Anesthesiology
Review Panel
- CardiovascularReview Panel
- ChemistryReview Panel
- DentalReview Panel
- Ear, Nose, ThroatReview Panel
- Gastroenterology and UrologyReview Panel
- General HospitalReview Panel
- 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
- MiscellaneousMiscellaneous
- MVFSystem, Laser, Photodynamic Therapy3Product Code
- MVGSystem, Laser, Fiber Optic, Photodynamic Therapy3Product Code
- MWZExpander, Breast, ExternalUProduct Code
- MYHSystem, Non-Coherent Light, Photodynamic Therapy3Product Code
- NBESealant, Polymerizing3Product Code
- PBDComposite Cultured SkinFProduct Code
- QPEPhototherapy Device For Reducing The Appearance Of Acute Post-Surgical Incisions2Product Code
- MTJWax, BoneUProduct Code
- DTHSuture, Cardiovascular3Product Code
- DZGSuture, Dental3Product Code
- EFQGauze/Sponge, InternalUProduct Code
- EYFProtector, Wound, PlasticUProduct Code
- FRODressing, Wound, DrugUProduct Code
- GELGauze/Sponge, Internal, With Drug/Biologic, Animal Source MaterialUProduct Code
- GERGauze, External (With Drug/Biologic/Animal Source Material)UProduct Code
- HMNSuture, Nonabsorable, Ophthalmic3Product Code
- HMOSuture, Absorbable, Ophthalmic3Product Code
- KGMSilicone, Liquid, Injectable3Product Code
- KGNDressing, Wound, CollagenUProduct Code
- LCJExpander, Skin, InflatableUProduct Code
- LFLInstrument, Ultrasonic SurgicalUProduct Code
- LMHImplant, Dermal, For Aesthetic Use3Product Code
- LMIImplant, Collagen For Non-Aesthetic Use3Product Code
- LRQTracheostomy And Nasal Suctioning Kit1Product Code
- LRRFirst Aid Kit With DrugNProduct Code
- LXULaser For Wound Healing3Product Code
- MAWMarker, Suture IdentificationUProduct Code
- MDDDevice, Dermal Replacement3Product Code
- MGPDressing, Wound And Burn, OcclusiveUProduct Code
- MGQDressing, Wound And Burn, Hydrogel W/Drug And/Or BiologicUProduct Code
- MGRDressing, Wound And Burn, Interactive3Product Code
- MQZProsthesis, NailUProduct Code
- MRDSizer, Mammary, Breast Implant VolumeUProduct Code
- MSADressing, Wound And Burn, Occlusive, HeatedUProduct Code
- NLQScalpel, Ultrasonic, ReprocessedUProduct Code
- NQKMaggots, MedicalUProduct Code
- NRNLeeches, MedicinalUProduct Code
- NSSElectronic Media, NauseaNProduct Code
- NZFStatic Electricity-Emitting Device, Cosmetic UseNProduct Code
- OCECultured Epithelial AutograftFProduct Code
- ODSWound Covering (Composite Cultured Skin)FProduct Code
- OEEDiagnostic Low Electric Field3Product Code
- OJIBurn Kit With DrugNProduct Code
- ONVElectrical Impedance Spectrometer3Product Code
- OYDOptical Diagnostic Device For Melanoma Detection3Product Code
- PFCCultured Human Cell Skin Dressing3Product Code
- PHUIntra-Abdominal Pressure Monitoring DeviceUProduct Code
- PKYImplant, Dermal, For Aesthetic Use In The Hands3Product Code
- PUVLymph Node Location System During Sentinel Biopsy Procedure3Product Code
- PZCAblation System, High Intensity Focus Ultrasound (Hifu), Soft TissueNProduct Code
- QOJApparatus, Suction, Operating-Room, Wall Vacuum Powered (Export Only)NProduct Code
- QQFSkin Microneedling Manual/Automated Device (Export Only)NProduct Code
- QVSBreast Implant Suction Retrieval Device2Product Code
- QVXSkin Patch For Treatment Of Hyperhidrosis2Product Code
- PLJTissue Adhesive Internal Use3Product Code
- QSXHemostatic Wound Dressing With Thrombin Or Other BiologicsUProduct Code
- QSYHemostatic Wound Dressing Without Thrombin Or Other BiologicsUProduct Code
- QSZAbsorbable Synthetic Wound DressingUProduct Code
- QGMFocused Ultrasound System For Non-Thermal, Mechanical Tissue Ablation2Product Code
- QZSSoftware-Aided Adjunctive Diagnostic Device For Use By Physicians On Lesions Suspicious For Skin Cancer2Product Code
- SABTable Mounted Miniaturized Electromechanical Surgical System2Product Code
