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
- K991757NON-ABSORBABLE GAUZE FOR EXTERNAL USE, STERILE AND NON STERILEUCleared 510(K)
- K991215SYMTEX GAUZE PADS (1'S) AND SYMTEX GAUZE SPONGES STERILE 2'S AND STERILE 10'SUCleared 510(K)
- K990974VITOP DRESSINGUCleared 510(K)
- K990584GAUZE SPONGES: LAPAROTOMY SPONGE, X-RAY DETECTABLEUCleared 510(K)
- K984187CROSSTEX NON-WOVEN SPONGESUCleared 510(K)
- K983016GAUZE, SPONGES, CAT # 11-003UCleared 510(K)
- K983348DYNAREX TRACHEOSTOMY SPONGEUCleared 510(K)
- K983450STARRYSHINE GAUZE SPONGEUCleared 510(K)
- K982648JOAN IIUCleared 510(K)
- K980791DUMEX PAK-ITS WOVEN RIBBON PACKINGUCleared 510(K)
- K974316HYDROFERA FEMORAL WICKUCleared 510(K)
- K974347BALDUR NON-STERILE COTTON SPONGESUCleared 510(K)
- K973763KENDALL CURITY IODOFORM PACKING STRIPUCleared 510(K)
- K973580INVOTEC CLEAN PADUCleared 510(K)
- K973299PIN CARE KITUCleared 510(K)
- K971088OPPORTUNITY INCISION AND DRAINAGE TRAYUCleared 510(K)
- K971095OPPORTUNITY SUTURE REMOVAL KITUCleared 510(K)
- K971178RAND SURGICAL SPONGEUCleared 510(K)
- K971075PRIMED PRIME-PLUS COTTON GAUZE SPONGESUCleared 510(K)
- K970455DUKAL NON ADHERENT DRESSINGUCleared 510(K)
- K970457DUKAL ABD COMBINE PADUCleared 510(K)
- K970020SIMAR, INC. SURGICAL DRESSINGUCleared 510(K)
- K963724GAUZE SPONGE, NON X-RAY DETECTABLEUCleared 510(K)
- K960615GAUZE COMPRESSUCleared 510(K)
- K963188DRAIN/SLIT SPONGE (NON-STERILE AND STERILE)UCleared 510(K)
- K962972SURGICADE GAUZE SPONGEUCleared 510(K)
- K963134DRAIN/SLIT SPONGE (NON-STERILE AND STERILE)UCleared 510(K)
- K962227PRO-FECT STERILE GAUZE SPONGESUCleared 510(K)
- K961773PROTEC STERILE GAUZE SPONGEUCleared 510(K)
- K961775PROFORE FOUR-LAYER BANDAGE SYSTEM KITUCleared 510(K)
- K962234STERILE GAUZE SPONGE - PICK-UPS 12PLY (GS-412), PICK-UPS 16PLY (GS-416)UCleared 510(K)
- K961061CODI SYNTHETIC SPONGE(NON-STERILE AND STERILE)UCleared 510(K)
- K961581EMERALD STERILE GAUZE SPONGEUCleared 510(K)
- K960523NHMC DRESSING TRAYUCleared 510(K)
- K960388DYNAREX NON-WOVEN SPONGEUCleared 510(K)
- K960093PROTEC ROLL GAUZEUCleared 510(K)
- K955527GENERAL USE SYNTHETIC SPONGE (STERILE)UCleared 510(K)
- K955165SYNTHETIC SPONGEUCleared 510(K)
- K955321PROTEC GAUZE SPONGEUCleared 510(K)
- K953914KENTEXUCleared 510(K)
- K953810FLUFF GAUZE BANDAGE, STERILE & NON-STERILEUCleared 510(K)
- K953072MEROCEL VAGINAL PACKUCleared 510(K)
- K953501ADI STERILE GAUZE SPONGESUCleared 510(K)
- K950906LESINSKI SURGICAL EAR DRESSINGUCleared 510(K)
- K950258HEMO-BARRIER TOURNIQUETUCleared 510(K)
