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
- FMGStopcock, I.V. Set2Product Code
- FMINeedle, Hypodermic, Single Lumen2Product Code
- K252631Profoject™ Disposable Needle2Cleared 510(K)
- K250724Intraosseous Infusion Needles2Cleared 510(K)
- K250284TSK SELECT™ Needle2Cleared 510(K)
- K251447K-Pack Embrace Active Safety Needle (KNAS-2516RB, KNAS-2525RB)2Cleared 510(K)
- K24330927G x 1/2 TW K-Pack Surshield Needle (KN-S2713RBT)2Cleared 510(K)
- K240355FROG (Filter Removal of Glass)2Cleared 510(K)
- K243581K-Pack Enhance Needle (KH-2713RBBTC and KH-2913RBBTC)2Cleared 510(K)
- K250658SureFine Pen Needle2Cleared 510(K)
- K243806Safety Winged Blood Collection Sets2Cleared 510(K)
- K242741ACE Cannula2Cleared 510(K)
- K242632Verifine® Pen Needles2Cleared 510(K)
- K240915ZIEN IO Intraosseous Access System2Cleared 510(K)
- K232165Sterile Safety Hypodermic Needles for Single Use; Sterile Hypodermic Needles for Single Use- Disposable Needles; Sterile Hypodermic Needles for Single Use- Self-sealing Hypodermic Needles2Cleared 510(K)
- K233037Sterile Hypodermic Needles for Single Use2Cleared 510(K)
- K233343SteriCap Safety Needle; VitreJect Safety Needle2Cleared 510(K)
- K230070MESORAM® Hypodermic Needle (710301); MESORAM® Hypodermic Needle (710302); MESORAM® Hypodermic Needle (712305); MESORAM® Hypodermic Needle (712315); MESORAM® Hypodermic Needle (710303); MESORAM® Hypodermic Needle (710307); MESORAM® Hypodermic Needle (710306); MESORAM® Hypodermic Needle (712308); MESORAM® Hypodermic Needle (712318); MESORAM® Hypodermic Needle (712303); MESORAM® Hypodermic Needle (712307); MESORAM® Hypodermic Needle (712306); MESORAM® Hypodermic Needle (812400); MESORAM®2Cleared 510(K)
- K230043Insulin Pen Needle2Cleared 510(K)
- K230959VitreJect® Needle; OcuSafe® Needle2Cleared 510(K)
- K231723Sterile Safety Hypodermic Needles for Single Use2Cleared 510(K)
- K231729Sterile syringes for single use with/without needle2Cleared 510(K)
- K231720Sterile Hypodermic Needles for Single Use2Cleared 510(K)
- K231255NovoFine® Plus2Cleared 510(K)
- K231261Altaviz Needle Kit II2Cleared 510(K)
- K231924EZ-IO Intraosseous Vascular Access System2Cleared 510(K)
- K230635Pen Needle2Cleared 510(K)
- K222852Nipro SafeTouch Needle; Nipro Syringe with SafeTouch Needle2Cleared 510(K)
- K222739Disposable Insulin Pen Needle2Cleared 510(K)
- K222417Shina Safety Needle2Cleared 510(K)
- K223327Sterile Aesthetic Cannula and Hypodermic Needle2Cleared 510(K)
- K222271Verisafe Safety sterile needles2Cleared 510(K)
- K203792Insupen Pen needle, Insupen ORIGINAL Pen Needle, Insupen ADVANCED pen needle2Cleared 510(K)
- K223286BD AutoShield Duo™ Pen Needle2Cleared 510(K)
- K223334Sterile Hypodermic Needles for Single Use2Cleared 510(K)
- K214004CCBIO ASCPO Needle2Cleared 510(K)
- K222681Altaviz Needle Kit2Cleared 510(K)
- K223353DropSafeTM SicuraTM2Cleared 510(K)
- K221178Disposable Insulin Pen Needle2Cleared 510(K)
- K222124Sterile Hypodermic Syringe with/without Needle, Hypodermic Needle2Cleared 510(K)
- K220890IO Needle Safety Sheath2Cleared 510(K)
- K213183Safety Insulin Pen Needles2Cleared 510(K)
- K221080Sterile Safety Hypodermic Needles for Single Use2Cleared 510(K)
- K221066Sterile Hypodermic Needles for Single Use2Cleared 510(K)
- K220129Promisemed X-Safety Pen Needle2Cleared 510(K)
- K220603Disposable Medical Safety Hypodermic Needle2Cleared 510(K)
- K212095SurGuard3 Safety Hypodermic Needle2Cleared 510(K)
- K212972KDL Safety Needles2Cleared 510(K)
- K221176Insulin Pen Needle2Cleared 510(K)
- K213478BD Pen Needle2Cleared 510(K)
- K220614MEDOJECT fine Pen Needles2Cleared 510(K)
- K210748Well-life TM Pen Needles, Well-life TM Safety Pen Needles2Cleared 510(K)
- K213535Sterile Safety Hypodermic Needles for Single Use2Cleared 510(K)
- K212514Safety Pen Needle for Single Use, Insulin Pen Needles2Cleared 510(K)
- K214075Safety Blood Collection / Infusion Set (with/without needle holder), Blood Collection / Infusion Set (with/without needle holder)2Cleared 510(K)
- K210864Safety Pen Needle2Cleared 510(K)
- K211716DropSafe Safety Pen Needles2Cleared 510(K)
- K213407UltiCare Disposable Pen Needles2Cleared 510(K)
- K200932Blood Collection Needles2Cleared 510(K)
- K213156BD Nano 2nd Gen Pen Needle2Cleared 510(K)
- K212015BD Nano 2nd Gen Pen Needle2Cleared 510(K)
- K202319Insulin Pen Needle (Ordinary Type), Insulin Pen Needle (Safety Type)2Cleared 510(K)
- K211214Sterile Hypodermic Needles for Single Use2Cleared 510(K)
- K212805SteriCap Mini Needle and Standard Needles2Cleared 510(K)
- K210232Sterile Hypodermic Needles for Single Use2Cleared 510(K)
- K210399Unifine SafeControl2Cleared 510(K)
- K211634Hypodermic Needle-Pro EDGE Safety Device2Cleared 510(K)
- K211395NIO-I2Cleared 510(K)
- K211968NIO+ Adult2Cleared 510(K)
- K210059Promisemed Insulin Pen Needle2Cleared 510(K)
- K211293Safety Winged Blood Collection Sets2Cleared 510(K)
- K210258NovoFine2Cleared 510(K)
- K210065Verifine Safety Type Insulin Pen Needle2Cleared 510(K)
- K202492EZ-IO Intraosseous Vascular Access System2Cleared 510(K)
- K193422Easydrip Pen Needle, Easydrip Plus Pen Needle2Cleared 510(K)