- SAQElectromechanical System For Open Microsurgery2Product Code
- SAWFluorescence Imaging For Breast Cancer Detection3Product Code
- QMLAnal Fistula Closure Device2Product Code
- SAHMagnetic Compression Anastomosis System2Product Code
- QYKSemi-Automated Autologous Skin Graft Harvesting And Application Device2Product Code
- SCVModular Electromechanical Surgical System2Product Code
- SDDElectromechanical Surgical System Wherein The Surgeon Annd The User Interface Can Be In The Sterile Field2Product Code
- Submissions with No Product CodeMiscellaneous
- K943277LINK SADDLE PROTHESISCleared 510(K)
- K931488KSF SPINAL FIXATORCleared 510(K)
- K894336SURGICAL DYNAMICS DISCOGRAPHY SYSTEMCleared 510(K)
- K880539CART, MULTIPURPOSECleared 510(K)
- K880536CART, INSTRUMENTCleared 510(K)
- K872595HOLDING ROD, SURGICAL FORCEPS, WEINSTEIN,12X2 3/4Cleared 510(K)
- K871138FOUNDATIONS PLUS ABDOMINAL BAND 1100Cleared 510(K)
- K870894MEDSURG BONE MARROW BIOPSY/ASPIRATION TRAYCleared 510(K)
- K870744SURGICAL STARTER KITCleared 510(K)
- K870932SURGIFRESH SURGICAL SMOKE REMOVALCleared 510(K)
- P990075SALINE-FILLED MAMMARY PROSTHESIS - STYLES 5000 AND 5000PT AND SPECTRUM POST-OPERATIVELY ADJUSTABLE SALINE-FILLED MAMMARYAPPRPMA Approval
- P990075MENTOR SALINE-FILLED BREAST IMPLANTSAPPRPMA Approval
- P990075HIGH PROFILE ROUND SALINE-FILLED BREAST IMPLANT, STYLE 3000APPRPMA Approval
- P990075SALINE-FILLED MAMMARY PROSTHESIS AND SPECTRUM POST-OPERATIVELY ADJUSTABLE SALINE-FILLED MAMMARY PROSTHESISAPPRPMA Approval
- P990075MENTOR SALINE-FILLED MAMMARY PROSTHESESAPPRPMA Approval
- P990004SURGIFOAM ABSORBABLE GELATIN HEMORRHOIDECTOMY SPONGEAPPRPMA Approval
- P990004SURGIFORM ABSORBABLE GELATION SPONGE, USPAPPRPMA Approval
- P990004SURGIFOAM ABSORBABLE GELATIN SPONGE, USPAPPRPMA Approval
- P940011COHERENT PDL1 AND PDL2 LAMBDA PLUS PHOTODYNAMIC LASERSAPPRPMA Approval
- P940012600 SERIES DYE MODULES (MODELS 630 AND 630 XP) AND SERIES 700 AND 800 KTP/532 AND KTP/YAG SURGICAL LASERSAPPRPMA Approval
- P940011COHERENT PDL1 AND PDL2 LAMBDA PLUS PHOTODYNAMIC LASERSAPPRPMA Approval
- P940011COHERENT PDL1 AND PDL2 LAMBDA PLUS PHOTODYNAMIC LASERSAPPRPMA Approval
- P940012600 SERIES DYE MODULES (MODELS 630 AND 630 XP) AND SERIES 700 AND 800 KTP/532 AND KTP/YAG SURGICAL LASERSAPPRPMA Approval
- K870887WARD'S BREAST MEASURING DEVICECleared 510(K)
- K870764SCHUKNECHT WIRE CUTTING SCISSORSCleared 510(K)
- K870763SUPER SCISSORSCleared 510(K)
- K870760BUR BRUSHCleared 510(K)
- K870309WHITE PLUME ABSORBENT COTTON WOOLCleared 510(K)
- K870315WHITE PLUME ABSORBENT BANDAGECleared 510(K)
- K870306WHITE PLUME TRIANGULAR BANDAGECleared 510(K)
- K870284TRIANGULAR BANDAGECleared 510(K)
- K870257POREX(TM) SILICONE SURGICAL IMPLANTS FOR E.N.T.Cleared 510(K)
- K870182POREX(TM) MALAR IMPLANTCleared 510(K)
- K870156FLEXMEDICS NITINOL MAMMORY WIRECleared 510(K)
- K870059MENTOR NIPPLE RECONSTRUCTION DEVICECleared 510(K)
- K870105INFANT CAST TABLECleared 510(K)
- K870099PIVOTING SURGICAL ARM BOARDSCleared 510(K)
- K864935'EXMOOR' SHAH PACKING STRIPSCleared 510(K)
- K870044MCD SPECIALTY BRAND NEEDLE COUNTERSCleared 510(K)
- K864879OSI PAPOOSE BOARDCleared 510(K)
- K864923VACU-PREPCleared 510(K)
- K864689ALBA HEALTH CARE IODOFORM PACKING STRIPCleared 510(K)
- K864816CK 5000 SERIES, ACE BANDAGE/ESMARK BANDAGECleared 510(K)
- K864495MEDSURG VASCULAR ACCESS PORT INFUSION TRAYCleared 510(K)
- K864804CLOWARD DISPOSABLE ARMRESTS AND FACE RESTCleared 510(K)
- K864805CLOWARD SURGICAL SADDLECleared 510(K)
- K864824INFECTIOUS TISSUE KITCleared 510(K)
- K864596STERILITE STERILIZATION KITCleared 510(K)
- K864528TOWELSCleared 510(K)
- K864463MEDSURG CUSTOM SURGICAL SCRUB TRAYSCleared 510(K)
- K864693I.V. START KITSCleared 510(K)
