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3,119 FDA 510(k) clearances · Medical specialty

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RecordFirmDate
BIPOLAR SHOULDER PROSTHESIS-SHELL(RD-113130/33, BIANGULAR MODULAR HEAD(RD-113101/41/42,BIOMODULAR MODULAR HEAD(RD-113143 (K960363)Biomet, Inc.1997-02-18
BIONECT CREAM (K963004)Fidia Pharmaceutical Corp.1997-02-12
MITRAFLEX PIGMENTED WOUND DRESSING (K964701)Polymedica Industries, Inc.1997-02-07
IAMIN WET DRESSING (COPPER-SALINE) (K964468)Procyte Corp.1997-02-03
BIAFINE WOUND DRESSING EMULSION (K964240)Medix Pharmaceuticals Americas, Inc.1997-01-22
CUSA SYSTEM 200C ULTRASONIC ASPIRATOR/CUSA SYSTEM 200T ULTRASONIC ASPIRATOR/CUSA LAP ACCESSORY (K964601)Valleylab, Inc.1997-01-16
SMART ADJUSTER (SA201) (K962239)Sigma1997-01-10
PANOGAUZE NON-WOVEN HYDROGEL DRESSING (K964620)Sage Pharmaceuticals, Inc.1997-01-09
PUNCTUM PLUGS & READY-SET PUNCTAL PLUGS (K964774)Fci Ophthalmics, Inc.1996-12-20
REPLIDERM WOUND DRESSING (K963228)Orphan Medical, Inc.1996-12-18
MULTIDEX HYDROPHILIC WOUND DRESSING GEL (K962917)Lange Medical Products, Inc.1996-12-16
ONTRAK TESTCUP 5 (MODIFICATION) (K964355)Roche Diagnostic Systems, Inc.1996-12-13
BRENNEN MEDICAL GLUCAN II WOUND DRESSING (K964241)Brennen Medical, Inc.1996-12-12
VERDICT PCP (K963692)Editek, Inc.1996-12-10
NASP TRANSPARENT DRESSING (K963753)North American Sterilization & Packaging Co.1996-11-29
GAUZE SPONGE, NON X-RAY DETECTABLE (K963724)Grand Medical Products1996-11-29
OLYMPUS ULTRASONIC SURGICAL SYSTEM (USU) (K962952)Olympus Optical, Co.1996-11-29
TRACHEOSTOMY KIT (K963720)Grand Medical Products1996-11-27
GAUZE COMPRESS (K960615)Certified Safety Mfg., Inc.1996-11-25
GAMMACELL 3000 ELAN, VERSION 1.0 AND GAMMACELL 1000 ELITE, VERSION 1.0 (K963497)Nordion International, Inc.1996-11-08
DERMAMEND GEL (K962089)Dermarx Corp.1996-11-05
ULTRACISION 5MM HARD SHEATH LAPAROSONIC BLADE (K962584)Ethicon Endo-Surgery, Inc.1996-11-04
EZ-SCREEN PROFILE (K963233)Editek, Inc.1996-10-31
DRAIN/SLIT SPONGE (NON-STERILE AND STERILE) (K963188)Codi International BV1996-10-30
HEARSAVER (K962292)Emtech Laboratories1996-10-29
SPYROFLEX PIGMENTED WOUND DRESSING (K963623)Polymedica Industries, Inc.1996-10-25
CHONDROPROTEC (K961930)The Hymed Group Corp.1996-10-15
SURGICADE GAUZE SPONGE (K962972)Accunex Canada,Inc.1996-10-11
APEX FINDER MODELS 7005 (K962803)Sybron Dental Specialties, Inc.1996-10-08
MENTOR INJECTION PORT DETECTOR (IPD) (K963066)Mentor Corp.1996-09-27
SURESKIN STANDARD, BORDER, AND THIN (K963039)Euromed A/S1996-09-23