- K202681Promisemed Covered Safety Pen Needle2Cleared 510(K)
- K202005NovoFine Plus 32G Tip x 4 mm2Cleared 510(K)
- K202682Promisemed Triple Safety Pen Needle2Cleared 510(K)
- K200017Eclipse DermaFlex Cannula2Cleared 510(K)
- K202340Droplet Pen Needle 30G & 33G2Cleared 510(K)
- K192464Injection Pen Needle2Cleared 510(K)
- K191644TK Safety Needle2Cleared 510(K)
- K192222EZ-Inject Single use Needle2Cleared 510(K)
- K192082Droplet Pen Needle 34G2Cleared 510(K)
- K192677Safety Insulin Pen Needle2Cleared 510(K)
- K190962Bella-mu2Cleared 510(K)
- K191643TK Sterile Hypodermic Needle2Cleared 510(K)
- K191488SAM IO Intraosseous Access System2Cleared 510(K)
- K191976Piper GO-IO Intraosseous Infusion System2Cleared 510(K)
- K191258Intraosseous infusion device2Cleared 510(K)
- K192057K-Pack II Needle - 27G x 1/2” Extra Thin Wall, K-Pack II Needle - 27G x 1/2” Ultra Thin Wall, K-Pack II Needle - 30G x 1/2” Extra Thin Wall, K-Pack II Needle - 30G x 1/2” Ultra Thin Wall2Cleared 510(K)
- K190538NIO-I2Cleared 510(K)
- K191853Dual-Safety Pen Needle2Cleared 510(K)
- K183016SteriCap Mini Needle2Cleared 510(K)
- K182770Adult Intraosseous Infusion Device2Cleared 510(K)
- K181447Safety insulin needle for single use2Cleared 510(K)
- K181730BD Vacutainer Eclipse UltraFill Blood Collection Needle2Cleared 510(K)
- K181508U&U Blood Collection Sets2Cleared 510(K)
- K182320BD Contoured Base Pen Needle2Cleared 510(K)
- K182146Sol-M Blood Collection Needles, Sol-Care Safety Blood Collection Needles, Sol-Care Safety Blood Collection Needle with Holders, Sol-M Blood Collection Set2Cleared 510(K)
- K181369Immucise Intradermal Injection System2Cleared 510(K)
- K180395EZ-IO Intraosseous Vascular Access System2Cleared 510(K)
- K181069Disposable Insulin Pen Needle2Cleared 510(K)
- K170824BD Vacutainer Eclipse Signal Blood Collection Needle2Cleared 510(K)
- K163578EasyTouch Safety Pen Needle2Cleared 510(K)
- K172095Autokeeper2Cleared 510(K)
- K173881Unifine SafeControl 5mm x 30G, Unifine SafeControl 8mm x 30G2Cleared 510(K)
- K180720Medifine Pen Needle 3 Bevel; Medifine Pen Needle Quinta 5 Bevel2Cleared 510(K)
- K172483Kopac Sterile Needle2Cleared 510(K)
- K172938Disposable Sterile Needle2Cleared 510(K)
- K173803Omnican fine2Cleared 510(K)
- K180545VACUETTE SAFELINK Holder with male luer lock2Cleared 510(K)
- K180259Sterile Hypodermic Needle for Single Use2Cleared 510(K)
- K173279RELI Safety Blood Collection Tube Holder, RELI Blood Collection Tube Holder2Cleared 510(K)
- K173757VACUETTE EVOPROTECT Safety Blood Collection / Infusion Set2Cleared 510(K)
- K180588FAST1™ Intraosseous Infusion System; FASTResponder™ Sternal Intraosseous Device2Cleared 510(K)
- K171982DROPLET PEN NEEDLE2Cleared 510(K)
- K173479NovoFine 32G Tip (0.23/0.25) x 6 mm ETW (extra thin wall)2Cleared 510(K)
- K170846Disposable Insulin Pen Needle2Cleared 510(K)
- K170988DropSafe Safety Pen Needle2Cleared 510(K)
- K170276Safety Blood Collection Device for Single Use2Cleared 510(K)
- K171984Clickfine Pen Needle, Penfine Classic Pen Needle2Cleared 510(K)
- K171144Medifine Pen Needle 3 Bevel, Medifine Pen Needle Quinta 5 Bevel2Cleared 510(K)
- K170768Mini Needle2Cleared 510(K)
- K161950Common Type Insulin Pen Needle, Safety Type Insulin Pen Needle2Cleared 510(K)
- K163093Safety Blood Collection Set2Cleared 510(K)
- K161255meso-relle (AAL34, AAL36, AM30G)2Cleared 510(K)
- K162516BD Pen Needle2Cleared 510(K)
- K160532Greiner Holdex2Cleared 510(K)
- K160199Advocate Insulin Pen Needles2Cleared 510(K)
- K151090CPL Insulin Pen Needle2Cleared 510(K)
- K160575CareSens Pen Needle, Softip Pen Needle2Cleared 510(K)
- K153706Insulin Pen Needle2Cleared 510(K)
- K160887Cook Intraosseous Infusion Needles2Cleared 510(K)
- K152166JSM Insulin Pen Needle2Cleared 510(K)
- K161553BD SafeAssist2Cleared 510(K)
- K152339Unifine Pentips/ Unifine Pentips Plus2Cleared 510(K)
- K160805NIO-P2Cleared 510(K)
- K152597ProteXsure Safety Capsule System2Cleared 510(K)
- K153388IMPROSAFE Blood Collection Set with Pre-attached Holder, IMPROVACUTER Blood Collection Set Pre-attached Holder, IMPROSAFE Blood Collection Set, IMPROVACUTER Blood Collection Set, IMPROSAFE Multi Sample Needle, IMPROSAFE Multi Sample Needle (Flashback), IMPROVACUTER Multi Sample Needle2Cleared 510(K)
- K152877SureFine Pen Needle2Cleared 510(K)
- K161170BD Eclipse Hypodermic Needle2Cleared 510(K)
- K152334Sungshim Insulin Pen Needle2Cleared 510(K)
- K152824MEDT PEN NEEDLE2Cleared 510(K)
- K152050Pencylcap2Cleared 510(K)
- K151311Safe Block Pen Needle2Cleared 510(K)
- K152410Top Fine Pen Needle2Cleared 510(K)
- K152514Clickfine AutoProtect Pen Needle2Cleared 510(K)
- K152183EXELINT SecureTouch Safety Hypodermic Needle2Cleared 510(K)
- K152362Terumo SurGuard 3 Safety Hypodermic Needle2Cleared 510(K)
- K151571Mini Needle2Cleared 510(K)
- K151341Turbo High-Flow Non-coring Needle2Cleared 510(K)
- K142765TM SAFETY NEEDLE2Cleared 510(K)
- K151398K-Pack II Needle - 29G x 5/16 Thin Wall2Cleared 510(K)
- K143437Droplet Pen Needles2Cleared 510(K)
- K150662Clickfine Pen Needle, Penfine Classic Pen Needle (other trade names anticipated)2Cleared 510(K)
- K150263K-Pack II Needle-21G x 22Cleared 510(K)
