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3,051 FDA 510(k) clearances · Device class

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RecordFirmDate
SPYROGEL HYDROGEL WOUND AND BURN DRESSING SA (K991287)Advanced Medical Solutions Group Plc1999-06-29
SYMTEX GAUZE PADS (1'S) AND SYMTEX GAUZE SPONGES STERILE 2'S AND STERILE 10'S (K991215)Symtex Healthcare Corp.1999-06-11
AT HOME DRUG TEST, MODEL 9171 (K991824)Phamatech1999-06-11
VITOP DRESSING (K990974)Wonder & Bioenergy Hi-Tech America, Inc.1999-06-09
MODIFICATION TO WOUN'DRES (K991202)Coloplast Corp.1999-06-04
AT HOME COCAINE & THC SCREENING TEST, MODEL 9170 (K991641)Phamatech1999-06-01
DERMAPHYLYX FILM WOUND DRESSING AND HEALIAN FILM WOUND DRESSING (K990875)Dermaphylyx, Inc.1999-05-27
DERMAPHYLYX HYDROCOLLOID WOUND DRESSING, HEALIAN HYDROCOLLOID WOUND DRESSING (K990891)Dermaphylyx, Inc.1999-05-27
SONOTOME (K990572)Sonokinetics, Inc.1999-05-21
LACRIMAL INTUBATION SET, DACRYOCYSTORHINOSTOMY (DCR) SET (K990672)Hurricane Medical1999-05-18
SIGNADRESS DUODERM DRESSING (K990964)Convatec, A Division of E.R. Squibb & Sons1999-05-18
GAUZE SPONGES: LAPAROTOMY SPONGE, X-RAY DETECTABLE (K990584)Broadline Medical Industries1999-04-23
FLEXPLUG (K991130)Eagle Vision, Inc.1999-04-20
DUMEX IODOFORM PACKING STRIP (K990332)Dumex Medical Surgical Products, Ltd.1999-04-14
HELIDERM COLLAGEN WOUND DRESSINGS 0.5 GRAM AND 1.0 GRAM (K990086)Integra Lifesciences Corp.1999-03-31
DUODERM HYDROACTIVE GEL WOUND DRESSING (K990368)Convatec, A Bristol-Myers Squibb Co.1999-03-26
DERMAFLEX WOUND DRESSING, DERMAFLEX FOAM WOUND DRESSING, HEALIAFLEX WOUND DRESSING, HEALIAFOAM WOUND DRESSING (K990438)Dermaphylyx, Inc.1999-03-25
SILON DUAL-DRESS (K990042)Bio Med Sciences, Inc.1999-03-19
HUTCHISON INFLATABLE SILICONE TISSUE EXPANDERS (K983385)Hutchison Intl., Inc.1999-03-15
ULTRACISION HARMONIC SCALPEL HAND PIECE (K990430)Ethicon Endo-Surgery, Inc.1999-03-12
HA ABSORBENT WOUND DRESSING (K984388)Convatec, A Division of E.R. Squibb & Sons1999-03-03
MEPITEL NON ADHERENT SILICONE DRESSING (K984371)Molnlycke Health Care, Inc.1999-03-03
MODIFICATION OF CUTINOVA CAVITY DRESSING (K984597)Beiersdorf-Jobt, Inc.1999-03-01
HYPERGEL 20% HYPERTONIC SALINE GEL (K984370)Molnlycke Health Care, Inc.1999-03-01
MODIFICATION OF CUTINOVA HYDRO DRESSING (K984595)Beiersdorf-Jobt, Inc.1999-03-01
MODIFICATION OF CUTINOVA FOAM DRESSING (K984599)Beiersdorf-Jobt, Inc.1999-03-01
VISUALINE II (ALSO KNOWN AS SUNLINE) PHENCYCLIDINE (K983790)Sun Biomedical Laboratories, Inc.1999-03-01
MODIFICATION OF CUTINOVA THIN DRESSING (K984593)Beiersdorf-Jobt, Inc.1999-03-01
NORMLGEL 0.9% ISOTONIC SALINE GEL (K984368)Molnlycke Health Care, Inc.1999-02-22
SILVERLON ISLAND DRESSING, SILVERLON ISLAND PAD (K984208)Argentum International, LLC1999-02-22
CROSSTEX NON-WOVEN SPONGES (K984187)Crosstex Intl.1999-02-18