MAMMARY SIZER (K961356)General Surgical Innovations1996-09-23
SIGNALDRESS (K962590)Convatec, A Division of E.R. Squibb & Sons1996-09-20
ULTRA-SAFE ULTRASONIC ASPIRATOR SYSTEM (K962525)Morwel Corp.1996-09-19
RYDER LACRIMAL INTUBATIONSET (K962151)Ryder Intl. Corp.1996-09-18
DERMAPLEX HYDROGEL WOUND DRESSING (K962513)Maxxim Medical1996-09-12
NEOSONO (K962853)L.S. Scientific1996-09-12
CARRASYN HYDROGEL WOUND DRESSING,CARRAGAUZE PADS,CARRAGAUZE STRIPS,CARRASORB M FDG (K962218)Carrington Laboratories, Inc.1996-09-12
DRAIN/SLIT SPONGE (NON-STERILE AND STERILE) (K963134)Igenics, Inc.1996-09-06
ACRYNOODLES ABSORBENT WOUND DRESSING (K962851)Acrymed, Inc.1996-09-06
DERMAPLEX HYDROGEL WOUND DRESSING (2X2,4X4,4X8,6X10) (K962439)Richard Hamer Assoc., Inc.1996-09-03
PRO-FECT STERILE GAUZE SPONGES (K962227)Network Trading Corp. Dba Grand Intl.1996-08-19
STOP-N-GROW (K960843)European Touch Co., Inc.1996-08-12
HYCOAT (K960686)The Hymed Group Corp.1996-08-12
PULPDENT SODIUM HYPOCHLORITE SOLUTION (K962743)Pulpdent Corp.1996-08-06
P1R PLASMA TREATMENT SET FOR USE IN PLASMAPHERESIS WITH THE FRESENIUS AS104 CELL SEPARATOR (K961706)Fresenius USA, Inc.1996-07-31
PROTEC STERILE GAUZE SPONGE (K961773)Derivadas Degasa S.A. DE C.V.1996-07-29
READY-SET PUNCTAL PLUGS (K961909)Fci Ophthalmics, Inc.1996-07-25
CIRCLE NEPHROSTOMY CATHETER SET (K961933)Cook Urological, Inc.1996-07-18
PROFORE FOUR-LAYER BANDAGE SYSTEM KIT (K961775)Smith & Nephew United, Inc.1996-07-16
WOUND HYDROGEL & STERILE WOUND HYDROGEL (K961766)Renaissance Pharmaceutical, Inc.1996-07-15
WOUND HYDROGEL AND/OR STERILE WOUND HYDROGEL (K961316)Renaissance Pharmaceutical, Inc.1996-07-15
CARASYN HYDROGEL WOUND PRODUCTS (K961758)Carrington Laboratories, Inc.1996-07-11
NEOSONO 2000 (K955088)American Medical & Dental Corp.1996-07-10
EPIVIEW (K961319)Convatec, A Division of E.R. Squibb & Sons1996-07-08
MEDCARE TRACHEOSTOMY CARE TRAY (K961167)Medcare Medical Group, Inc.1996-07-02
STERILE GAUZE SPONGE - PICK-UPS 12PLY (GS-412), PICK-UPS 16PLY (GS-416) (K962234)Howard Medical Co.1996-06-28
ULTRACUT 2000 (K960374)Ultralase Technologies, Inc.1996-06-28
MPM HYDROGEL DRESSING (NON-STERILE) (K962160)Mpm Medical., Inc.1996-06-26
CODI SYNTHETIC SPONGE(NON-STERILE AND STERILE) (K961061)Codi International BV1996-06-06
HAEMONETICS THERAPEUTIC PLASMA EXCHANGE SET (K953681)Haemonetics Corp.1996-06-04
ACCUSIGN, BIOSIGN PCP (K961266)Princeton BioMeditech Corp.1996-05-31
EMERALD STERILE GAUZE SPONGE (K961581)Emerald Medical, Inc.1996-05-28
DEROYAL WOUND CARE MULTIDEX PLUS GEL WOUND DRESSING (K961085)Debusk Knitting Mills, Div. Deroyal Industries1996-05-21