- K864477FOUNDATIONS PLUS GIRDLE SUPPORT GARMENT 5000Cleared 510(K)
- K863931CARBONET ODOUR ADSORBING DRESSINGCleared 510(K)
- K863865TENSOTAPE SURGICAL ADHESIVE TAPECleared 510(K)
- K864023EYE PAD, COTTON, GAUZE COVEREDCleared 510(K)
- K864020ICE PICKCleared 510(K)
- K864018HACKSAWCleared 510(K)
- K864017SLOTTED PUNCHCleared 510(K)
- K863964LIMB-GUARDCleared 510(K)
- K863777B-WRAPCleared 510(K)
- K863774CONTOUR CUP MASKSCleared 510(K)
- K863754FOUNDATIONS PLUS FACIAL-CHIN-NECK SUPPORTER 1000Cleared 510(K)
- K863733TOWEL PACK, SURGICALCleared 510(K)
- K863721NORFOLK MEDICAL POSI-GRIP 'HUBER POINT' NEEDLECleared 510(K)
- K863690STAND, IRRIGATOR, STEEL, FOLDINGCleared 510(K)
- K863636UPDATED STERILE GENERAL HOSPITAL INSTRUMENTSCleared 510(K)
- K863557BLADE, SURGICAL PREPARATION RAZOR, STRAIGHT,SINGLECleared 510(K)
- K863604DISPOSABLE BLADES FOR ARTHROSCOPIC SURGICAL DEVICECleared 510(K)
- K863551MODIFIED MEDI-QUET TOURNIQUET, MODEL #2740-00Cleared 510(K)
- K863627MICRO SURGICAL DRILL SYSTEMCleared 510(K)
- K863563URESIL RADIOPAQUE SILICONE BANDSCleared 510(K)
- K863516ELECTRONIC METAL LOCATOR MODEL MD-1Cleared 510(K)
- K863194TENDERM TAPECleared 510(K)
- K863632UPDATED STERILE PROCEDURAL KITCleared 510(K)
- K863637UPDATED STERILE GOWNS, MASKS AND TOWELSCleared 510(K)
- K862972DISPOSABLE MIRRORCleared 510(K)
- K863284I.V. START KITCleared 510(K)
- K863283CARE + PLUS SUTURE REMOVAL TRAYCleared 510(K)
- K863336CORDIPAK ANGIOGRAPHY TRAYCleared 510(K)
- K863241LASER ASSISTED SURGICAL LAPAROSCOPY KITSCleared 510(K)
- K863279SURGI-TEK TUBE POSITIONERCleared 510(K)
- K863278SURGI-WIPESCleared 510(K)
- K863162VACU-GUARDCleared 510(K)
- K862213PRESSURE CONTROL VALVE & TUBING CAT. NO. 83-1010Cleared 510(K)
- K862961MODIFIED SURGICAL STARTER KITCleared 510(K)
- K862954LASER PLUME FILTERSCleared 510(K)
- K862922MICRO-AIRE CAST CUTTER BLADESCleared 510(K)
- K862851ALMORE FACE MASKCleared 510(K)
- K862804SPUNGUARD HOSPITAL COVERALLCleared 510(K)
- K862853SYRINGE INJECTION GUNCleared 510(K)
- K862731STA-SOF BREAST COMPRESSOR-CLAMPCleared 510(K)
- K861695SURGICAL PLASTERSCleared 510(K)
- K861527COMET COSMIC 203/218Cleared 510(K)
- K862582TREACE MEDICAL MICRO INSTRUMENT WIPECleared 510(K)
- K862335MODIFIED I.V. START, RE-START, PEDI AND GERI-KITCleared 510(K)
- K862583LITE TOUCH GELFOAM INSERTCleared 510(K)
- K861360MANIQUICK PEDICURE & MANICURE SETCleared 510(K)
- K862367PRO-CLEANCleared 510(K)
- K862219T.P.N. DRESSING CHANGE TRAYCleared 510(K)
- K862334CATALOG NO. I/A 100 AND KPE 200Cleared 510(K)
- K862111ARMBOARDS, REUSABLE AND DISPOSABLECleared 510(K)
- K861693MEDSURG CUSTOM DRESSING TRAYSCleared 510(K)
- K862039CONCORD CARE TRAYCleared 510(K)
- K861878BYRON SUCTION TIPSCleared 510(K)
- K862197RMP COMPANT CRICOTHYROTOMY EQUIPMENT STORAGE TRAYCleared 510(K)
- K861801WAXTREAT FCleared 510(K)
- K861800WAXTREAT BCleared 510(K)
- K861161SURGI-TIE LOOPSCleared 510(K)
- K861937AQUACEL SURGICAL PREP PADSCleared 510(K)
- K861952COMPOUND LEVERAGE SNIPCleared 510(K)
- K861954HEXAGONAL WRENCHESCleared 510(K)
- K861914TREACE MEDICAL FOAM INSTRUMENT PADCleared 510(K)
- K861803BRUSHINGCleared 510(K)
- K861804MEDCARE SUTURE REMOVAL KITCleared 510(K)
- K861589WECK-KREEM, CATALOG NO. 850-155Cleared 510(K)
- K861591WECK-LUBE, CATALOG NO. 850-150Cleared 510(K)
- K861784MEDSURG SINGLE USE BASIN SETCleared 510(K)
- K861198CUSTOM PROCEDURE KIT (VARIOUS SUB-TITLES)Cleared 510(K)
- K861453STAGNONE SWIVEL-JOINT NEEDLECleared 510(K)
- K861219ACCUPAC CUSTOM SKIN SCRUB KITCleared 510(K)
- K860763RADTECH VASCULAR STENTCleared 510(K)
- K860491OSTEO-MESH CRANIAL FAIRINGCleared 510(K)
- K854266STERILE LASER RESISTANT SURGICAL FIELD DRAPECleared 510(K)
- K860022PARAGON MICRO-LOOPSCleared 510(K)
- K860683MEDCARE EMERGENCY SHEARS/PUNCH & FIN TIPSCleared 510(K)