- K142086NIO -INTRAOSSEOUS DEVICE2Cleared 510(K)
- K140516Terumo Pen Injector Needle 342Cleared 510(K)
- K141749CAREFINE PEN NEEDLE FAMILY INCLUDING QUINTAPOINT AND SUPERPOINT2Cleared 510(K)
- K130097MEDMATE TRANSFER ADAPTER AM5500 & AM5500-NS2Cleared 510(K)
- K141117EZ-IO INTRAOSSEOUS INFUSION SYSTEM2Cleared 510(K)
- K133635EASYPOINT NEEDLE2Cleared 510(K)
- K132557EWNL SAFETY SYRINGE WITH NEEDLE2Cleared 510(K)
- K131954MEDI PEN NEEDLE2Cleared 510(K)
- K133738NOVOFINE PLUS 32G 4 MM2Cleared 510(K)
- K140568CAREFINE PEN NEEDLE WITH QUINTAPOINT AND SUPERPOINT2Cleared 510(K)
- K133059INSULIN PEN NEEDLE2Cleared 510(K)
- K133058INSULIN PEN NEEDLE2Cleared 510(K)
- K132583EZ-IO INTRAOSSEOUS INFUSION SYSTEM2Cleared 510(K)
- K133100CAREFINE PEN NEEDLE2Cleared 510(K)
- K130212SAFETY HYPODERMIC NEEDLES WITH/WITHOUT SYRINGE2Cleared 510(K)
- K132552U&U STERILE HYPODERMIC NEEDLE2Cleared 510(K)
- K132233K-PACK II NEEDLE - 27G X 3/4 THIN WALL2Cleared 510(K)
- K131842STERICAN CANNULA2Cleared 510(K)
- K131358BD PEN NEEDLE2Cleared 510(K)
- K131040EXTAVIPRO STERICAN 30G2Cleared 510(K)
- K131123CLICKFINE AUTOPROTECT PEN NEEDLE2Cleared 510(K)
- K131125CLICKFINE PEN NEEDLE2Cleared 510(K)
- K130487FASTRESPONDER STERNAL INTRAOSSEOUS DEVICE2Cleared 510(K)
- K123684SOL-CARE SAFETY NEEDLE2Cleared 510(K)
- K123300BD PEN NEEDLE2Cleared 510(K)
- K121607TERUMO(R) NEEDLE2Cleared 510(K)
- K122971CLICKFINE PEN NEEDLE2Cleared 510(K)
- K122969CLICKFINE PEN NEEDLE2Cleared 510(K)
- K120420STERILE BLUNT FOR SINGLE USE2Cleared 510(K)
- K113469NIPRO HUBER INFUSION, EXCEL HUBER NEEDLE2Cleared 510(K)
- K122249TERUMO SURGUARD3 SAFETY NEEDLE & HYPODERMIC SYRINGE WITH SAFETY NEEDLE2Cleared 510(K)
- K121632COMFORT EZ2Cleared 510(K)
- K121908SAFETY INFUSION SET2Cleared 510(K)
- K120690INSULIN PEN NEEDLE2Cleared 510(K)
- K120661THE T.A.L.O.N. INTRAOSSOUS INFUSION SYSTEM BY VIDACRE2Cleared 510(K)
- K120191PUSH-ON NEEDLE 30GX8MM2Cleared 510(K)
- K113186STERILE INSULIN PEN NEEDLE2Cleared 510(K)
- K113422TERUMO SURGUARD 3 SAFETY NEEDLE TERUMO SURGUARD 3 HYPODERMIC SYRINGE WITH SAFETY NEEDLE2Cleared 510(K)
- K112777SOL-M EXCHANGEABLE NEEDLES2Cleared 510(K)
- K113505VACUETTE QUICKSHIELD WITH SNAPPY TUBE HOLDER2Cleared 510(K)
- K110312CLICKFINE AUTOPROTECT PEN NEEDLE2Cleared 510(K)
- K112332FINE JECT INSULIN PEN NEEDLE2Cleared 510(K)
- K112789EASY TOUCH2Cleared 510(K)
- K110606MV INTRADERMIC NEEDLES; MAGIC NEEDLE; MAGIC NEEDLE2Cleared 510(K)
- K11179727 G X 1/2 K-PACK SURSHIELD NEEDLE2Cleared 510(K)
- K110656IMC BLOOD COLLECTION NEEDLE2Cleared 510(K)
- K111424VACUETTE PREMIUM SAFETY NEEDLE SYSTEM TUBE-TOUCH2Cleared 510(K)
- K110703BD AUTOSHIELD DUO PEN NEEDLE2Cleared 510(K)
- K110850K-PACK II NEEDLE- 27G & 30G THIN WALL2Cleared 510(K)
- K110527K-PACK SURSHIELD NEEDLE, HYPODERMIC NEEDLE FOR SINGLE USE2Cleared 510(K)
- K102328BLUNT FILL NEEDLE AND BLUNT PLASTIC CANNULA2Cleared 510(K)
- K110105BD PEN NEEDLE2Cleared 510(K)
- K103587DISPOSABLE BLLOD COLLECTION NEEDLE2Cleared 510(K)
- K102584IMC HYPODERMIC NEEDLE2Cleared 510(K)
- K102108CLICKFINE PEN NEEDLE2Cleared 510(K)
- K102010VACUETTE PREMIUM SAFETY BLOOD COLLECTION SET2Cleared 510(K)
- K102994K-SHIELD ARTERIAL VENOUS FISTULA SET WITH ANTINEEDLE STICK PROTECTOR2Cleared 510(K)
- K102774VACUETTE QUICKSHIELD WITH SNAPPY TUDE HOLDER2Cleared 510(K)
- K100124FASTX STERNAL INTRAOSSEOUS DEVICE2Cleared 510(K)
- K093043ZIRCONIA SYRINGE NEEDLE2Cleared 510(K)
- K101026POWERED PD-IO INFUSION SYSTEM, EZ-IO HUMERAL HEAD, POWERED PH-IO2Cleared 510(K)
- K093109NOVOTWIST NEEDLE, MODELS 30G * 8MM (1/3) 32 G TIP * 5 MM(1/5')2Cleared 510(K)
- K100812ULTICARE DISPOSABLE PEN NEEDLES2Cleared 510(K)
- K100436CLICKFINE PEN NEEDLE2Cleared 510(K)
- K100005BD PEN NEEDLE2Cleared 510(K)
- K100209BD ECLIPSE NEEDLE WITH SMARTSLIP TECHNOLOGY2Cleared 510(K)
- K092746MICRONJET 6002Cleared 510(K)
- K090111FLEXPEN NEEDLE2Cleared 510(K)
- K092831DISPOSABLE HYPODERMIC NEEDLE2Cleared 510(K)
- K091140EZ-MIO DISTAL TIBIA, EZ-IO DISTAL TIBIA, VIDAPORT INTRAOSSEOUS INFUSION SYSTEM, EZ-IO2Cleared 510(K)
- K092016SUPER-FINE PEN NEEDLE2Cleared 510(K)
- K090117AUTOSAFE-REFLEX SAFETY HUBER INFUSION SET, AUTOSAFE ADVANTAGE SAFETY HUBER INFUSION SET2Cleared 510(K)
- K090156ISOLYSER SHARPS ROOM SYSTEM, MODEL 800; ISOLYSER SHARPS MANAGEMENT SYSTEM, MODELS 2400, 4000, 100002Cleared 510(K)
- K090426VAKU-8 BLOOD COLLECTION NEEDLES2Cleared 510(K)
- K082908NOVAGUARD, MODEL 36110012Cleared 510(K)
- K082511MEDIGARD BLOOD COLLECTION DEVICE2Cleared 510(K)
- K082820K-PACK II NEEDLE - 29G THIN WALL2Cleared 510(K)
- K072602VACUETTE PREMIUM SAFETY NEEDLE SYSTEM2Cleared 510(K)
- K080904FEEL-FINE INSULIN PEN NEEDLE2Cleared 510(K)
- K080865FAST1 INTRAOSSEOUS INFUSION SYSTEM2Cleared 510(K)
- K080235SAFETY INFUSION SET2Cleared 510(K)
- K073705MODEL TW SB, SCALP VEIN SET; MODEL TW LB, STERILE HYPODERMIC NEEDLE2Cleared 510(K)
- K072487FAST1 INTRAOSSEOUS INFUSION SYSTEM2Cleared 510(K)
- K071307INVIROLINK AND INVIRO TIP BLUNT CANNULAS, MODEL 130001, 130501, 140001, 140002, 1400032Cleared 510(K)
- K073188HYPODERMIC NEEDLE-PRO EDGE SAFETY DEVICE2Cleared 510(K)
- K073257KAWASUMI LABORATORIES LARGE WING SETS WITH ANTINEEDLE STICK PROTECTOR2Cleared 510(K)
