
- K840082STERILE INSULIN DISPOS. NEEDLE/SYRINGE2Cleared 510(K)
- K840083STERILE INSULIN DISPOS. NEEDLE/GREEN2Cleared 510(K)
- K833399SYRINGE2Cleared 510(K)
- K834165SYRINGE2Cleared 510(K)
- K833435MULTI PURPOSE SYRINGE2Cleared 510(K)
- K833493DISPOSABLE SYRINGES & NEEDLES2Cleared 510(K)
- K833460SYRINGE,PISTON NEEDLE, HOLLOW LUMEN2Cleared 510(K)
- K832605TRANCOJECT DISPOSABLE SYRINGES2Cleared 510(K)
- K832761AIR FLUID EXCHANGE PUMP2Cleared 510(K)
- K832621TOP DISPOSABLE PLASTIC SYRINGES2Cleared 510(K)
- K832658DIRECTOR2Cleared 510(K)
- K832101STERILE DISPOSABLE SYRINGE2Cleared 510(K)
- K823521STERILE HD CVP TRAY2Cleared 510(K)
- K823537GLUCOSE REAGENT2Cleared 510(K)
- K823527SUBCLAVIAN INSERTION KIT2Cleared 510(K)
- K823056THE INGLEFIELD MAGIC RING2Cleared 510(K)
- K8227749110 SYRINGE2Cleared 510(K)
- K822159ANGIOUROGRAPHY KIT2Cleared 510(K)
- K822928DISPOSABLE MICRO-INFUSION SYSTEM2Cleared 510(K)
- K822185LARYNGEAL SYRINGE2Cleared 510(K)
- K822760ARTERIAL LINE KIT2Cleared 510(K)
- K822420REPLAM HYDROXYAPATATITE2Cleared 510(K)
- K822533SYRINGES(3-PARTS SINGLE USE)2Cleared 510(K)
- K822534NEEDLES(HYPODERMIC)2Cleared 510(K)
- K822532SYRINGES(2-PARTS SINGLE USE)2Cleared 510(K)
- K822238DISPOSABLE TAIYANG SYRINGE2Cleared 510(K)
- K822083U-100 INSULIN SYRINGE2Cleared 510(K)
- K822029MONOJET 520 20CC SYRINGES W/NEEDLES2Cleared 510(K)
- K821671DISPO. AES.2Cleared 510(K)
- K821528SYRINGE, PISTON2Cleared 510(K)
- K821537HENKE DISPOSABLE SYRINGE2Cleared 510(K)
- K821233DISPOSABLE PLASTIC SYRINGE W/NEEDLE2Cleared 510(K)
- K821096A-LINER2Cleared 510(K)
- K820384GLASS SYRINGES, DRUG, LUER LOCK2Cleared 510(K)
- K820716MONOJECT 512 SYRINGES W/WO NEEDLES2Cleared 510(K)
- K813157COLORLESS DISPOSIBLE PLASTIC SYRINGES2Cleared 510(K)
- K820062DISPOSABLE PLASTIC SYRINGE & NEEDLE2Cleared 510(K)
- K820294BOSTON SYRINGE2Cleared 510(K)
- K820449PHARMACEUTICALS MOD. 1CC-1,2,3 THRU 50CC2Cleared 510(K)
- K820454THE RED CAP2Cleared 510(K)
- K820164EMPTY STERILE CARPUJECT2Cleared 510(K)
- K813646JMS DISPOSABLE SYRINGE2Cleared 510(K)
- K813647PBC SYRINGE2Cleared 510(K)
- K813480MONOJECT M560 60CC SYRINGES2Cleared 510(K)
- K81317520CC GLASS CONTROL SYRINGE2Cleared 510(K)
- K812888SYRINGE, PISTON2Cleared 510(K)
- K812934MONOJECT PREFILLED SYRINGES2Cleared 510(K)
- K812748MONOJECT M535 35CC SYRINGE2Cleared 510(K)
- K812560MDM ARTERIAL BLOOD GAS SYRINGE2Cleared 510(K)
- K812023MONOJECT STERILE M506 6CC SYRINGES2Cleared 510(K)
- K811505MONOJECT STERILE M503 3CC SYRINGES2Cleared 510(K)
- K811009PREFILLED PULSATOR SYRINGE2Cleared 510(K)
- K811167FOCUS STERILE SYRINGES2Cleared 510(K)
- K810995PREFILLED PULSATOR SYRINGE2Cleared 510(K)
- K811065PISTON SYRINGE2Cleared 510(K)
- K803302PREHEPARINZED SYRINGE2Cleared 510(K)
- K803204IRRIGATION PISTON2Cleared 510(K)
- K803198IRRIGATION SET W/PISTON SYRINGE2Cleared 510(K)
- K802406CYTOTRAN I BONE MARROW ASPIRATION SYSTEM2Cleared 510(K)
- K801430CONTROL SYRINGE2Cleared 510(K)
- K801311BURRON MULTI-AD SYRINGE CAP2Cleared 510(K)
- K792520ANESTHESIA & HOSPITAL SYRINGE HOLDER2Cleared 510(K)
- K792033DYNACOR STERILE BLOOD GAS SPECIMEN TRAY2Cleared 510(K)