- K860506HARBOR MEDICAL RESPIRATORY TRAYCleared 510(K)
- K860507HARBOR MEDICAL DRESSING TRAYCleared 510(K)
- K860168UMI (FRANSEEN,WESTCOTT,GREENE,MENGHINI)BIO. NEEDLECleared 510(K)
- K860065SLUSH PAN COVERCleared 510(K)
- K860068FOOT PEDAL COVERCleared 510(K)
- K860067MICROSCOPE COLUMN DRAPECleared 510(K)
- K855160CARE IV BURN PAD, CATALOG #'S BP2334,BP3472Cleared 510(K)
- K854915PILLING DISPOSABLE AORTA PUNCHCleared 510(K)
- K854914PILLING IDENTILOOPSCleared 510(K)
- K854913MOBIN-VDDIN VEIN GRAFT HOLDERCleared 510(K)
- K854809WHITE CROSS STERILE PAD 4IN. X 4IN.Cleared 510(K)
- K854739AMERICAN STERILE SURGICAL ABSORBENT TOWELCleared 510(K)
- K854900EPISIOTOMY SCISSORSCleared 510(K)
- K854893KEYES SKIN PUNCHCleared 510(K)
- K854759AMERICAN STERILE MAYO STAND TRAYCleared 510(K)
- K854162SUPPORT ARMCleared 510(K)
- K854281MAGNETIC RETRIEVERCleared 510(K)
- K854462MIDAS REX SURGICAL RUBBER DAMCleared 510(K)
- K854068EXTERNAL MECHANICAL FASTENERCleared 510(K)
- K853759CUSTOM PROCEDURAL TRAY PROCEDURAL KITCleared 510(K)
- K854339CUI CHIN SIZERCleared 510(K)
- K854072JOHNS-ALLGOOD IRRIVAC DRIVE-IRRIGATOR/ASPIRATOR-Cleared 510(K)
- K854123MIDAS REX OPERATING ROOM VISECleared 510(K)
- K8532005X2 SATALEC CHIROPODY CASECleared 510(K)
- K853927LASE SYSTEM IICleared 510(K)
- K850803NAIL SPLINTCleared 510(K)
- K853847SUPER MICRO BLADESCleared 510(K)
- K853622SURE COUNT 30 COUNT FOAM & MAGNETIC 92-3030Cleared 510(K)
- K853829MENISCAL REPAIR SYSTEMCleared 510(K)
- K853801MENISCAL STITCHING KITCleared 510(K)
- K853623CHIBA, MADAYAG, POTTS-COURNAND, SELDINGER BIOPSY NCleared 510(K)
- K853839PENNINE LINK TUBINGCleared 510(K)
- K853800UPPER-CHEST-SUPPORT CUSHION FOR OPERATIONS IN SITTCleared 510(K)
- K853799NEUROSURGICAL HEADRESTCleared 510(K)
- K853798BONE IMPACTORSCleared 510(K)
- K853797KNEELING ATTACHMENT & CUSHIONED FACE REST SYS FORCleared 510(K)
- K853763TENDON STRIPPERCleared 510(K)
- K853659POWERED IRRIGATION FOR MICRO SURGICAL DRILLCleared 510(K)
- K853660MICRO SURGICAL DRILL SYSTEMCleared 510(K)
- K853559STERILE BIOPSY NEEDLESCleared 510(K)
- K853491REUSABLE DEXTRA SYNOVIAL RESECTORS IN 3.5/4.5/5.5MCleared 510(K)
- K853494REUSABLE END CUTTERS IN 3.5 & 4.2MM CONFIGUATIONCleared 510(K)
- K853493REUSABLE BULLET NOSE CUTTERS IN 3.5 & 4.2MM CONFIGCleared 510(K)
- K853492REUSABLE TRIMMER BLADES IN 3.5/4.2/5.5MM CONFIGUATCleared 510(K)
- K853490REUSABLE ABRADER TIPS IN 3.5MM & 5.5MM CONFIGUATIOCleared 510(K)
- K853558DOSIMETRIC RELEASE/RADIATION STERILIZ. ABSORB GAUZCleared 510(K)
- K853507STERI-GRIPCleared 510(K)
- K853495REUSABLE JACOBS DRILL CHUCKCleared 510(K)
- K853460ENDO L 300 LIGHT, ILLUMINATING WOUND RECTRACTORCleared 510(K)
- K853454SURE COUNT 5 & 10 SPONGE COUNTERCleared 510(K)
- K853374CORRECT-A-COUNTCleared 510(K)
- K853242I.V. START KIT, I.V. RESTART KIT, PEDI-KIT,GERI-KICleared 510(K)
- K853265ACCUPAC CUSTOM OPERATING ROOM PROCEDURE-DK876543Cleared 510(K)
- K853315CAUTERY TIP CLEANING PADCleared 510(K)
- K853286STAPLE REMOVERCleared 510(K)
- K853281EASYTOPCleared 510(K)
- K850945HUNTLEIGH FLOWTRON AIR HAND GARMENT, HG300Cleared 510(K)
- K850910HUNTLEIGH FLOWTRON AIR, AC400/2 AIRCleared 510(K)
- K852993BONE RONGEURSCleared 510(K)
- K853037DR. HESSEL'S VACUUM EXTRACTORCleared 510(K)
- K851495THORATEC MULTILUMEN CENTRAL VENOUS CATH-TRAYCleared 510(K)
- K844596EMERGENCY ROOM & MINOR OFFICE PROCEDURE CUSTOM KITCleared 510(K)
- K852859PENNINE CONNECTING TUBINGCleared 510(K)
- K852904ESTERIPAPEL BAGSCleared 510(K)
- K852891SPINAL FIXATION INSTRUMENTATION SYSTEMCleared 510(K)
- K852858STRETCH BANDAGECleared 510(K)
- K851651HGM ENDOCOAGULATOR MODEL 8Cleared 510(K)
- K852714MAYO DISSECTING SCISSORS, STRAIGHT, 5-1/2 + SSCleared 510(K)
- K852712MAYO SCISSORS, 6-3/4 CURVED SS 410 OR 420Cleared 510(K)