- K073127BLOOD COLLECTION NEEDLE, MODEL 20G 21G 22G2Cleared 510(K)
- K073122MONOJECT HYPODERMIC NEEDLE, MODEL 250, 30 GAUGE HYPODERMIC NEEDLE2Cleared 510(K)
- K072247STERICAN HYPODERMIC NEEDLES2Cleared 510(K)
- K072059GRIPPER MICRO NEEDLE2Cleared 510(K)
- K071947VACU-MED BLOOD COLLECTION NEEDLES2Cleared 510(K)
- K071998ARROW ECHOGENIC INTRODUCER NEEDLE COMPONENT2Cleared 510(K)
- K072320GREINER VACUETTE QUICKSHIELD COMPLETE2Cleared 510(K)
- K071567AUTOSAFE-REFLEX SAFETY NEEDLE, AUTOSAFE ADVANTAGE SAFETY NEEDLE2Cleared 510(K)
- K070988SC PROFI FINE PEN NEEDLE, MODELS; 5MM, 8MM, 12.7MM (28G, 29G, 30G, 31G)2Cleared 510(K)
- K071785HYPODERMIC NEEDLE-PRO EDGE SAFETY DEVICE, HYPODERMIC NEEDLE-PRO EDGE SAFETY DEVICE WITH SYRINGE2Cleared 510(K)
- K071088LIFE LATCH SHARPS & BIOHAZARD CONTAINER2Cleared 510(K)
- K070440BD HYPOINT NEEDLE2Cleared 510(K)
- K063466TOP FINE2Cleared 510(K)
- K063567EZ-MIO STERNAL2Cleared 510(K)
- K063450PORTEX HYPODERMIC NEEDLE- PRO EDGE SAFETY DEVICE, 18GX1, 401810, 19GX1, 401910, 20GX1,402010, 21GX14021102Cleared 510(K)
- K062940BONE INJECTION GUN (B.I.G.)2Cleared 510(K)
- K063142MANUAL PD-IO; POWERED PD-IO2Cleared 510(K)
- K062956EZ-MIO, EZ-IO DISTAL TIBIA2Cleared 510(K)
- K062500FLEXPEN NEEDLE2Cleared 510(K)
- K061933HAGER MIRAMATIC BOX SHARPS CONTAINER AND CAP TRAP NEEDLE RE-CAPPER2Cleared 510(K)
- K062984MEDLINE HYPODERMIC NEEDLES2Cleared 510(K)
- K062422HUMERAL HEAD, MANUAL DRIVER2Cleared 510(K)
- K06260829G AND 30G K-PACK II NEEDLE2Cleared 510(K)
- K061483VACUETTE VISIO PLUS BLOOD COLLECTION NEEDLES2Cleared 510(K)
- K061032DEPOTONE2Cleared 510(K)
- K052843BUSSE HOSPITAL DISPOSABLES NEEDLE STICK BLOCK/CUBE2Cleared 510(K)
- K060007BD AUTOSHIELD PEN NEEDLE2Cleared 510(K)
- K052725PROTECTOR NEEDLE SHEATH PROP2Cleared 510(K)
- K053470NOVOFINE 32G TIP2Cleared 510(K)
- K052445DUOPROSS NEEDLE2Cleared 510(K)
- K052561TERUMO MICRO TAPERED PEN NEEDLE2Cleared 510(K)
- K052408EZ-IO2Cleared 510(K)
- K052474NIPRO HYPODERMIC NEEDLE2Cleared 510(K)
- K052195EZ-MIO MANUAL DRIVER2Cleared 510(K)
- K051992POWERED PD-IO INTRAOSSEOUS INFUSION SYSTEM2Cleared 510(K)
- K051783ARTSANA PEN NEEDLES, ARTSANA INJECTION NEEDLES2Cleared 510(K)
- K051899BD PEN NEEDLE2Cleared 510(K)
- K043249ATRION NEEDLEVISE LARGE-BORE SHARPS SECURING DEVICE2Cleared 510(K)
- K050464ULTRACARE DISPOSABLE PEN NEEDLES, MODELS 31 GAUGE X3/16, 29 GAUGE X 1/22Cleared 510(K)
- K042917STAT MEDICAL PEN NEEDLE2Cleared 510(K)
- K050505DEPOTONE2Cleared 510(K)
- K050106NOVOFINE AUTOCOVER 30G X 8MM2Cleared 510(K)
- K043490PD-IO DISPOSABLE INTRAOSSEOUS INFUSION NEEDLE2Cleared 510(K)
- K043397MODIFICATION TO BD ECLIPSE HYPODERMIC NEEDLE2Cleared 510(K)
- K042907NEEDLE INCAPACITATOR (NEEDLE GUARD)2Cleared 510(K)
- K043019VASCULAR SOLUTIONS SCLERO-KIT2Cleared 510(K)
- K041941SAFE T RETRACTABLE BLOOD COLLECTION DEVICE2Cleared 510(K)
- K041399HYPODERMIC NEEDLE-PRO EDGE NEEDLE PROTECTION DEVICE2Cleared 510(K)
- K041153SHARPSAWAY II LOCKING DISPOSABLE CUP2Cleared 510(K)
- K040531TERUMO SURGUARD2 SAFETY NEEDLE2Cleared 510(K)
- K032885VIDAPORT INTRAOSSEOUS INFUSION SYSTEM2Cleared 510(K)
- K033575ONE.CLICK NEEDLE2Cleared 510(K)
- K032141SECUMAX BLOOD COLLECTION SYSTEM2Cleared 510(K)
- K033409AMERSHAM HEALTH NEEDLE-GUARD2Cleared 510(K)
- K033478VACUETTE QUICKSHIELD SAFETY TUBE HOLDER2Cleared 510(K)
- K033373MONOJECT INSULIN SYRINGE2Cleared 510(K)
- K031453TERUMO SURGUARD 2 SAFETY NEEDLE2Cleared 510(K)
- K031200MODIFICATION TO BD ULTRA-FINE III PEN NEEDLE2Cleared 510(K)
- K031058CORD STICK MULTIPLE DRAW SYSTEM2Cleared 510(K)
- K030032CROSSEAL APPLICATION DEVICE2Cleared 510(K)
- K024109BD ULTRA-FINE III PEN NEEDLE2Cleared 510(K)
- K022057KG MEDIX DISPOSABLE SYRING, 1,3,5,10, 20, 30, 50 ML'S,KG MEDIX2Cleared 510(K)
- K022415BONE INJECTION GUN (B.I.G.) FOR PEDIATRICS, MODEL 1ST2Cleared 510(K)
- K022406EXEL SECURETOUCH SAFETY VACULET BLOOD COLLECTION SET2Cleared 510(K)
- K021315SURE-LOK2Cleared 510(K)
- K021475BD SINGLE LUMEN NEEDLE, SYRINGE AND BLOOD COLLECTION SET2Cleared 510(K)
- K020921NO-POKES NEEDLE SAFETY DEVICE2Cleared 510(K)
- K011757EXEL COMFORTPOINT INSULIN PEN NEEDLE2Cleared 510(K)
- K013293NIPRO HYPODERMIC NEEDLE2Cleared 510(K)
- K013782DISETRONIC PENFINE INSULIN INJECTION PEN NEEDLE2Cleared 510(K)
- K012736MONOJECT SAFETY NEEDLE2Cleared 510(K)
- K012283SOLOGARD LOCKING PLUS SYRINGE WITH NEEDLE2Cleared 510(K)
- K002394JMS APHERESIS NEEDLE SET ACCORDION TYPE2Cleared 510(K)
- K011984BD VACUTAINER PUSH BUTTON BLOOD COLECTION SET2Cleared 510(K)
- K012646TERUMO 30 GAUGE HYPODERMIC NEEDLE2Cleared 510(K)
- K001853SYRINGE MANAGEMENT SYSTEM, MODEL SMS-12Cleared 510(K)
- K011925HYPODERMIC NEEDLE-PRO NEEDLE WITH NEEDLE PROTECTION DEVICE; HYPODERMIC NEEDLE-PRO SYRINGE & NEEDLE WITH NEEDLE PROTECTIO2Cleared 510(K)
- K011786VACUETTE SAFETY BLOOD COLLECTION SET2Cleared 510(K)
- K010887INSULIN PEN NEEDLE ADAPTER2Cleared 510(K)
- K011004NEEDLELOK HYPODERMIC NEEDLE PROTECTION2Cleared 510(K)
- K010958FISTULOK FISTULA NEEDLE PROTECTION2Cleared 510(K)
- K003812VACUETTE SPEEDY QUICK-RELEASE HOLDER2Cleared 510(K)
- K003381SHIELDING NEEDLE HOLDER2Cleared 510(K)