- K791660PREPACELL-BONE MARROW SAMPLER2Cleared 510(K)
- K790409LOW DEAD SPACE INSULIN SYRINGE2Cleared 510(K)
- K781978PUNCTURE KIT, DISPOSALBE VEIN2Cleared 510(K)
- K781917MUCUS ASPIRATOR2Cleared 510(K)
- K781154SYRINGE, INSULIN, HYPOTIP2Cleared 510(K)
- K780595MINI-IRRIGATION TRAY2Cleared 510(K)
- K780602SYRINGE (IRRIGATION)2Cleared 510(K)
- K780600IRRIGATION TRAY2Cleared 510(K)
- K780550STERILE AIR SYRINGE2Cleared 510(K)
- K772338SYRINGE, BLOOD, SAMPLING, ARTERIAL2Cleared 510(K)
- K771888SYRINGE, DISPOSABLE2Cleared 510(K)
- K771584ARTEOIAL BLOOD SAMPLING KIT 2D90142Cleared 510(K)
- K771272DISP. SYRINGES: 2,5 & L0 MI.2Cleared 510(K)
- K771359ALLERGIST PACK SYRINGES2Cleared 510(K)
- K770850TRAY, BLOOD GAS, ARTERIAL, #40142Cleared 510(K)
- K771205HYPODERMIC SYRINGE2Cleared 510(K)
- K770852SYRINGE, BLOOD SAMPLING, ARTERIAL, #40152Cleared 510(K)
- K770851SYRINGE, BLOOD SAMPLING, ARTERIAL, #40162Cleared 510(K)
- K770361TRAY, BLOOD GAS, CAT. NO. 40102Cleared 510(K)
- K770238OVERDOSE KIT2Cleared 510(K)
- K761158FLUID DISPENSING SYSTEM2Cleared 510(K)
- K760392SYRINGES2Cleared 510(K)
- K760004SYRINGE, DISPOSABLE, ALL PLASTIC2Cleared 510(K)
- K760005SYRINGE, DISPOSABLE, GLASS & PLASTIC2Cleared 510(K)
- FMGStopcock, I.V. Set2Product Code
- FMINeedle, Hypodermic, Single Lumen2Product Code
- FMSBed, Pediatric Open Hospital2Product Code
- FMTWarmer, Infant Radiant2Product Code
- FMZIncubator, Neonatal2Product Code
- FNGLift, Patient, Ac-Powered2Product Code
- FNJBed, Manual1Product Code
- FNKBed, Hydraulic, Adjustable Hospital1Product Code
- FNLBed, Ac-Powered Adjustable Hospital2Product Code
- FNMMattress, Air Flotation, Alternating Pressure2Product Code
- FNNNipple, Lambs Feeding1Product Code
- FODDevice, Occlusion, Umbilical1Product Code
- FOHMattress, Water, Temperature Regulated1Product Code
- FOKPad, Neonatal Eye1Product Code
- FOSCatheter, Umbilical Artery2Product Code
- FOZCatheter, Intravascular, Therapeutic, Short-Term Less Than 30 Days2Product Code
- FPASet, Administration, Intravascular2Product Code
- FPBFilter, Infusion Line2Product Code
- FPKTubing, Fluid Delivery2Product Code
- FPLIncubator, Neonatal Transport2Product Code
- FQHLavage, Jet2Product Code
- FQJSupport, Scrotal, Therapeutic1Product Code
- FQKBinder, Perineal1Product Code
- FQLStocking, Medical Support (For General Medical Purposes)1Product Code
- FQMBandage, Elastic1Product Code
- FRFCleaner, Air, Medical Recirculating2Product Code
- FRLFiber, Medical, Absorbent1Product Code
- FRNPump, Infusion2Product Code
- FRPHolder, Infant Position1Product Code
- FRRChamber, Reverse Isolation, Patient Care2Product Code
- FSALift, Patient, Non-Ac-Powered1Product Code
- FSDBinder, Abdominal1Product Code
- HEFBinder, Breast1Product Code
- HFSShield, Nipple1Product Code
- IKYMattress, Flotation Therapy, Non-Powered1Product Code
- KMKDevice, Intravascular Catheter Securement1Product Code
- KMOBinder, Elastic1Product Code
- KPEContainer, I.V.2Product Code
- KYPSnake Bite Suction Kit1Product Code
- KYQKit, Chemical Snake-Bite3Product Code
- KZDInfusor, Pressure, For I.V. Bags1Product Code