MAMMARY SIZER, MAMMARY PROTHESIS SIZER (K984106)Specialty Surgical Products, Inc.1999-02-12
GAUZE, SPONGES, CAT # 11-003 (K983016)Vitalcare Group, Inc.1999-02-12
MODIFICATION OF BIONECT HYDROGEL FOAM (K984267)Fidia Pharmaceutical Corp.1999-02-10
BIONECT HYDROGEL (K984413)Fidia Pharmaceutical Corp.1999-02-10
MODIFICATION OF BIONECT HYDROGEL GAUZE PADS (K984262)Fidia Pharmaceutical Corp.1999-02-10
MODIFICATION OF BIONECT HYDROGEL SPRAY (K984266)Fidia Pharmaceutical Corp.1999-02-10
MODIFICATION OF BIONECT CLEAR HYDROGEL (K984264)Fidia Pharmaceutical Corp.1999-02-10
COMPEED PSORIASIS DRESSING (K982493)Coloplast Corp.1999-01-28
BURN-AID HYDROGEL, BURN-AID BURN DRESSING, BURN-AID BURN BLANKET (K984082)Emox 911 CC1999-01-28
ONE STEP URINE DRUG OF ABUSE: PHENCYCLIDINE (PCP) TEST (K981363)Tcpi, Inc.1998-12-22
BIATAIN FOAM DRESSING (K983163)Coloplast Corp.1998-12-16
NU-GEL * WOUND DRESSING (K983362)Johnson & Johnson Medical, Inc.1998-12-16
BIATAIN FOAM ADHESIVE DRESSING (K983173)Coloplast Corp.1998-12-16
SPYROGEL HYDROGEL WOUND AND BURN DRESSING (K982804)Innovative Technologies (Us), Inc.1998-12-16
FIBRA SONICS ULTRASONIC SURGICAL ASPIRATOR SYSTEM, MODEL 1000 CONSOLE MODEL (K983199)Fibra Sonics, Inc.1998-12-14
DYNAREX TRACHEOSTOMY SPONGE (K983348)Dynarex Corp.1998-12-11
SEARE BIOMEDICAL SILICONE TISSUE EXPANDER (K983792)Seare Biomedical Corp.1998-12-11
ALOE THERAPY ORAL RINSE (K983182)Carrington Laboratories, Inc.1998-12-10
INNOVATIVE TECHNOLOGIES HYDROCOLLOID AND INTELLIGENT HYDROCOLLOID WOUND DRESSINGS (K983303)Innovative Technologies , Ltd.1998-12-09
MENTOR ULTRASOUND-ASSISTED TISSUE REMOVAL SYSTEM (K983065)Mentor Corp.1998-12-01
SURESKIN PLUS STANDARD, SURESKIN PLUS BORDER, SURESKIN PLUS THIN (K983249)Euromed, Inc.1998-11-25
TIELLE PLUS HYDROPOLYMER ADHESIVE DRESSING (K983234)Johnson & Johnson Medical, Div. of Ethicon, Inc.1998-11-25
SWEEN WOUN'DRES (K983042)Coloplast Corp.1998-11-25
MICROMEDICS NASAL SEPTAL BUTTON (K982667)Micromedics, Inc.1998-11-24
STARRYSHINE GAUZE SPONGE (K983450)T.C. Dental Products, Inc.1998-11-12
BRENNEN MEDICAL BETA GLUCAN GEL (K982825)Brennen Medical, Inc.1998-11-06
ALLEGRO ULTRASONIC SOFT TISSUE ASPIRATOR (K980895)California Institute of Tissue Eng. & Instrumenti1998-11-06
AUTO-LYTE PCP EIA, MODEL #1254U (K982801)OraSure Technologies, Inc.1998-11-04
MODIFICATION TO TIELLE HYDROPOLMER DRESSING (K983394)Johnson & Johnson Medical, Div. of Ethicon, Inc.1998-11-03
MEPILEX (K983184)Molnlycke Health Care, Inc.1998-10-28
ULTRACISION 5MM INSTRUMENTS (K983316)Ethicon Endo-Surgery, Inc.1998-10-21
ACUTEK'S HYDROCOLLOID WOUND DRESSING, TIB 197013 (K974891)Acutek Adhesive Specialties, Inc.1998-10-21
NEUFINISH RESURFACING CREAM (K982577)Neutrogena Corp.1998-10-21
QUICKSCREEN AT HOME DRUG TEST, MODEL 9149/9150 (K982621)Phamatech1998-10-16
ACUTEK'S HYDROCOLLOID WOUND DRESSING, TIB 997002 (K974890)Acutek Adhesive Specialties, Inc.1998-10-13