- K951660DYNAREX GAUZE SPONGEUCleared 510(K)
- K950404LOCKETT MEDICAL CORP. GAUZEUCleared 510(K)
- K951418LORREX GAUZE PADS (1'S) AND LORREX GAUZE SPONGES - STERILE 2'S AND STERILE 10'S AND NON-STERILEUCleared 510(K)
- K950462GAUZE, NONABSORABLE, NON-MEDICATED (INTERNAL SPONGE)UCleared 510(K)
- K9450042, 3 & 4 BANDADGE COMPRESSUCleared 510(K)
- K9450021X6YD, 2X6YD, 4X6YD ROLL BANDAGEUCleared 510(K)
- K946326DUTEX GAUZE BANDAGEUCleared 510(K)
- K945960LORREX NON-WOVEN SPONGES NON-STERILE, STERILE, DRESSINGSUCleared 510(K)
- K945830DUFLEX CONFORMING BANDAGE (STERILE/NON-STERILE)UCleared 510(K)
- K945021FLUFF GAUZE SPONGEUCleared 510(K)
- K945020FLUFF GAUZE SPONGEUCleared 510(K)
- K945019FLUFF GAUXZE ROLLUCleared 510(K)
- K940765ISOLYSERUCleared 510(K)
- K940716OREXUCleared 510(K)
- K941099CLEAN-SORBUCleared 510(K)
- K943339GAUZE SPONGE (E.W.A. LTD./VARIOUS)UCleared 510(K)
- K943184LORREX HEALTH PROD COTTON FILLED SPONGES STERILE 2'SUCleared 510(K)
- K942824LORREX IV SPONGES, STERILE 2'S; LORREX DRAIN SPONGES, STERILE 2'SUCleared 510(K)
- K942692LORREX HEALTH PRODUCTS-FLUFF GAUZE ROLLS; GAUZE CONFORMING BANDAGES STERILE AND NON STERILEUCleared 510(K)
- K942691LORREX POST OPERATIVE SPONGESUCleared 510(K)
- K941649SURGICAL SPONGEUCleared 510(K)
- K942314LORREX GAUZE SPONGES SPECIALTYUCleared 510(K)
- K941455STERILE GAUZE PRODUCT LINEUCleared 510(K)
- K942106SUPER/FLUFF SPONGESUCleared 510(K)
- K942071LORREX NON-WOVEN SPONGES NON-STERILEUCleared 510(K)
- K942070LORREX COVER SPONGES STERILE2'S AND NON-STERILEUCleared 510(K)
- K941956LORREX GAUZE PADSUCleared 510(K)
- K941955LOREX TRACHEOSTOMY GAUZE SPONGES - STERILE 1'S AND 2'SUCleared 510(K)
- K940754ISOLYER (4X4, 12 PLY)UCleared 510(K)
- K940574TENDERBREDE(R) PACKING AND DEBRIDEMENT SPONGEUCleared 510(K)
- K940904KITTNER DISSECTOR/PEANUT/CHERRY/STICK/TRIANGLE SPONGE/GAUZE ROSEBUDUCleared 510(K)
- K940692PLAIN GAUZE DRESSINGUCleared 510(K)
- K935257MEDICOM NON-WOVEN SPONGESUCleared 510(K)
- K940901NON-WOVEN SPONGEUCleared 510(K)
- K940358X-LARGE MULTI-FUNCTION TRAUMA DRESSINGUCleared 510(K)
- K940440DUKAL NON-WOVEN GAUZEUCleared 510(K)
- K936216STERILE GAUZE SPONGESUCleared 510(K)
- K940210VISITEC EYE PADUCleared 510(K)
- K940076DERMASSIST WET DRESSING, WATERUCleared 510(K)
- K940044DERMASSIST WET DRESSING, SALINEUCleared 510(K)
- K936230DERMASSIST PETROLATUM GAUZE,USPUCleared 510(K)
- K936234DERMASSIST OIL EMULSION NON-ADHERING WOUND DRESSINGUCleared 510(K)
- K940339IODOFORM PACKAGING STRIPUCleared 510(K)