- KZEInjector, Fluid, Non-Electrically Powered2Product Code
- LBIUnit, Neonatal Phototherapy2Product Code
- LDRController, Infusion, Intravascular, Electronic2Product Code
- LGMChamber, Patient Isolation2Product Code
- LGNChamber, Patient Transport Isolation2Product Code
- LGZWarmer, Thermal, Infusion Fluid2Product Code
- LHFWarmer, Microwave, Infusion Fluid2Product Code
- LHISet, I.V. Fluid Transfer2Product Code
- LJLDetectors And Removers, Lice, (Including Combs)1Product Code
- LJSCatheter, Intravascular, Therapeutic, Long-Term Greater Than 30 Days2Product Code
- LJTPort & Catheter, Implanted, Subcutaneous, Intravascular2Product Code
- LLIBed, Therapeutic, Ac-Powered, Adjustable Home-Use2Product Code
- LLKLegging, Compression, Non-Inflatable2Product Code
- LZHPump, Infusion, Enteral2Product Code
- MDRBinder, Medical, Therapeutic1Product Code
- MEAPump, Infusion, Pca2Product Code
- MEBPump, Infusion, Elastomeric2Product Code
- MEGSyringe, Antistick2Product Code
- MHCNeedle, Interosseous2Product Code
- MHDPump, Infusion, Gallstone Dissolution2Product Code
- MJFCheck Valve, Retrograde Flow (In-Line)2Product Code
- MMKContainer, Sharps2Product Code
- MQXNeedle, Acupuncture, Single Use2Product Code
- MRZAccessories, Pump, Infusion2Product Code
- MZRTopical Approximation System1Product Code
- NEPSystem/Device, Pharmacy Compounding2Product Code
- NGTSaline, Vascular Access Flush2Product Code
- NKKNeedle, Hypodermic, Single Lumen, Reprocessed2Product Code
- NKNSyringe, Piston, Reprocessed2Product Code
- NRWStimulator, Intramuscular, Automatic2Product Code
- NSCInjector, Pen2Product Code
- NTCNursing Pad, Hydrogel1Product Code
- NTXNursing Pad, Polyurethane Pad With Starch Copolymer, Glycerin, And Surfactant (F-68)1Product Code
- NXHNursing Pad, Cohesive Gel1Product Code
- NZGBassinet, Hospital2Product Code
- NZWHeparin, Vascular Access Flush2Product Code
- NZXWater, Vascular Access Flush2Product Code
- OBKPort, Protector/Cushion2Product Code
- ODIAdministration Set Docking Station2Product Code
- ODYTunneled Catheter Remover2Product Code
- OJAIntravenous Extension Tubing Set2Product Code
- OKCImplanted Subcutaneous Securement Catheter2Product Code
- OKEPort Introducer Kit2Product Code
- OKLIntravascular Administration Set, Automated Air Removal System2Product Code
- OMFPercutaneous, Implanted, Long-Term Intravascular Catheter Accessory For Catheter Position2Product Code
- ONBClosed Antineoplastic And Hazardous Drug Reconstitution And Transfer System2Product Code
- ONMRadiant Infant Warmer Cabinet2Product Code
- PUKAdministration Set Securement Device1Product Code
- OPPPump, Infusion, Insulin Bolus2Product Code
- OSIBariatric Bed2Product Code
- OUWInfant Positioner, Rx, Use In Highly Monitored Setting1Product Code
- OWLPeripheral Catheter Insertion Kit2Product Code
- PDHBlanket, Neonatal Phototherapy2Product Code
- PEFHeparin Flush In 0.45% Sodium Chloride2Product Code
- PEZCentral Venous Catheter Dressing Change Kit2Product Code
- PHCInfusion Safety Management Software2Product Code
- PKPImmunoglobulin G (Igg) Infusion System2Product Code
- PMSPeripheral Intravenous (Piv) Infiltration Monitor2Product Code