- K003521DISPO-MED 7.6 LITER SHARPS CONTAINER2Cleared 510(K)
- K003382SARSTEDT NEEDLE PROTECTOR2Cleared 510(K)
- K010188BD ECLIPSE HYPODERMIC NEEDLE2Cleared 510(K)
- K003627EXEL SECURE TOUCH SAFETY A.V. FISTULA NEEDLE SET2Cleared 510(K)
- K001965SAFE-POINT VAC, SAFE-POINT M-D BLOOD COLLECTION SYSTEMS2Cleared 510(K)
- K003461BD VACUTAINER PASSIVE SHIELDING BLOOD COLLECTION NEEDLE2Cleared 510(K)
- K010038NEEDLE BARN STICK STOPPER WITH SAFETY CAP, IN KIT WITH STERILE FIELD DRAPE2Cleared 510(K)
- K003406GUARDED NEEDLE 20002Cleared 510(K)
- K003827PUNCTUR-GUARD WINGED SET FOR BLOOD COLLECTION2Cleared 510(K)
- K000714VACUFLOW+SAFE BLOOD COLLECTION SET AND VACUFLOW+SAFE WITH HOLDER BLOOD COLLECTION SET2Cleared 510(K)
- K002403NOVOFINE 31 DISPOSABLE NEEDLE2Cleared 510(K)
- K002938B-D ULTRA-FINE III PEN NEEDLE; MODEL 31G X 3/162Cleared 510(K)
- K002180SIMPLICITY DISPOSABLE PEN NEEDLE2Cleared 510(K)
- K002213BULL'S-EYE DISPOSABLE NEEDLE RECAPPING AID2Cleared 510(K)
- K001175SERAGARD VASCULAR ACCESS PATCH2Cleared 510(K)
- K001572NEOLUS NEEDLE2Cleared 510(K)
- K001690PROTECTIV SAFETY BLOOD COLLECTION NEEDLE2Cleared 510(K)
- K993125SAFETYTIP MULTI-SAMPLE NEEDLE, SAFETYTIP BLOOD COLLECTION SYSTEM2Cleared 510(K)
- K001098PRO.DUCT HEALTH MICRO-STYLET, MODEL STY012Cleared 510(K)
- K000455GETTIG GUARD2Cleared 510(K)
- K000441BODYGUARD2Cleared 510(K)
- K000369VACUFLOW+ BLOOD COLLECTION SET, MODEL 52221/3/5; VACUFLOW+ WITH HOLDER BLOOD COLLECTION SET, MODEL 82021/3/5 WITH HOLDER2Cleared 510(K)
- K000085PORTSETT2Cleared 510(K)
- K000657LUER ACCESS UNIVERSAL VIAL ADAPTER2Cleared 510(K)
- K000387TERUMO NEEDLE WITH LOCKING SHEATH2Cleared 510(K)
- K992699NIPRO BLOOD COLLECTION NEEDLE2Cleared 510(K)
- K992729NIPRO LUER ADAPTOR2Cleared 510(K)
- K994197DISENTRONIC PENFINE INJECTION PEN NEEDLE2Cleared 510(K)
- K992626SURE-WAY REUSABLE SHARPS CONTAINER2Cleared 510(K)
- K992091PUNCTUR-GUARD REVOLUTION HOLDER, MODEL 47502Cleared 510(K)
- K991904MODIFICATION OF JMS NEEDLES AND JMS SYRINGES2Cleared 510(K)
- K984576K-PACK II (HYPODERMIC NEEDLE) 23G X 1, MODEL KN-2325RB, K-PACK II NEEDLE (HYPODERMIC NEEDLE) 25G X 1, MODEL KN-2525RB, K2Cleared 510(K)
- K990936THE VAULT2Cleared 510(K)
- K991404PLATYPUS AV FISTULA NEEDLE PROTECTOR (AVFNP)2Cleared 510(K)
- K990371DIABETIC NEEDLE DISPOSAL, MODEL # PMSM - 9502Cleared 510(K)
- K982029SHARPS COLLECTION CONTAINER - SAF-T-SHELL2Cleared 510(K)
- K983750DEROYAL INDUSTRIES, INC TRACECART SHARPS COLLECTION CONTAINER2Cleared 510(K)
- K981853BONE INJECTION GUN (B.I.G.) DEVICE2Cleared 510(K)
- K983067FINE-JECT2Cleared 510(K)
- K982541VACUTAINER BRAND ECLIPSE BLOOD COLLECTION NEEDLE, MODELS# 368607 & 3686082Cleared 510(K)
- K971924BLUNT SYRINGE CANNULA2Cleared 510(K)
- K982399DISETRONIC PENFINE INJECTION PEN NEEDLE2Cleared 510(K)
- K981619VACUETTE MULTIPLE SAMPLE LUER ADAPTER2Cleared 510(K)
- K972538FLOW-EZE BLUNT CANNULA (1999BC)2Cleared 510(K)
- K982097WORLDWIDE MEDICAL TECHNOLOGIES INTRACERVICAL BLOCK NEEDLE, MODEL TBD2Cleared 510(K)
- K981184SHARPTRACK REUSABLE SHARPS CONTAINER2Cleared 510(K)
- K974363BECTON DICKINSON BLUNT PLASTIC CANNULA2Cleared 510(K)
- K963658EXEL AVF SINGLE NEEDLE2Cleared 510(K)
- K972705RESHEATHER DEVICE-METAL OR PLASTIC, RESHEATER/ NEEDLE HOLDER DEVICE-PLASTIC2Cleared 510(K)
- K980227MANAN GALACTOGRAPHY KIT2Cleared 510(K)
- K980179SHARPS PLUS 5 GALLON SHARPS CONTAINER2Cleared 510(K)
- K980768VACUETTE HOLDEX2Cleared 510(K)
- K980062MONOJECTT BLUNTIP I.V. ACCESS CANNULA WITH VIAL ACCESS PIN DEVICE2Cleared 510(K)
- K980003M500-100 SHARPS CONTAINER2Cleared 510(K)
- K974006BECTON DICKINSON TWINPAK2Cleared 510(K)
- K973620VACUETTE MULTI-SAMPLE NEEDLE2Cleared 510(K)
- K973899UNIFINE PENTIPS2Cleared 510(K)
- K973012MDC SAFE STEP SAFETY BLOOD COLLECTION NEEDLE SYSTEM2Cleared 510(K)
- K9739112 GALLON ALTERNATE CARE SHARPS CONTAINER2Cleared 510(K)
- K973339DISETRONIC PENFINE INJECTION PEN NEEDLE2Cleared 510(K)
- K971487BKMI DISPOSABLE SYRINGE2Cleared 510(K)
- K972279SHARPS SHUTTLE2Cleared 510(K)
- K972469SELFSHIELD HN SELF SHEATHING HYPODERMIC NEEDLE2Cleared 510(K)
- K971763BLOOD COLLECTION TUBE HOLDER VANISHPOINT TUBE HOLDER/SMALL TUBE ADAPTER2Cleared 510(K)
- K972536SYRINGE NEEDLE REMOVER (S.N.R.)2Cleared 510(K)
- K970547ISOLYSER SDS SHARPS CONTAINER2Cleared 510(K)
- K970398SHARPS CONTAINER2Cleared 510(K)
- K970383SHARPS CONTAINER2Cleared 510(K)
- K964042EXTRESAFE PHLEBOTOMY2Cleared 510(K)
- K963748BIO-PLEXUS DROP-IT NEEDLE HOLDER2Cleared 510(K)
- K963571VYGON MULTI-DOSE VIAL ADAPTER & BIONECTOR2Cleared 510(K)
- K970380F.A.S.T. 1 INTRAOSSEOUS INFUSION SYSTEM2Cleared 510(K)
- K970370TSK STERIJEKT PREMIUM DISPOSABLE HYPODERMIC NEEDLE2Cleared 510(K)
- K964654BECTON DICKINSON BLUNT PLASTIC CANNULA2Cleared 510(K)
- K970737B-D ULTRA-FINE II SHORT 31G X 5/16 PEN NEEDLE2Cleared 510(K)
- K963351LIFESHIELD BLUNT CANNULA2Cleared 510(K)
- K965248BEMIS TWO GALLON SHARPS CONTAINER2Cleared 510(K)
- K963830SHARPS CONTAINER MODEL# SC0012Cleared 510(K)
- K962001MANAN PEDIATRIC BONE MARROW ACCESS NEEDLE2Cleared 510(K)
- K963595SERAGARD VASCULAR ACCESS DEVICE2Cleared 510(K)
- K960982MONOJECT BLUNT I.V. ACCESS CANNULA/MONOJECT HYPODERMIC SYRINGE WITH BLUNT I.V. ACCESS CANNULA2Cleared 510(K)