THE CHEN MEDIUM (K954548)Chen Ophthalmic Laboratories1996-05-20
BURN-AID HYDROGEL,BURN DRESSING,BURN BLANKET (K961067)Medtrak Intl., Inc.1996-05-16
PMMA CLASIC (K955777)Rand Scientific Corp.1996-05-16
BIO-DRESSING, STERILE ISLAND DRESSING (K961098)K. W. Griffen Co.1996-05-03
INTEGRATOR (K950646)Moyco Union Broach, Div., Moyco Technologies, Inc.1996-04-30
SHARPLAN ULTRA LAPAROSCOPIC HANDPIECE (K960040)Sharplan Lasers, Inc.1996-04-29
GASTROTEC (K954401)Patrick C. Jacobssen1996-04-25
NHMC DRESSING TRAY (K960523)National Healthcare Mfg. Corp.1996-04-04
DERMASEAL (K960847)Bellingham Medical, Inc.1996-04-04
THE VIRTUAL M-332 (K960500)Virtual Corp.1996-04-03
DYNAREX NON-WOVEN SPONGE (K960388)Dynarex Corp.1996-04-01
MANAN GENERAL UTILITY DRAINAGE CATHETER (K953713)Manan Medical Products, Inc.1996-03-26
MANAN UNIVERSAL SUMP DRAINAGE CATHETER (K953601)Manan Medical Products, Inc.1996-03-26
PROTEC ROLL GAUZE (K960093)Derivadas Degasa S.A. DE C.V.1996-03-25
CARRASYN HYDROGEL WOUND DRESSING/FDG PADS/CARAGAUZE STRIPS/PADS (MODIFICATION) (K960428)Carrington Laboratories, Inc.1996-03-21
NIGHTGUARD DIAGNOSTIC APPLIANCE (K955701)Cycura Corp.1996-03-08
RITLENG BICAN.LACR.SETS/SELF THREAD. MONOKAS(CHG.IN STER.) (K955671)G.W.B. Intl., Ltd.1996-03-06
HAND HELD ATLAS INSTRUMENT (K955540)Spinalight, Inc.1996-03-04
SURESKIN BORDER (K960393)Euromed A/S1996-03-01
SURESKIN THIN (K960404)Euromed A/S1996-03-01
SURESKIN STANDARD (K960394)Euromed A/S1996-03-01
BURNAID BURN FIRST AID DRESSING (K953505)Rye Pharmaceuticals Pty. , Ltd.1996-02-09
QUEGEL HYDROPHILIC WOUND DRESSING (K955400)Questor Pharma, Inc.1996-02-09
GENERAL USE SYNTHETIC SPONGE (STERILE) (K955527)Igenics, Inc.1996-02-05
IAMIN GEL WOUND DRESSING (K953853)Procyte Corp.1996-02-05
SYNTHETIC SPONGE (K955165)Igenics, Inc.1996-02-05
DUKAL TRANSPARENT WOUND DRESSING (K955476)Dukal Corp.1996-01-18
TECNOL HYDROGEL WOUND DRESSING (K955575)Tecnol Medical Products, Inc.1996-01-17
HYCURE (K955506)The Hymed Group Corp.1996-01-17
PROTEC GAUZE SPONGE (K955321)Derivados DE Gasa, S.A. DE C.V.1995-12-19
SPYROCOLLOID WOUND DRESSING (K955383)Polymedica Industries, Inc.1995-12-13
AQUAFLO BTP HYDROGEL WOUND DRESSING (K952938)Sherwood Medical Co.1995-12-08
ROOT CANAL LENGTH MEASURING DEVICE (K953867)J. Morita USA, Inc.1995-12-01
TECNOL SALINE WET DRESSING (K954243)Tecnol Medical Products, Inc.1995-11-29
SPYROFLEX SKIN PROTECTOR (K953885)Polymedica Industries, Inc.1995-11-29
ATLAS ORTHOGONAL PERCUSSION INSTTUMENT (K951217)Sweat Chiropractic Clinic1995-11-21
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