- K852734O.R. SCISSORS, STRAIGHT, 5-1/2+SHP/SHP SSCleared 510(K)
- K852732IRIS SCISSORS, CURVED, 4-1/2+SS 410 OR 420Cleared 510(K)
- K852719MAYO HEGAR NEEDLE HOLDER, G+SS 410 OR 420Cleared 510(K)
- K852731LISTER BANDAGE SCISSORS, 5-1/2+SS 410 OR 420Cleared 510(K)
- K852501MYELOGRAM PROCEDURE TRAYCleared 510(K)
- K852321SYLVANIA F8T5/PUVA & WALDMANN F15T8/PUVACleared 510(K)
- K852095ESP EMERGENCY CARE KITCleared 510(K)
- K852018ARTHROGRAM TRAY FOR DOUBLE & SINGLE CONTRAST ARTHRCleared 510(K)
- K852577RUBIN DISPOSABLE CARTILAGE PLANNERCleared 510(K)
- K852559BONE PIN CUTTER-18 INCHCleared 510(K)
- K852302INOX IORCEPS JARCleared 510(K)
- K852180SURGIDYNES VARIDYNE 350-2I & 350-2C CORDLESS ELEC.Cleared 510(K)
- K852555SPLINTREXCleared 510(K)
- K844142GORE-TEX TISSUE MATRIXCleared 510(K)
- K852258SURE-COUNT 30 COUNT MAGNETIC NEEDLE COUNTERCleared 510(K)
- K852245STILLE BONE CUTTING RORCEPS 10 1/4 IN SS 420 & 416Cleared 510(K)
- K852257SURE-COUNT 15 COUNT NEEDLE COUNTERCleared 510(K)
- K852154ACKRAD SIALOGRAPHY CATHETERCleared 510(K)
- K85176713-530 TO 13-542 VARIOUS IRIS SCISSORSCleared 510(K)
- K85176613-470 TO 13-518 VARIOUS UTERINE SCISSORSCleared 510(K)
- K85176513-440 TO 13-464 VARIOUS DISSECTING SCISSORSCleared 510(K)
- K85176413-340,13-350,13-360 LIGATURE SCISSORE SPENCER/LITCleared 510(K)
- K85176213-290 VARIOUS TONSIL SCISSORS-STRULLY, YANKAUER,Cleared 510(K)
- K85176113-280 NEURO SCISSORSCleared 510(K)
- K85176013-270 KILNER SCISSORSCleared 510(K)
- K85175913-260 TWO SIZES OF JOSEPH SCISSORSCleared 510(K)
- K85175813-224 TO 13-258 VARIOUS METZENBAUM SCISSORSCleared 510(K)
- K85175713-220 TOW TYPES OF LEXER SCISSORSCleared 510(K)
- K85175613-180 TO 13-212 VARIOUS MODELS OF MAYO SCISSORSCleared 510(K)
- K85175513-170 DEAVER SCISSOR, TWO SIZESCleared 510(K)
- K85175413-160 INCISION SCISSORS, TWO SIZESCleared 510(K)
- K85175313-100 TO 13-158 VARIOUS TYPES OF OPERATING SCISSOCleared 510(K)
- K85180371-100 TO 71-130 VARIOUS STERILIZING DRUMSCleared 510(K)
- K85178327-100 TO 27-180 VARIOUS PLASTER SCISSORS/SHEARSCleared 510(K)
- K85177823-130 TO 23-144 TWO TYPES OF DIRECTORSCleared 510(K)
- K85177723-100 TO 23-124 VARIOUS TYPES OF PROBESCleared 510(K)
- K852112SURGICAL STARTER KITCleared 510(K)
- K851489ARTERIAL-VENOUS COMPRESSION DRESSINGCleared 510(K)
- K843829K-MESHCleared 510(K)
- K850704RMC ASPIRATOR - VACUUM PUMPCleared 510(K)
- K851896DOUBLE ACTION PIN CUTTERCleared 510(K)
- K851852GENERAL HOSPITAL INSTRUMENTSCleared 510(K)
- K851882BANE CURVED RONGEUR, 7 SS TYPE 420Cleared 510(K)
- K851853STERILE GOWNS, MASKS & TOWELSCleared 510(K)
- K851701MANAN ZAVALA NEEDLECleared 510(K)
- K850764TAUCHER TUNNELER-PERIPHERAL VASCULAR SURG-INSTRUMECleared 510(K)
- K851656SHOULDER TRACTION KITCleared 510(K)
- K851312ABCO ISOLATION MASKSCleared 510(K)
- K851313ABCO SUTURE REMOVAL KITS-METAL & PLASTIC FORCEPSCleared 510(K)
- K851226I.V. START KITCleared 510(K)
- K851173ABCO TRAY CARE KITSCleared 510(K)
- K851109VOLKMAN RETRACTOR 704-8520 PCS. BLUNT-4 PRONG SS42Cleared 510(K)
- K851047PLASTIC TUBE EXTENTION SETCleared 510(K)
- K851022SINGLE LEG MAYFIELD TABLECleared 510(K)
- K850881ALBA DRY BURN PADCleared 510(K)
- K850246MASTER KIT ACleared 510(K)
- K850375MICROSURGERY VISIBILITY BACKGROUND MATERIALCleared 510(K)
- K844597MISCELLANEOUS GENERAL SURGICAL CUSTOM KITCleared 510(K)
- K850338EMERGENCY ROOM PACKCleared 510(K)
- K850266AMERICAN PHARMASEAL STERILE I.V. START KITCleared 510(K)
- K842356CUSTOM STERILE PROCEDURE KITSCleared 510(K)
- K844973IRRIGA SUC ILLUM ISIS 710 & 7100 SERIESCleared 510(K)
- K844923PERIMETER SUMP DRAINCleared 510(K)
- K844924PERIMETER YANKAUER SUCTION TIPS & SETSCleared 510(K)
- K844925PERIMETER MEDIASTINAL DRAINCleared 510(K)
- K844378OIL, MINERALCleared 510(K)
- K844377SILICONECleared 510(K)