- K950686I.V. START KIT2Cleared 510(K)
- K962149SAFETY CRADLE2Cleared 510(K)
- K960933BIO-PLEXUS NEEDLE DISPOSAL CONTAINER2Cleared 510(K)
- K961877PISTON SYRINGE2Cleared 510(K)
- K955772CLINICARE STERILE DISPOSABLE SYRINGE/NEEDLES2Cleared 510(K)
- K961088NON-CORING NEEDLE2Cleared 510(K)
- K961878SHARPS-TAINER2Cleared 510(K)
- K961251PUNCTUR-GUARD WINGED SET2Cleared 510(K)
- K962035GE STERILE ARTHROGRAM TRAY2Cleared 510(K)
- K962040RNS ARTHROGRAM TRAY2Cleared 510(K)
- K961328BEC SHROUDED PLASTIC CANNULA2Cleared 510(K)
- K932889PERRY SPECIALTIES DESIGNS NEEDLE GUARD2Cleared 510(K)
- K960641RECAP-12Cleared 510(K)
- K960963CORD WRAP WITH NEEDLE RESHEATHER2Cleared 510(K)
- K960698NON-CORING NEEDLE2Cleared 510(K)
- K955748DOYLE EXTRACTOR2Cleared 510(K)
- K942073SHARPSPRO-TECTOR2Cleared 510(K)
- K952044INSULCAP2Cleared 510(K)
- K955235B-D ULTRA FINE II, MICRO FINE + SHORT NEEDLE INSULIN SYRINGE2Cleared 510(K)
- K952837DARWIN HYPODERMIC SAFETY SYSTEM (DHSS)2Cleared 510(K)
- K954500HOSPITEC MEDI-BUTLER2Cleared 510(K)
- K940645KEY-LOK(TM) SYSTEM2Cleared 510(K)
- K935916LIP GRIP CAP HOLDER2Cleared 510(K)
- K954041G.R.E.E.N. DISPOSAL CONTAINER (NOTE: G.R.E.E.N. IS AN ACRONYM FOR GLAXO RETRIEVAL EFFORT FOR EXPENDED NEEDLES)2Cleared 510(K)
- K951254SAFETYGLIDE NEEDLE2Cleared 510(K)
- K952834SHROUDED PLASTIC CANNULA2Cleared 510(K)
- K952274CHEMOGUARD, P2 HIRISK2Cleared 510(K)
- K944931BECTON DICKINSON BLUNT STEEL CANNULA2Cleared 510(K)
- K950012DISPOMEDIC DISPOSABLE SYRINGES AND NEEDLES2Cleared 510(K)
- K952518SAFE CAP NEEDLE RECAPPING/UNCAPPING DEVICE2Cleared 510(K)
- K934435CAP-STIK2Cleared 510(K)
- K943057CAP SAFE SYSTEM2Cleared 510(K)
- K946289DEVONS POINT LOK NEEDLE PROTECTION DEVICE2Cleared 510(K)
- K943765SHARPS AWAY2Cleared 510(K)
- K942930CAPCARD2Cleared 510(K)
- K951736LOCK-UP2Cleared 510(K)
- K950899LABORATORY SHARPS BARREL2Cleared 510(K)
- K946041CARDICO SHARPS CONTAINERS (1.5, 5, 9, 13, 21QTS.)2Cleared 510(K)
- K943626ISOLYSER SHARPS MANAGEMENT SYSTEM SMS2Cleared 510(K)
- K951515MONOJECT VERTICAL ENTRY CHEMOTHERAPY SHARPS CONTAINER2Cleared 510(K)
- K946084VANGUARD2Cleared 510(K)
- K950466B-D ULTRA-FINE II PEN NEEDLE2Cleared 510(K)
- K925056SAFESHARPE (TM) DISPOSAL SYSTEM2Cleared 510(K)
- K950159SURESHARP2Cleared 510(K)
- K945825SECURE SAFETY INSERT2Cleared 510(K)
- K945809MONOJECT(R) VERTICAL ENTRY SHARPS CONTAINER (1 QT)2Cleared 510(K)
- K943771MEDX REUSABLE SHARPS CONTAINER2Cleared 510(K)
- K944680SPLIT TOP WING NEEDLE CAP WITH OPTIONAL TUBING ANCHORS (AND APPROPRIATE RECAP DEVICE2Cleared 510(K)
- K944121SHARPS CONTAINER 18 GALLON2Cleared 510(K)
- K946027BIG PHIL2Cleared 510(K)
- K941031TOHP-CAP2Cleared 510(K)
- K944757PISTON SYRINGES2Cleared 510(K)
- K945284TRUJECT2Cleared 510(K)
- K945276PRO-TEC DISPOSABLE SHARPS CONTAINERS 5G2Cleared 510(K)
- K945273PRO-TECH DISPOSABLE SHARPS CONTAINERS VNC22Cleared 510(K)
- K945274PRO-TEC DISPOSABLE SHARPS CONTAINERS IR180 & IR802Cleared 510(K)
- K945275PRO-TEC DISPOSBLE SHARPS CONTAINERS Q12Cleared 510(K)
- K943794MX40002Cleared 510(K)
- K943740ROLL-A-WAY SHARPS DISPOSAL SYSTEM (RED AND IVORY)2Cleared 510(K)
- K943679UNIVEC NONRESUSABLE LOCKING SYRINGE2Cleared 510(K)
- K944114PHLEBOTOMY UNIT SHARPS A GATOR2Cleared 510(K)
- K943892POINT OF USE SHARPS A GATOR2Cleared 510(K)
- K942179PRO-TEC DISPOSABLE SHARPS CONTAINERS2Cleared 510(K)
- K943722CHEMOTHERAPY SHARPS DISPOSAL CONTAINERS2Cleared 510(K)
- K943139B-D GUARDIAN ONE PIECE SHARPS COLLECTORS2Cleared 510(K)
- K944230DIAL MEDICAL SUPPLY SHARPS CONTAINER2Cleared 510(K)
- K943135MED-SAFE INSULIN SHARPS CONTAINER2Cleared 510(K)
- K943134B-D GUARDIAN NESTABLE SHARPS COLLECTORS2Cleared 510(K)
- K943141B-D GUARDIAN POINT OF USE HORIZONTAL AND SIDE ENTRY SHARPS COLLECTORS2Cleared 510(K)
- K943140B-D GURADIAN CHEMOTHERAPY SHARPS COLLECTORS2Cleared 510(K)
- K943137B-D/BFI MAIL DISPOSAL SERVICE2Cleared 510(K)
- K943136B-D GUARDIAN POINT-OF-USE VERTICAL ENTRY SHARPS COLLECTORS2Cleared 510(K)
- K943683B-D SAFE-CLIP2Cleared 510(K)
- K943575B-D GUARDIAN NESTABLE SHARPS COLLECTORS2Cleared 510(K)
- K942901SHARPS-TAINER LARGE OPENING2Cleared 510(K)
- K942903SHARPS-TAINER SMALL OPENING2Cleared 510(K)
- K940961MONOJECT LUER ADAPTER2Cleared 510(K)
- K943485MONOJECT HORIZONTAL ENTRY SHARPS CONTAINER2Cleared 510(K)
- K943496MONOJECT TRAY SIZE SHARPS CONTAINER2Cleared 510(K)
- K942937SHARPSAFE CAT NO. 4105, 4115 AND 41202Cleared 510(K)
- K942624LOK-ON NEEDLE DISPOSAL CONTAINER2Cleared 510(K)
- K943578MONOJECT HIGH VOLUME/CHEMOTHERAPY SHARPS CONTAINER2Cleared 510(K)
- K942054SHARPS-TAINER2Cleared 510(K)
- K943594BAXTER ONE GALLON SHARPS DISPOSAL CONTAINERS2Cleared 510(K)
- K943605BAXTER TWO GALLON SHARPS DISPOSAL CONTAINERS2Cleared 510(K)
- K935407STICKIT2Cleared 510(K)
- K933601FLIPTIP SAFETY NEEDLE2Cleared 510(K)
- K942323ONGARD 2 GALLON SHARPS CONTAINER2Cleared 510(K)
- K935843BE-SAFE2Cleared 510(K)
- K933674ONGARD 2 GALLON CHEMO SHARPS CONTAINER2Cleared 510(K)
- K933274ONGARD 3 QUART SHARPS CONTAINER2Cleared 510(K)
- K925086AUTOMATIC NEEDLE DISCONECT (A.N.D.)2Cleared 510(K)
- K925816SHARPS CONTAINMENT SYSTEM2Cleared 510(K)