BTF THIN FILM WOUND DRESSING (K982939)Bioderm, Inc.1998-10-13
ACUTEK'S HYDROCOLLOID WOUND DRESSING, TIB 197012 (K974892)Acutek Adhesive Specialties, Inc.1998-10-13
ACCU-BITE HOME KIT DISCLUDER (K980953)Jerome M. Simon1998-10-07
VMT SYSTEM (K971549)Target Health, Inc.1998-10-05
JOAN II (K982648)Celanese Acetate Co.1998-09-30
SILVERLON CONTACT WOUND DRESSING (K981299)Argentum International, LLC1998-09-25
POLYTUBE (K982306)Ferris Mfg. Corp.1998-09-22
BIONECT HYDROGEL SPRAY (K973724)Fidia Pharmaceutical Corp.1998-09-22
BIONECT HYDROGEL FOAM (K973722)Fidia Pharmaceutical Corp.1998-09-22
FIBRA SONICS ULTRASONIC SURGICAL ASPIRATOR SYSTEM, MODEL 2100 USSTA (K980930)Fibra Sonics, Inc.1998-09-22
BIONECT CLEAR HYDROGEL (K973725)Fidia Pharmaceutical Corp.1998-09-22
BIONECT HYDROGEL GAUZE PADS (K973721)Fidia Pharmaceutical Corp.1998-09-22
VISIVOX, MODEL V-2 (K982396)Rsq, LLC1998-09-14
URESIL PERCUTANEOUS DRAINAGE CATHETERS WITH HYDROPHILIC COATING (K981344)Uresil Corp.1998-09-10
MAMMARY SIZER (K982258)Specialty Surgical Products, Inc.1998-09-08
MODIFICATION TO ALLIGER ULTRASONIC SURGICAL SYSTEM, MODEL AUSS-4 (K982841)Misonix, Inc.1998-09-04
3M TEGAGEN HI ALGINATE DRESSING & 3 M TEGAGEN HG ALGINATE DRESSING, MODEL #'S 90110,90112,90114,90120, 90210,90212,90214 (K982638)Innovative Technologies , Ltd.1998-08-21
FIBRCOL PLUS COLLAGEN WOUND DRESSING WITH ALGINATE (K982597)Johnson & Johnson Medical, Inc.1998-08-20
SILIMED TISSUE EXPANDER (K981852)Silimed, LLC1998-08-05
CICANET WOUND CONTACT LAYER DRESSING - 2 X 3 IN. MODEL 59100600, CICANET WOUND CONTACT LAYER DRESSING - 4 X 5 IN. MODEL0 (K981713)Smith & Nephew, Inc.1998-07-31
ULTRAPAK E (K981596)Ultradent Products, Inc.1998-07-31
BRENNEN MEDICAL BETA GLUCAN CREAM, MACROPRO (K980962)Brennen Medical, Inc.1998-07-29
NTI CLENCHING SUPPRESSION SYSTEM (K981546)Heraeus Kulzer, Inc.1998-07-15
MAGNETIC PORT SILICONE TISSUE EXPANDER (K982067)Specialty Surgical Products, Inc.1998-07-13
ANU ICE (K981428)Cryoptherapy Pain Relief Products, Inc.1998-07-07
CUSA EXCEL ULTRASONIC SURGICAL ASPIRATOR SYSTEM (K981262)Valleylab, Inc.1998-07-06
SENSE TECHNOLOGY INC. FRAS, SENSE TECHNOLOGY INC. PULSTAR (K973914)Sense Technology, Inc.1998-06-30
INNOVATIVE TECHNOLOGIES TRANSPARENT FILM AND INTELLIGENT FILM WOUND DRESSING (K981753)Innovative Technologies , Ltd.1998-06-30
PHYTACARE ALGINATE HYDROGEL WOUND DRESSING (K980132)Phytatek Laboratories, Inc.1998-06-26
SOLOSITE GEL CONFORMABLE DRESSING (K981150)Smith & Nephew, Inc.1998-06-22
X-CELL WOUND DRESSING (K974251)Xylos Corporation1998-06-22
MANAN GENERAL UTILITY DRAINAGE CATHETER (K980193)Medical Device Technologies, Inc.1998-05-27
MANAN NEPHROSTOMY DRAINAGE CATHETER (K980192)Medical Device Technologies, Inc.1998-05-27
QUIKPAC II ONE STEP PHENCYCLIDINE (PCP) TEST (K981292)Syntron Bioresearch, Inc.1998-05-26
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