- K850072CUSTOM OPEN HEART TRAYCleared 510(K)
- K850152PRECONNECTED URETHRAL CATHETER TRAYCleared 510(K)
- K850661MATRIX DRI-IDEA BOOTIESCleared 510(K)
- K8505953 X 4 NON-ADHERENT PADCleared 510(K)
- K850714C.A.D. PACK I -ARTHROSCOPY DRAPE PACKCleared 510(K)
- K850645INTRA-ARC DISPOSABLE ARTHROPLASTY BURRSCleared 510(K)
- K850501LISTER BANDAGE SCISSORS (6-0064)-4.5 500PCS.Cleared 510(K)
- K850502H/G CUP POSITIONER (1520) LEFT-500PCS RIGHT 500PCSCleared 510(K)
- K850500LISTER BANDAGE SCISSORS 6-0063(3,5 - 500 PCSCleared 510(K)
- K850251ROTALOK SURGICAL HAND TABLECleared 510(K)
- K850267SPARCO PIGGY-BACK POLE-INTRAVENOUS TRANSPORT POLECleared 510(K)
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- K850462CONCEPT CAMERA DRAPECleared 510(K)
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- K850041P-3 CLOSING INSTRUMENTCleared 510(K)
- K844788SOLEO SUNBEDCleared 510(K)
- K844832WETS & DRIESCleared 510(K)
- K850016TOWEL PACK, SURGICALCleared 510(K)
- K844052BIOBRANE BRAND TEMP. WOUND DRESSING W/ADHESIVECleared 510(K)
- K844609PERRY SUTURING SETCleared 510(K)
- K843885PERCUTANEOUS ASPIRATION BIOPSY TRAYCleared 510(K)
- K844757TUBING HOLDERCleared 510(K)
- K844599DIAGONAL PIN CUTTERCleared 510(K)
- K843884GENERAL UTILITY TRAY SYSTEMCleared 510(K)
- K843883STERILE PERCUTANEOUS TRANSHEPATIC CHOLANCleared 510(K)
- K844462DOSIMETRIC RELEASE IN THE PROCESSING OF GAMMA STERCleared 510(K)
- K843813INTRAVENOUS START KITCleared 510(K)
- K842404DRESSING CHANGE TRAY STERILE 5002Cleared 510(K)
- K844379STONE, INSTRUMENT HONINGCleared 510(K)
- K844320MANUAL SURGICAL INSTRUMENTS FOR GENERAL USECleared 510(K)
- K844147WIRE TWISTERSCleared 510(K)
- K844148PIN CUTTERCleared 510(K)
- K844073SEERAM BLADECleared 510(K)
- K844063SCISSORS GENERAL HOSPITALCleared 510(K)
- K844151SETS AND TRAYSCleared 510(K)
- K843543THE BIBICURE SYS DERMEPIL NATURAL HAIRCleared 510(K)
- K840362COMFEEL PASTECleared 510(K)
- K844072DERMIZIP SKIN CLOSURE DEVICECleared 510(K)
- K843525SUTURE TRAYCleared 510(K)
- K843499ARTHROSCOPY LEG HOLDERCleared 510(K)
- K843348NISONSON WIRE & DRILL GUIDE SYSCleared 510(K)
- K840547WILCOX ROD & PLATE BENDERCleared 510(K)
- K843721DISPOSABLE ISOLATION GOWNCleared 510(K)
- K842845BONE MILL BONE GRINDERCleared 510(K)
- K843562MSI SURGI-GRADE DELUXE CUT-DOWN TRAYCleared 510(K)
- K843559KLEENIT BY QMEDCleared 510(K)
- K842748SURGITEK RECONSTRUC-NIPPLE PROSTHESISCleared 510(K)
- K843312AUTO SUTURE SURGICLIP DISPOS. CLIP APPLCleared 510(K)
- K843257ANGIO SYS STERILE FIELD COVERCleared 510(K)
- K843258ANGIO SYS BRACHIAL ANGIO DRAPECleared 510(K)
- K843259ANGIO SYS FLUOROSCOPE DRAPECleared 510(K)
- K843006BARD-PARKER FLAT/ROUND SILICONE DRAINCleared 510(K)
- K843037DISPOSABLE LAPAROTOMY SPONGECleared 510(K)
- K842603OMED DISPOS. INSTRUMENT GUARDSCleared 510(K)
- K842860AMERICAN PHARMASEAL I.V. START KITCleared 510(K)
- K840152FERRIS VENT-A-DERMCleared 510(K)
- K841850CUSTOM STERILE PROCEDURE TRAYS-MULTICleared 510(K)
- K842254MEDICAL EMERG. STABILIZER OBJECT/BODYCleared 510(K)
- K843016VINYL EXAM GLOVES, NON-STERILECleared 510(K)
- K842255AIMED SCALP VEIN SET VARIOUSCleared 510(K)
- K842912THE SUTURERCleared 510(K)
- K842491SDC SILICONE FORCEP SHODS PRODUCTCleared 510(K)
- K842406WESCOTT TYPE BIOPSY NEEDLECleared 510(K)
- K842453DISPOSABLE PREPING PADCleared 510(K)
- K842438DISPOSABLE SURGERY HOODCleared 510(K)
- K842304THE PATHFINDERCleared 510(K)
- K841723ADLER CUSTOM PROCEDURE PACKSCleared 510(K)
- K842149PMS SUTURE PACK/TRAY;VERTEX SUTURECleared 510(K)
- K842091DISPOS. ACU-CUT SOFT TISSUE BIOPSYCleared 510(K)
- K841513SCANLAN ATRAUM INSTRUMENT JAW COVERCleared 510(K)
- K841669FLASH GUARDCleared 510(K)
- K841593AXIOM THORACIC CATHETERSCleared 510(K)
- K831531SURGICAL ISOLATION BARRIER SYSTEMCleared 510(K)