- K936235NEEDLESAFE II & NEEDLEGARD II2Cleared 510(K)
- K936261CATHETER INSERTION TRAY2Cleared 510(K)
- K935776SHARPSAFE, CAT. NO. 41262Cleared 510(K)
- K935777SHARPSAFE, CAT. NO. 41252Cleared 510(K)
- K930217BAXTER DISPOSABLE INTRAOSSEOUS INFUSION NEEDLE2Cleared 510(K)
- K934591CLAVE VIAL ACCESS SPIKE2Cleared 510(K)
- K933751LIFESHIELD BLOOD COLLECTION DEVICE2Cleared 510(K)
- K935514VACUUM TUBE HOLDER CULTURE MEDIUM VIAL HOLDER2Cleared 510(K)
- K936029NON-CORNING (HUBER) NEEDLE2Cleared 510(K)
- K935628SHARPSAFE CAT. NO. 41272Cleared 510(K)
- K934404MONOJECT VERTICAL ENTRY SHARPS CONTAINER2Cleared 510(K)
- K935506MULTI-SAMPLE LUER ADAPTER FOR BLOOD SAMPLE COLLECTION2Cleared 510(K)
- K935505WINGED COLLECTION SET W/MULTI-SAMPLE LUER ADAPTER2Cleared 510(K)
- K934088AUTO SUTURE SHARPS CONTAINER2Cleared 510(K)
- K935480MEDICAL SPECIALTIES NON-CORING NEEDLE ADMIN SETS2Cleared 510(K)
- K925234BEDSIDE CADDY2Cleared 510(K)
- K924793HAN-D-AID2Cleared 510(K)
- K931019BECTON DICKINSON LOCKING SAFETY-GARD(TM) IV NEEDLE2Cleared 510(K)
- K924820HYPOGRIP(TM)2Cleared 510(K)
- K925446BARD SAFE SAMPLING DEVICE2Cleared 510(K)
- K922179CATHETER INSERTION TRAY2Cleared 510(K)
- K921950SURGICAL DYNAMICS DISCOGRAPHY SYSTEM2Cleared 510(K)
- K923127NEEDLE-PRO CARTRIDGE2Cleared 510(K)
- K924070B-D PEN NEEDLE2Cleared 510(K)
- K924439BECTON DICKINSON INTERLINK VIAL ACCESS CANNULA2Cleared 510(K)
- K920737LIFESHIELD VIAL ADAPTER2Cleared 510(K)
- K922158PROTECTOR SYRINGE SAFETY CAP SYSTEM2Cleared 510(K)
- K920717NEEDLEGARD II2Cleared 510(K)
- K915409INTRAOSSEOUS ACCESS NEEDLE2Cleared 510(K)
- K913258DISPOSABLE INTROSSEOUS INFUSION NEEDLES2Cleared 510(K)
- K913386CHEMO-PORT2Cleared 510(K)
- K913885RINN E-Z CAPPER2Cleared 510(K)
- K913498MX927 BLOOD TRANSFER DEVICE2Cleared 510(K)
- K913317MEGA ARTHROGRAM KIT2Cleared 510(K)
- K913141MEGA MYELOGRAM KIT2Cleared 510(K)
- K913914PROGUARDII(TM) BLOOD COLLECTION DEVICE2Cleared 510(K)
- K910667STERI-STAT REUSABLE SYRINGE2Cleared 510(K)
- K913329V-ACCI-GUARD(TM) REUSABLE HOLDER2Cleared 510(K)
- K911597THE NEEDLE NABBER2Cleared 510(K)
- K911436SHARPS PIN CUSHION(TM) CONTAINER2Cleared 510(K)
- K910733MEDISYSTEMS ANTI-STICK INJECTION SITE NEEDLE2Cleared 510(K)
- K902422NEEDLE, ASPIRATION & INJECTION, DISPOSABLE2Cleared 510(K)
- K911037SAFETY NEEDLE SHEATH, MODIFICATION2Cleared 510(K)
- K905664VIAL ACCESS CANNULA2Cleared 510(K)
- K910455IMS DISPOSABLE HOLDER WITH NEEDLE RETRACTOR2Cleared 510(K)
- K905305SAFE-SITE NEEDLE COVER2Cleared 510(K)
- K904198SAFETY NEEDLE SHEATH2Cleared 510(K)
- K904107CAP-AID2Cleared 510(K)
- K903490NORPLANT(R) TROCAR2Cleared 510(K)
- K904295PROGUARD(TM) BLOOD COLLECTION NEEDLE2Cleared 510(K)
- K901162STERIMATIC(TM) SAFETY NEEDLE2Cleared 510(K)
- K895024PUNCTUR-GUARD(TM) BLOOD COLLECTION NEEDLE2Cleared 510(K)
- K895811SHARGHP HYPODERMIC NEEDLE2Cleared 510(K)
- K900282NEEDLE-SHIELD2Cleared 510(K)
- K895769EXEL HUBER NEEDLE2Cleared 510(K)
- K895771EXEL SPINAL NEEDLES2Cleared 510(K)
- K896293VIRAFREE CORP. EJECTABLE NEEDLE HOLDER2Cleared 510(K)
- K896320CENTURION KLEEN-NEEDLE SYSTEM2Cleared 510(K)
- K895630B-D PEND NEEDLE2Cleared 510(K)
- K895432SAFE-T-CAP2Cleared 510(K)
- K895075ACCI-GUARD REUSABLE HOLDER2Cleared 510(K)
- K895705SHAMROCK SAFETY BLOOD COLLECTION SET2Cleared 510(K)
- K894372NIPRO NEEDLE HOLDER2Cleared 510(K)
- K894374BLOOD DRAWING NEEDLE2Cleared 510(K)
- K890926SURECUT BMB BONE MARROW BIOPSY/ASPIRATION NEEDLE2Cleared 510(K)
- K891919INTRAVASCULAR ADMINISTRATION SET2Cleared 510(K)
- K890473NEEDLE GUARD(TM)2Cleared 510(K)
- K885122NEEDLE STICK2Cleared 510(K)
- K890620STICK-GARD SAFETY NEEDLE2Cleared 510(K)
- K890127INTRAVASCULAR ADMINISTRATION SET2Cleared 510(K)
- K884792VASCULAR ACCESS PORT HUBER POINT INFUSION NEEDLES2Cleared 510(K)
- K884620ASD SINGLE LUMEN NEEDLE2Cleared 510(K)
- K884212WINGED NON-CORING NEEDLE SET2Cleared 510(K)
- K884211STRAIGHT AND RIGHT ANGLE NON-CORING NEEDLES2Cleared 510(K)
- K884139ACCI-GUARD(TM) REGULAR AND PEDIATRIC HOLDER2Cleared 510(K)
- K883009NON-CORING NEEDLES2Cleared 510(K)
- K882880SAFETY, BLOOD COLLECTION TUBE HOLDER2Cleared 510(K)
- K882064LO-CORE NEEDLE2Cleared 510(K)
- K881654ACCI-GUARD MULTI-SAMPLE BLOOD COLLECTION NEEDLE2Cleared 510(K)
- K881671MANAN TABAR-ROTHSCHILD GALACTOGRAPHY KIT2Cleared 510(K)
- K881758VIGGO VASCUPORT NEEDLE2Cleared 510(K)
- K881785N.S. CADEE2Cleared 510(K)
- K880746STERILE NEEDLE FOR BLOOD COLLECTION2Cleared 510(K)
- K880892BLOOD COLLECTING NEEDLE AND HOLDERS2Cleared 510(K)
- K874602ASD-BIO ANTI-STICK DEVICE2Cleared 510(K)
- K874414HYPODERMIC NEEDLES, SINGLE LUMEN2Cleared 510(K)
- K874430NEEDLE CONTAINER2Cleared 510(K)
- K873991LAKE IRRIGATION TRAY2Cleared 510(K)
- K873165CHEMO-PORT NON-CORING NEEDLES2Cleared 510(K)
- K874024ACU-MICRO-NEEDLE2Cleared 510(K)
- K874372HR(TM) NEEDLE AND SYRINGE2Cleared 510(K)
- K874249BIFURCATED NEEDLE2Cleared 510(K)
- K873569BLOOD NEEDLE HOLDER2Cleared 510(K)
- K873957NON-CORING HUBER TYPE NEEDLES2Cleared 510(K)
- K872566MULTIPLE NEEDLE, INJECTION, DISPOSABLE2Cleared 510(K)
- K872580HR (TM) COLLECTION SYSTEM2Cleared 510(K)
- K871142ULTIMATE PROTECTIVE SAFETY CAP (UPS CAP)2Cleared 510(K)