- K940348TRAUMA PAD 5 X 9UCleared 510(K)
- K940351EXTRA LARGE COMPRESS DRESSINGUCleared 510(K)
- K9403448 X 10 NON-STICK PADUCleared 510(K)
- K940345TRIANGULAR BANDAGEUCleared 510(K)
- K935930NON ADHERENT DRESSING AND NON ADHERENT DRAIN DRESSINGUCleared 510(K)
- K936095GAUZE SPONGEUCleared 510(K)
- K935934NON ADHERANT BURN PADSUCleared 510(K)
- K935911PACKING SPONGEUCleared 510(K)
- K935241GAUZE DRESSINGUCleared 510(K)
- K935938BANDAGE ROLLS, STRETCH GAUZE ROLLS, TEXTURED GAUZE ROLLSUCleared 510(K)
- K935937POST OP SPONGEUCleared 510(K)
- K935936CONFORMING ROLLUCleared 510(K)
- K935935BURN GAUZE PADSUCleared 510(K)
- K935939GAUZE FLUFFUCleared 510(K)
- K935933CUSTOM BURN DRESSINGUCleared 510(K)
- K935932BURN COMPRESSUCleared 510(K)
- K935931NON-WOVEN SPONGEUCleared 510(K)
- K935940GAUZE SPONGE; DRAIN SPONGEUCleared 510(K)
- K935941READY CUT GAUZE GAUZE BOLTSUCleared 510(K)
- K935942SURGICAL LAPAROTOMY SPONGE X-RAY DETECTABLEUCleared 510(K)
- K933308DYNAREX GAUZE SPONGE OR PADSUCleared 510(K)
- K933159XYZ PADSUCleared 510(K)
- K921983NU-BREDE PACKING AND DEBRIDEMENT SPONGEUCleared 510(K)
- K923041INTESTINAL SPONGESUCleared 510(K)
- K922055STERILE AND NON-STERILE GAUZE SPONGESUCleared 510(K)
- K905068PTI INTRA-ART (TM) PICK-UP WICKSUCleared 510(K)
- K912955EYE PADUCleared 510(K)
- K910623GAUZE SPONGES ABSORBENT GAUZE ROLLSUCleared 510(K)
- K905136GAUZE SPONGES, INTERNAL AND EXTERNALUCleared 510(K)
- K897180MEDI-SURE, MEDI-SORBUCleared 510(K)
- K896801LAP SPONGEUCleared 510(K)
- K895865SERENE WRAPUCleared 510(K)
- K896490CURITY(R) DISPOSABLE LAPAROTOMY SPONGESUCleared 510(K)
- K895086GAUZE SPONGEUCleared 510(K)
- K894505COTOLIN DRAIN SPONGE AND DRESSING SPONGEUCleared 510(K)
- K8939024 X 4 STERILE GAUZE SPONGE TRAYUCleared 510(K)
- K891460NON-ABSORB GAUZE SURG SPONGE & WOUND DRESS/EXT USEUCleared 510(K)
- K890770STERILE LAPAROTOMY SPONGESUCleared 510(K)
- K890727NON-STERILE, BULK GAUZE SPONGESUCleared 510(K)
- K885143ABSORBENT GAUZE ROLLUCleared 510(K)
- K885142GAUZE SWABS, NON-STERILEUCleared 510(K)
- K884826GAUZE SPONGEUCleared 510(K)
- K882021PRO-FECT LAPAROTOMY SPONGESUCleared 510(K)
- K882712STICK SPONGEUCleared 510(K)
- K882711GAUZE SPONGE 12PLYUCleared 510(K)
- K882710INTESTINAL SPONGESUCleared 510(K)
- K882530TAPE STRUNG TONSIL SPONGEUCleared 510(K)
- K882529BUTCHER STRUNG TONSIL SPONGEUCleared 510(K)
- K882528CYLINDRICAL SPONGEUCleared 510(K)
- K882527GAUZE SPONGEUCleared 510(K)
- K881395GAUZE AND LAP SPONGES -STERILE & NON-STERILEUCleared 510(K)