- K841952MULTI-PURPOSE TASK SUPPORT TABLECleared 510(K)
- K840498EXU-DRY BURN-TRAUMA DRESSING-VARIOUSCleared 510(K)
- K840555WALDMANN SUNTANNING EQUIP-MODELS'SCleared 510(K)
- K834577I/A PROBE LINESCleared 510(K)
- K841328SPC ARTHROSCOPY TABLECleared 510(K)
- K834093PERFORATOR BURCleared 510(K)
- K841505SURGI-MED TABLE MODEL 485-LTCleared 510(K)
- K841255BOUNDARY SINGLE-USE GOWNSCleared 510(K)
- K841037PENROSE DRAINSCleared 510(K)
- K840090VILENE SURGICAL MASK 5505Cleared 510(K)
- K834239SDI C-FLEX STERILE LIGHT HANDLECleared 510(K)
- K841283DISPOSABLE SUCTION TUBING SETCleared 510(K)
- K841086SURGICAL INSTRUMENT DEMAGNETIZERCleared 510(K)
- K834499SHEATHS FOR REINFORCING BONE CEMENTCleared 510(K)
- K834433PTCA BALLOON CATHETERS & ACCESS.Cleared 510(K)
- K833742ESCHMANN DILATION CATHETERCleared 510(K)
- K832482COMBO UVB/UVA TANNING BOOTHS 8-40-12-36Cleared 510(K)
- K834513FIXATION STAPLESCleared 510(K)
- K832551SHARPLAN #745 LASER SURG. UNITCleared 510(K)
- K833387ARGON LASER SURGICAL SYSTEM 770Cleared 510(K)
- K833997CO-SETCleared 510(K)
- K823234RADIATION STERILIZATION OF SURG. GLOVESCleared 510(K)
- K840401BIOPSY NEEDLES VARIOUSCleared 510(K)
- K840089SKIN STAPLE REMOVERCleared 510(K)
- K834339BOUNDARY REINFORCED SINGLE-USE GOWNSCleared 510(K)
- K840604DSP-200 DIGITAL STETHOSCOPECleared 510(K)
- K833856C-LOOPSCleared 510(K)
- K830635STERILE DISPOSABLE SURGICAL GLOVESCleared 510(K)
- K840378ADJUST-A-TEMP EXTRA FINE TIPCleared 510(K)
- K840374SURG-A-STAT FINE TIPCleared 510(K)
- K834186JAKOBI SURG. INSTRUMENTS #11Cleared 510(K)
- K833126DRESSING CHANGE TRAYSCleared 510(K)
- K833081ABSORABLE POLYGLACTIN 910-ANASTOMOTICCleared 510(K)
- K833325AMBULASE XAM-15 XANAR SURG. LASERCleared 510(K)
- K831936PRE-ROLLED TUBULAR STOCKINETTECleared 510(K)
- K832816HALL ARTHROTOMECleared 510(K)
- K832149PDM SILOXANE PROSTHETIC OBTURATORCleared 510(K)
- K832279PERIPHERAL TRANSLUMINAL ARGIOPLASTYCleared 510(K)
- K832848CHEMONUCLEOLYSIS TABLE #6100Cleared 510(K)
- K832525IRRIGATION/ASPIRATION PACKCleared 510(K)
- K831374MED CARE PREP RAZORCleared 510(K)
- K832118DIGIDENT ELEKTRONIC APEX LOCATORCleared 510(K)
- K831794SETS & TRAYSCleared 510(K)
- K832147CIRCUT 1Cleared 510(K)
- K832000THIGH HOLDERCleared 510(K)
- K831666SIALOGRAPHY NEEDLECleared 510(K)
- K831833MX CAMERACleared 510(K)
- K831832H-O CAMERACleared 510(K)
- K831520MORWEL CANNULACleared 510(K)
- K831230PULSE LAVAGECleared 510(K)
- K831068CONTAINER SYSTEMCleared 510(K)
- K830947SYRINGE/NEEDLE DISPOS-BOX-CUTTER/CRIMPERCleared 510(K)
- K830867REFLEX ONE STAPLE EXTRACTORCleared 510(K)
- K830522STAINLESS STEEL SUTURE 316LCleared 510(K)
- K823057MEDICATED ADHESIVE STRIPCleared 510(K)
- K823925CARTCleared 510(K)
- K830484OMED IDENT-I-BANDCleared 510(K)
- K830185UNIV. KNEE, CUTTING INSTRUMENTATIONCleared 510(K)
- K830143PNEUMATIC ANTERIOR CHAMBER MAINTAINERCleared 510(K)
- K823229SUTURE NEEDLESCleared 510(K)
- K823455SURGICAL GAUZECleared 510(K)
- K822755LATEX PENROSE TUBINGCleared 510(K)
- K823673LITE GUARDCleared 510(K)
- K822804OPERATING ROOM PROCEDURAL PACKCleared 510(K)
- K821702POWER SUTURECleared 510(K)
- K823492BIRT-A-PAD #730Cleared 510(K)
- K822713DERM-A-TEC SKIN BARRIER FILMCleared 510(K)
- K823400ARTHROSCOPIC LEG HOLDERCleared 510(K)
- K823391LEG PREP HOLDERCleared 510(K)
- K823398LATERAL POSITIONERCleared 510(K)
- K822900FISCH DRILL PUMPCleared 510(K)
- K822577OPERAND SUTURE REMOVAL TRAYCleared 510(K)
- K822747PILLING LACRIMAL INTUBATION SYSTEM(STER.Cleared 510(K)
- K822447SURGICARE MODEL 1000Cleared 510(K)
- K822439ACUFEX MAGNETIC RETRIEVERCleared 510(K)
- K822748PILLING COIN-STYLE BLADE GAUGECleared 510(K)
- K821723BI-4520 DUAL IMPEDOMETERCleared 510(K)
- K822554CEMENT EXTRACTION INSTRUMENTATIONCleared 510(K)
- K821797ACTISORB* ACTIVATED CHARCOAL CLOTH DRSG.Cleared 510(K)