- PNDMidline Catheter2Product Code
- POQBlood Transfusion Kit2Product Code
- PORParenteral Administration Kit2Product Code
- PQHIodinated Contrast Media Transfer Tubing Set2Product Code
- PQXEpinephrine Syringe2Product Code
- PRNPediatric Position Holder1Product Code
- PTDSubcutaneous Implanted Apheresis Port2Product Code
- PTINon-Coring (Huber) Needle2Product Code
- PUNLice Removal Kit Containing A Solution1Product Code
- PURVacuum Syringe2Product Code
- PVZNon-Stainless Steel Needle2Product Code
- PWHAdministrations Sets With Neuraxial Connectors2Product Code
- PWNBaby Care Kit2Product Code
- PWOBlood Administration Kit2Product Code
- PWQBuret Administration Intravenous Kit2Product Code
- PWRCatheter Repair Kit2Product Code
- PWXInsect Sting Emergency Kit1Product Code
- PWYLumbar Puncture Tray (Adult & Pediatric)2Product Code
- PXBPercutaneous Introducer Kit2Product Code
- PXIThoracentesis Tray2Product Code
- PXJUmbilical Catheter Insertion Tray2Product Code
- PXKVascular Access Port Kit2Product Code
- PXLVenipuncture Kit2Product Code
- PYRNeuraxial Administration Set - Intrathecal Delivery2Product Code
- PZWCatheter Access Cover, Tamper-Resistant2Product Code
- QBLPiston Syringe Lever2Product Code
- QDMMidazolam Syringe2Product Code
- QEHPiston Syringe With Neuraxial Connector – Epidural, Peripheral, And/Or Indirect Cerebral Spinal Fluid Contact2Product Code
- QJYInfusion Pump, Drug Specific, Pharmacy-Filled2Product Code
- QLFOn-Body Injector2Product Code
- QLYOphthalmic Syringe2Product Code
- QMTPrep Kit – Vaccine Injection2Product Code
- QNQLow Dead Space Piston Syringe2Product Code
- QNSLow Dead Space Needle, Single Lumen, Hypodermic2Product Code
- QOGInjection Data Capture Device2Product Code
- QOIIntravenous Catheter Force-Activated Separation Device.2Product Code
- QTISaline Vascular Access Flush With Integrated Alcohol Disinfectant Device2Product Code
- QYMOphthalmic Needle2Product Code
- SCLAllergen And Vaccine Delivery Needles2Product Code
- SEFCentral Venous Catheter With Manual Insertion System2Product Code
- Subpart F—Neurological Therapeutic DevicesCFR Sub-Part
- Subpart F—Physical Medicine Therapeutic DevicesCFR Sub-Part
- Subpart F—Therapeutic DevicesCFR Sub-Part
- Subpart G—General Hospital and Personal Use Miscellaneous DevicesCFR Sub-Part
- Subpart G—Miscellaneous DevicesCFR Sub-Part
- HematologyReview Panel
- ImmunologyReview Panel
- MicrobiologyReview Panel
- NeurologyReview Panel
- Obstetrical and GynecologicalReview Panel
- OphthalmicReview Panel
- OrthopedicReview Panel
- PathologyReview Panel
- Physical MedicineReview Panel
- RadiologyReview Panel
- General and Plastic SurgeryReview Panel
- ToxicologyReview Panel
- Medical GeneticsReview Panel
- UnknownReview Panel
S dispensing line
- Page Type
- Cleared 510(K)
- FDA Hosted PDF* The FDA doesn't provide PDFs for all submissions.
- 510(k) Number
- K192770
- 510(k) Type
- Traditional
- Applicant
- AEA srl
- Country
- Italy
- FDA Decision
- Substantially Equivalent
- Decision Date
- 12/17/2020
- Days to Decision
- 444 days
- Submission Type
- Summary