- K880208INVESTIGATION KIT, SEXUAL ASSAULT DETERMINATIONUCleared 510(K)
- K881222JOHNSON & JOHNSON FLUFF SPONGEUCleared 510(K)
- K880911BLUNT SPONGEUCleared 510(K)
- K880910ROUND STICK SPONGESUCleared 510(K)
- K880909TRACHEOTOMY SPONGESUCleared 510(K)
- K880907TRIANGLE SPONGEUCleared 510(K)
- K880854STRUNG ABSORBENT BALLSUCleared 510(K)
- K880853CHERRY SPONGEUCleared 510(K)
- K880852ROSEBUD DISSECTORSUCleared 510(K)
- K880851FLAT STICK SPONGEUCleared 510(K)
- K874551ENVINET(TM)UCleared 510(K)
- K872572PHARMANET (TM)UCleared 510(K)
- K874067GUAZE SPONGESUCleared 510(K)
- K874065LAPAROTOMY SPONGESUCleared 510(K)
- K873523PLAIN DRY GAUZEUCleared 510(K)
- K873831EAR AND EYE SPONGESUCleared 510(K)
- K872759AQUATULLE FINE MESH NON-ADHERING DRESSINGUCleared 510(K)
- K872806STICK SPONGE, STRUNG TONSIL SPONGE DOUBLE STRUNGUCleared 510(K)
- K872808CHEVRON TAPE DISSECTOR, 9/16 X 1/4, 9/16 X 1/8UCleared 510(K)
- K871916FRASTEC DRY BURN DRESSINGUCleared 510(K)
- K871917FRASTEC DRY GAUZE BANDAGEUCleared 510(K)
- K871438BANDAGE, MUSLIN, COMPRESSED, CAMOUFLAGED 37X37X52UCleared 510(K)
- K87100518X36,36X36,18X72,24X72 GAUZE COMPRESSUCleared 510(K)
- K8710021X5YD,2X6YD,3X5YD,4X6YD,1/2/3X10YD GAUZEUCleared 510(K)
- K8709932, 3 AND 4 BANDAGE COMPRESSUCleared 510(K)
- K870308WHITE PLUME ABSORBENT GAUZEUCleared 510(K)
- K870314WHITE PLUME GAUZE SPONGEUCleared 510(K)
- K865097AIMED GAUZE SPONGEUCleared 510(K)
- K865095ROLL BANDAGE, GAUZE BANDAGE, VARIOUS SIZESUCleared 510(K)
- K864298ZENEX MEDICAL, INC. GAUZE SPONGESUCleared 510(K)
- K864175SPONGE, SURGICAL, GAUZE, COMPRESSED 2 BY 2 INCHESUCleared 510(K)
- K863932GAUZE, ABSORBENT, STERILE, COMPRESSEDUCleared 510(K)
- K863870GAUZE, NONABSORBABLE, NON-MEDICATED (INTERNAL)UCleared 510(K)
- K8637612X2 SPONGES, NON-STERILE, COTTON FILLEDUCleared 510(K)
- K8637602X2 SPONGES, NON-STERILEUCleared 510(K)
- K863850DRESSING, FIRST AID, FIELD, VARIOUS SIZESUCleared 510(K)
- K863713BANDAGE, GAUZE, TWO-PLY, VARIOUS SIZESUCleared 510(K)
- K863737SPONGES STERILE TWIN PAKT AND SINGLESUCleared 510(K)
- K863714BANDAGE, GAUZE, SIX-PLY, VARIOUS SIZESUCleared 510(K)
- K862126STERILE LAPAROTOMY GAUZE SPONGEUCleared 510(K)
- K861443S1 VAGINAL PACKINGUCleared 510(K)
- K861444S1 NASAL PACKINGUCleared 510(K)
- K861445S1 CAVITY PACKINGUCleared 510(K)
- K861446S1 ORAL PACKINGUCleared 510(K)
- K861308ACCUPAC CUSTOM PACK KERLIX SQUARESUCleared 510(K)
- K861215GAUZE SPONGES USP TYPE VIIUCleared 510(K)
- K861154ALBA HEALTH CARE PLAIN PACKING STRIPUCleared 510(K)
- K854432FALKON STRETCHUCleared 510(K)