- K821927TABLE, SURG. INSTRUMENT & DRESSINGCleared 510(K)
- K821850GALTEL-18Cleared 510(K)
- K821334OMED FABRIC INSTRUMENT COVERS-RADIOPAQCleared 510(K)
- K820682SURGICAL INSTRUMENTSCleared 510(K)
- K820443SURGI-SCRAPECleared 510(K)
- K820292EXTRACTOR IIICleared 510(K)
- K813081HISTOCAN BIOPSY NEEDLECleared 510(K)
- K812026K-MED SILICONE SUMP DRAINCleared 510(K)
- K812025K-MED SILICONE SUMP DRAIN W/ SHEATHCleared 510(K)
- K811279AFTERLOADING CATHETER SETCleared 510(K)
- K811960VISITEC NEDDLE TANGE (SURGERY)Cleared 510(K)
- K810689BALLOON CATHETERCleared 510(K)
- K811115SUPERFLOW CANNULA FOR ARTHROS. SURGERYCleared 510(K)
- K811287SKIN SCRUB TRAYCleared 510(K)
- K811166SURGICAL DRESSING SETCleared 510(K)
- K811157BLADE, TONGUECleared 510(K)
- K803154INSTRUMENT CLEANER LIQUID CONCENTRATECleared 510(K)
- K811060POLYETHYLENE MEDULLARY PLUGCleared 510(K)
- K810406STERILE WET DRESSING PACKCleared 510(K)
- K802851GARDNER KUPHOSIS DISTRACTORCleared 510(K)
- K810150OMNISURG WORKING INSTRUMENT TABLECleared 510(K)
- K802868ACCU-COUNTER SURGICAL SPONGE COUNTING SYCleared 510(K)
- K801175SILASTIC II MAMMARY IMPLANTCleared 510(K)
- K802671EMPTY TRANSFER BAGSCleared 510(K)
- K801310THE MAGTEC SYSTEMCleared 510(K)
- K801292SURGICAL INSTRUMENTSCleared 510(K)
- K801312THE PROTECTORSCleared 510(K)
- K792556NASO STENTCleared 510(K)
- K792608TEGTMEIER MAMMOMETERCleared 510(K)
- K792386NUTRA-PH INSTRUMENT MILKCleared 510(K)
- K792330XOMED MICROSURGERY BACKGROUNDCleared 510(K)
- K791184BIOBRANE BRAND TEMPORARY WOUND DRESSINGCleared 510(K)
- K791192AF/SYSTEMCleared 510(K)
- K791494VACUTOME SUCTION UNITCleared 510(K)
- K791509AXIOM GASTRO SUMP DRAINCleared 510(K)
- K791508AXIOM FILTERED CONNECTORCleared 510(K)
- K791221TEGTMEIER MAMMOMETERCleared 510(K)
- K782154COLOSTOMY DEVICE, MACLET MAGNETICCleared 510(K)
- K790871ENCLOSED CASE CARTCleared 510(K)
- K790245STANDARD PECTORALIS MUSCLE IMPLANTCleared 510(K)
- K790331ZIMMER SURGICAL INSTRUMENT LUBRICANTCleared 510(K)
- K790247TOURNIQUET TEST GAGECleared 510(K)
- K782120SPONGE SYSTEM, ROSERING CONTAIN-COUNTCleared 510(K)
- K781866CANNULA CADDYCleared 510(K)
- K781672ACU-DOTCleared 510(K)
- K781547MICROSURGURY VISIBILITY BACKGROUNDCleared 510(K)
- K780990STAINLESS STEEL TEMPLATECleared 510(K)
- K780478LIQUID CRYSTAL THERMOGRAPHIC SYSTEMCleared 510(K)
- K780310DERMATRON IONTOPHORESIS DEVICECleared 510(K)
- K780258MILK BATH CONCENTRATECleared 510(K)
- K780610INSTRUMENT LUBRICANTCleared 510(K)
- K771785IRRIGATING NEEDLE, ILLUMINATEDCleared 510(K)
- K770698COUNTER, SPONGECleared 510(K)
- K761141ARTERIAL GRAFT SIZERSCleared 510(K)
- K760902BARRIER UNDER BUTTOCKS DRAPECleared 510(K)
- K760309LIMB HOLDER, TECNOL REMINDERCleared 510(K)
- Subpart B—Diagnostic DevicesCFR Sub-Part
- Subpart C—General Hospital and Personal Use Monitoring DevicesCFR Sub-Part
- Subpart D—Prosthetic DevicesCFR Sub-Part
- Subpart E—Neurological Surgical DevicesCFR Sub-Part
- Subpart E—Surgical DevicesCFR Sub-Part
- Subpart F—General Hospital and Personal Use Therapeutic DevicesCFR Sub-Part
- Subpart F—Physical Medicine Therapeutic DevicesCFR Sub-Part
- Subpart F—Therapeutic DevicesCFR Sub-Part
- ToxicologyReview Panel
- Medical GeneticsReview Panel
- UnknownReview Panel
600 SERIES DYE MODULES (MODELS 630 AND 630 XP) AND SERIES 700 AND 800 KTP/532 AND KTP/YAG SURGICAL LASERS
- Page Type
- PMA Approval
- FDA Hosted PDF* The FDA doesn't provide PDFs for all submissions.
- Applicant
- AMERICAN MEDICAL SYSTEMS, INC.
- Trade Name
- 600 SERIES DYE MODULES (MODELS 630 AND 630 XP) AND SERIES 700 AND 800 KTP/532 AND KTP/YAG SURGICAL LASERS
- Generic Name
- SYSTEM, LASER, PHOTODYNAMIC THERAPY
- Decision Date
- 12/27/1995
- Days to Decision
- 623 days
- Decision Code
- APWD
- FDA Decision
- Withdrawal after approval