- K870863FNA THYROID BIOPSY KIT2Cleared 510(K)
- K870193A+MED DISPOSABLE NEEDLE2Cleared 510(K)
- K862610ULTRA-VUE SPINAL TYPE BIOPSY NEEDLE2Cleared 510(K)
- K864310RYMCO STERILE SINGLE-USE NEEDLE/SINGLE USE SYRINGE2Cleared 510(K)
- K863606BUTTERFLY NON-CORING NEEDLE SET2Cleared 510(K)
- K863514PROMEDICOR2Cleared 510(K)
- K861390DEPTH MEASURING NEEDLES/VASCU IMPLANT ACCESS SET2Cleared 510(K)
- K861560MEDIPOINT MULTI-SAMPLE BLOOD COLLECTING NEEDLE2Cleared 510(K)
- K861406NON-KOR WINGED INFUSION SETS2Cleared 510(K)
- K861152EXEL VACUUM BLOOD COLLECTING SYSTEM2Cleared 510(K)
- K860781ICU MEDICAL NEEDLE, LOPEZ NEEDLE2Cleared 510(K)
- K861318DISPOSABLE NEEDLE COUNTER (20-720)2Cleared 510(K)
- K861081DISPOSABLE HYPODERMIC NEEDLE SAFETY SHEATH2Cleared 510(K)
- K852615R.R. AGHI HYPODERMIC SINGLE LUMEN NEEDLE2Cleared 510(K)
- K855248BLOOD COLLECTING NEEDLE2Cleared 510(K)
- K854547MONOJECT STERILE M200 ALUMINUM/M250 POLYPROPYLENE2Cleared 510(K)
- K854548MONOJECT STERILE M216 BLOOD COLLECTION NEEDLES2Cleared 510(K)
- K854549MONOJECT STERILE M400 PLASTIC&STERILE M401 ALUMINU2Cleared 510(K)
- K853604ACE-KYLE DYE INJECTION NEEDLE P/N 140822Cleared 510(K)
- K853731HEMED NEEDLE SUPPORT CATALOG NO. HAP-XXXX2Cleared 510(K)
- K852442PHARMA-PLAST NEEDLE2Cleared 510(K)
- K852831NON-KOR ACCESS KITS2Cleared 510(K)
- K851103VASCULAR IMPLANT ACCESS NEEDLE SET2Cleared 510(K)
- K845043JMS NEEDLES & JMS SYRINGES2Cleared 510(K)
- K850420CHURCHILL HABER POINT NEEDLE ADMIN. SET2Cleared 510(K)
- K844313INFUSET W/HUBER NEEDLE2Cleared 510(K)
- K843264MONOJECT MENGHINI SOFT TISSUE BIOPSY2Cleared 510(K)
- K844305GAINOR MEDICAL FLOWMAX NEEDLES2Cleared 510(K)
- K842542AMER. PHARMASEAL CHEMONUCLEOLYSIS TRAY2Cleared 510(K)
- K842756BUTTERFLY II PN INFUSION NEEDLE2Cleared 510(K)
- K841565HESUNG'S HYPERDERMIC NEEDLES2Cleared 510(K)
- K842012UMI CURVED CHEMONUCLEOLYSIS NEEDLE2Cleared 510(K)
- K841742NON-CORING NEEDLE2Cleared 510(K)
- K841704THINWALL PUNCTURE NEEDLE2Cleared 510(K)
- K841306HEPARIN LOCK FLUSH SOLUTION USP KIT,1002Cleared 510(K)
- K841305HEPARIN LOCK FLUSH SOLUTION USP KIT2Cleared 510(K)
- K841166HEPARIN LOCK FLUSH PROCEDURE PACK2Cleared 510(K)
- K833705BETAJECT BD U1002Cleared 510(K)
- K841577HYPODERMIC NEEDLES2Cleared 510(K)
- K841217PICKER MYELOGRAM TRAY-PMS MYELOGRAM2Cleared 510(K)
- K840944INFUSION NEEDLE IIPN2Cleared 510(K)
- K840334CHEMONUCLEOLYSIS/DISCOGRAPHY TRAY2Cleared 510(K)
- K840033HYPODERMIC NEEDLES & STYLETS2Cleared 510(K)
- K832904INTRAVENOUS NEEDLE2Cleared 510(K)
- K840967OHIO HEAT REFLECTING PATCH2Cleared 510(K)
- K834407STERILE DISPOSABLE SPINAL NEEDLES2Cleared 510(K)
- K834436CHEMONUCLEOLYSIS NEEDLE2Cleared 510(K)
- K834553INTRADISCAL THERAPY TRAY2Cleared 510(K)
- K830568GUTTMAN INFUSION NEEDLE2Cleared 510(K)
- K832858INTRADISCAL THERAPY TRAY2Cleared 510(K)
- K832556NEONATAL LUMBAR PUNCTURE TRAY2Cleared 510(K)
- K832102STERILE DISPOSABLE NEEDLES2Cleared 510(K)
- K831063BUTTON INFUSER2Cleared 510(K)
- K831395AVL 0073 MICROSAMPLER2Cleared 510(K)
- K831765HERAPIN LOCK FLUSH SOLUTION USE KIT2Cleared 510(K)
- K831610INTRADISCAL THERAPY NEEDLE2Cleared 510(K)
- K823899INFANT CARE SYSTEM2Cleared 510(K)
- K830242MICRO 2 HYPODERMIC NEEDLES2Cleared 510(K)
- K823693MYELOGRAPHY NEEDLE2Cleared 510(K)
- K823696MICRO Z BLOOD COLLECTING NEEDLES2Cleared 510(K)
- K823255NON-STERILE REUSABLE NEEDLES2Cleared 510(K)
- K821529DISPOSABLE HYPODERMIC NEEDLES2Cleared 510(K)
- K820911PBC NEEDLE BY NIPRO MED. INDUSTRIES2Cleared 510(K)
- K813256HYPODERMIC & SUTURE NEEDLES2Cleared 510(K)
- K813649PBC NEEDLE2Cleared 510(K)
- K813648JMS NEEDLE & MAC JECT2Cleared 510(K)
- K813545HYPOSERMIC NEEDLES2Cleared 510(K)
- K812910MEDISYSTEMS NEEDLES & SYRINGES2Cleared 510(K)
- K812404BUTTERFLY NEEDLE ASSEMBLY2Cleared 510(K)
- K811966VISITEC NEEDLE RANGE (GENERAL HOSPITAL)2Cleared 510(K)
- K801839DISPOSABLE HYPODERMIC NEEDLES2Cleared 510(K)
- K801431PAN-AM MYELOGRAM TRAY2Cleared 510(K)
- K801108DOUBLE ENDED VENTED TRANSFER DEVICE2Cleared 510(K)
- K801107DOUBLE ENDED FILTERED TRANSFER NEEDLE2Cleared 510(K)
- K7920962 FR KELMAN CHAMBER MAINTAINER2Cleared 510(K)
- K791462HYPERDERMIC NEEDLE WITH SENSOR #5142Cleared 510(K)
- K791156AMIPAQUE MYELOGRAM TRAY2Cleared 510(K)
- K790953BORDISPO BRAND HYPODERMIC NEEDLE2Cleared 510(K)
- K790086NEEDLE, TRUCARE VACUTAINER2Cleared 510(K)
- K780209DILUTION SPIKE2Cleared 510(K)
- K771667BLOOD GAS TRAY #40242Cleared 510(K)
- K771209TERUFUSION BLOOD ADMIN. SET2Cleared 510(K)
- K771203DISP. HYPODERMIC NEEDLE2Cleared 510(K)
- K771207TERUFUSION DONOR SET2Cleared 510(K)
- K770528NEEDLE, MEMBRANE2Cleared 510(K)
- K770425NEEDLES, STERILE, AIRWAY2Cleared 510(K)
- K770370CONVENIENCE TRAY2Cleared 510(K)
- K761098FILTER DEVICES2Cleared 510(K)
- K760780DOUBLE-ENDED NEEDLE2Cleared 510(K)
- 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
ProteXsure Safety Capsule System
- Page Type
- Cleared 510(K)
- 510(k) Number
- K152597
- 510(k) Type
- Traditional
- Applicant
- StarCap Medical LLC ( DBA Prism Medical & Design)
- Country
- United States
- FDA Decision
- Substantially Equivalent
- Decision Date
- 6/8/2016
- Days to Decision
- 271 days
- Submission Type
- Statement