- K852412NON-ADHERENT PADUCleared 510(K)
- K8528574 X 4' GAUZE PADUCleared 510(K)
- K852202STRUNG NEURO SPONGE PATTIES, X-RAY OPAGUEUCleared 510(K)
- K852265NON-STERILE GAUZE ROLLER BANDAGESUCleared 510(K)
- K844726GAUZE SPONGE 4X4X12 PLYUCleared 510(K)
- K844702GAUZE ASORBABLEUCleared 510(K)
- K844675APPLIED GAUZE SPONGE 3X3X12UCleared 510(K)
- K844674APPLIED GAUZE SPONGE 2X2X8 PLYUCleared 510(K)
- K844673APPLIED GAUZE SPONGE 4X4X16 PLYUCleared 510(K)
- K844677APPLIED GAUZE SPONGE 2X2X12UCleared 510(K)
- K844676APPLIED GAUZE SPONGE 4X4X8UCleared 510(K)
- K844573ABSORBABLE GAUZE PRODUCTSUCleared 510(K)
- K850093PANAMEDIC GAUZE SPONGESUCleared 510(K)
- K843783WET PACKUCleared 510(K)
- K843782DRY TRAYUCleared 510(K)
- K833867PAREMA K BAND NON-STERILEUCleared 510(K)
- K831917VILENE COTTON GAUZE IIUCleared 510(K)
- K832174GAUZE SPONGE NON-STERILEUCleared 510(K)
- K832173GAUZE SPONGE STERILEUCleared 510(K)
- K832213GAUZE CONVERSION CLASS II STERILEUCleared 510(K)
- K832214GAUZE CONVERSION CLASS I-NON-STERILEUCleared 510(K)
- K831806SUTURE KITS STERILIZED W/GAMA RADIATIONUCleared 510(K)
- K831183GAUZE SPONGE STERILE SPONGEUCleared 510(K)
- K831182GAUZE SPONGE-NON-STERILE SPONGEUCleared 510(K)
- K830261FLORET STRUNG GAUZE SPONGESUCleared 510(K)
- K830268FLORET CYLINDRICAL/BRONCHOSCOPIC/LAMINUCleared 510(K)
- K830267FLORET SPECIAL GAUZE SPONGESUCleared 510(K)
- K830266FLORET KITTNER OR K DISSECTORUCleared 510(K)
- K830264FLORET TONSIL & ADENOID SPONGESUCleared 510(K)
- K830269FLORET NEURO SPONGEUCleared 510(K)
- K830271LAPET & LAPWALL LAPAROTOMY SPONGESUCleared 510(K)
- K830265FLORET DRAIN/TRACHEOTOMY SPONGEUCleared 510(K)
- K830278FLORET GAUZE PACKINGUCleared 510(K)
- K830274FLORET PEANUT SPONGE/STICK & GAUZE PREPUCleared 510(K)
- K823058DOSOMETRIC RELEASE STERILIZATIONUCleared 510(K)
- K823485SURE SNIPUCleared 510(K)
- K821150NU-GAUZE SPONGEUCleared 510(K)
- K821701RAPIDO-LASTIC IN STERILE FORMUCleared 510(K)
- K820195OR SPECIALTIES VAGINAL PACKUCleared 510(K)
- K820106X-RAY GUAZE SPONGESUCleared 510(K)
- K820107GUAZE SPONGES, PLAINUCleared 510(K)
- K813296CONVERTORS STERILE DISP. LAP SPONGE IIUCleared 510(K)
- K812736SOFTCARE BARRIER WET DRESSINGUCleared 510(K)
- K812572GAUZE SPONGESUCleared 510(K)
- K811951DRESSING CHANGE TRAYS & STERILE SPONGESUCleared 510(K)
- K810801DENTMED V-PACKSUCleared 510(K)
- K810200OPTIPORE SCRUB SPONGEUCleared 510(K)
- K803172GAUZE SPONGESUCleared 510(K)
- K802861COMBINATION PADS STERILE SINGLESUCleared 510(K)
- K802863GAUZE SPONGESUCleared 510(K)
- K802862GAUZE PADS STERILE SINGLESUCleared 510(K)
- K802860POST OP. SPONGES STERILEUCleared 510(K)
- K802504SPONGE SURGICAL GUAZE RADIOPAQUEUCleared 510(K)
- K802388MAJOR DRESSING TRAY-MILFORD HOSP.UCleared 510(K)
- K802387MINOR DRESSING TRAY-MILFORD HOSP.UCleared 510(K)
- K802383CUSTOM DRESSING TRAY/CARDINAL CUSHINGUCleared 510(K)
- K802022STERILE GUAZE SWABS CAT.#301-420UCleared 510(K)
- K802010GUAZE SWABS CAT.#251-300 (SIZE & PLY)UCleared 510(K)
- K802005ABSORBENT PAD CAT.#729, 732, 730, 731UCleared 510(K)
- K801999GUAZE BALLS CAT.#601-720UCleared 510(K)
- K800082STORZ SUPER SORB MICRO EYE SPONGEUCleared 510(K)
- K800021NON ADHERANT NEUROLOGICAL SPONGESUCleared 510(K)
- K800020NON ADHERANT WOUND BANDAGESUCleared 510(K)
- K792628STERILIZATION PROCESS/VAGINAL SPONGEUCleared 510(K)
- K792615CELLULOSE TRACHE SPONGEUCleared 510(K)
- K792614TRACHOETOMY SPONGE, NON-ADHERENT CELLUCleared 510(K)
- K792617TRACHEOTOMY SPONGE, NON-ADHERENT BARRIERUCleared 510(K)
- K792618TRACHEOTOMY SPONGE, NON-WOVEN DELNETUCleared 510(K)
- K792616TRACHEOTOMY SPONGE, NON-ADHERENT W/HDPEUCleared 510(K)
- K792612TRACHEOTOMY SPONGE, W/NON-WOVEN NYLONUCleared 510(K)
- K792613TRACHEOTOMY SPONGE, NON-ADHERENTUCleared 510(K)
- K792431VAGINAL PACKINGUCleared 510(K)
- K791872LAP SPONGESUCleared 510(K)
- K791871NEUROLOGICAL SPONGES (PATTIES)UCleared 510(K)
- K791888CATHETER CARE KIT REORDER 7940&7941UCleared 510(K)
- K790631STERAID SURGICAL DRESSINGUCleared 510(K)
- K790467SURGICAL EYE SPONGEUCleared 510(K)
- K781985BURN PAD, DRY, STERILEUCleared 510(K)
- K781420SPECIALTY SPONGESUCleared 510(K)
- K781322STERILE WET DRESSING PACKUCleared 510(K)
- K780818LAPAROTOMY SPONGEUCleared 510(K)
- K780806LAPOROTOMY SPONGEUCleared 510(K)
- K772089LAPAROTOMY SPOGNEUCleared 510(K)
- K771531LAPAROTOMY SPONGESUCleared 510(K)
- K770889BURN DRESSING KITUCleared 510(K)
- K770446SPONGES, LAPAROTOMYUCleared 510(K)
- K761034SURGEX SURGICAL SPONGEUCleared 510(K)
- K761037INTERSORB LAPAROTOMY SPONGEUCleared 510(K)
- K760113SPONGE, LAPAROTOMY GAUZEUCleared 510(K)
- 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
- 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
ISOLYSER
- Page Type
- Cleared 510(K)
- FDA Hosted PDF* The FDA doesn't provide PDFs for all submissions.
- 510(k) Number
- K940765
- 510(k) Type
- Traditional
- Applicant
- THANTEX SPECIALTIES, INC.
- Country
- United States
- FDA Decision
- Substantially Equivalent
- Decision Date
- 12/19/1994
- Days to Decision
- 304 days
- Submission Type
- Statement