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

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RecordFirmDate
DUMEX PAK-ITS COTTON GAUZE PACKING IMPREGNATED WITH HYDROGEL (K980861)Dumex Medical Surgical Products, Ltd.1998-05-20
OLYMPUS SONOSURG SYSTEM (K972114)The Olympus Optical Co.1998-05-18
SURGIDEV SILICONE PUNCTUM PLUG (K980844)Advanced Vision Science1998-05-11
QUIKSTRIP ONE STEP PHENCYCLIDINE (PCP) TEST (K981019)Syntron Bioresearch, Inc.1998-05-07
DUMEX PAK-ITS-ABSORBASALT COTTON GAUZE PACKING (K980777)Dumex Medical Surgical Products, Ltd.1998-05-04
SILICONE PUNCTAL PLUG (K980437)Oasis Medical, Inc.1998-04-30
SIS WOUND DRESSING (K973170)Cook Biotech, Inc.1998-04-30
DUMEX PAK-ITS WOVEN RIBBON PACKING (K980791)Dumex Medical Surgical Products, Ltd.1998-04-29
SORBASTACE (K965034)Hemostace, LLC1998-04-09
ULTRACISION LAPAROSONIC COAGULATING SHEARS (LCS-5(LCSK5 AND LCSB5)) (K980099)Ethicon Endo-Surgery, Inc.1998-04-09
URESIL NEPHRO-URETERAL STENT (K980889)Uresil Corp.1998-04-08
NEVA SYSTEM (K980627)Urometrics, Inc.1998-04-07
SHIELDED CABINET X-RAY RADIATION SOURCE DEVICE MODEL RS 3000 (K974210)Rad-Source, Inc.1998-03-30
TUMORLOCALIZER MRI (K962615)Ferguson Medical1998-03-19
20 ML NORMAL SALINE TOPICAL SOLUTION, 0.9% W/V SODIUM CHLORIDE (K972185)Steripak, Ltd.1998-03-05
FLEXIGEL-G HYDROGEL WOUND DRESSING (K980097)Innovative Technologies , Ltd.1998-03-04
SIMPLICARE THIN FILM WOUND DRESSINGS (K980209)Hollister, Inc.1998-02-20
JTECH ADJUSTER REFLEX GUN (K974376)J-Tech Medical, Inc.1998-02-18
ALGOPLAQUE FILM EXTRA THIN HYDROCOLLOID DRESSING (K974348)Laboratoires Urgo S.A.1998-02-13
HYDROFERA FEMORAL WICK (K974316)Hydrofera, LLC1998-02-13
BALDUR NON-STERILE COTTON SPONGES (K974347)Baldur Systems Corp.1998-02-10
SPYROFLEX FOAM ISLAND WOUND DRESSING, SPYROFLEX FOAM ISLAND WOUND DRESSING, TINTED, SPYROFOAM (K974520)Innovative Technologies (Us), Inc.1998-02-06
SILICONE TISSUE/INFLATABLE TISSUE EXPANDER (K974209)Specialty Surgical Products, Inc.1998-02-06
HEMORRELIEF DEVICE (K973590)A.Stein - Regulatory Affairs Consulting1998-02-05
QUICKSCREEN ONE STEP PCP SCREENING TEST (K974582)Phamatech1998-02-04
ACTIVATOR II (K973506)Activator Methods, Inc.1998-01-27
ATRION MEDICAL PRODUCTS LACRIMAL INTUBATION SET (K973633)Atrion Medical Products, Inc.1998-01-16
ATRION MEDICAL COATED LACRIMAL INTUBATION SET (K973872)Atrion Medical Products, Inc.1998-01-08
KENDALL CURITY IODOFORM PACKING STRIP (K973763)Kendall Healthcare Products Co. Div.Of Tyco Health1997-12-31
DUODERM HYDROACTIVE GEL (K973806)Convatec, A Bristol-Myers Squibb Co.1997-12-29
DUODERM CONTROL GEL FORMULA BORDER DRESSING (K973688)Convatec, Ltd.1997-12-23
DUODERM HYDROACTIVE PASTE (K973807)Convatec, A Bristol-Myers Squibb Co.1997-12-23
DUODERM HYDROACTIVE DRESSING (K973689)Convatec, Ltd.1997-12-23
DUODERM CGF CONTROL GEL FORMULA DRESSING (K973632)Convatec, A Division of E.R. Squibb & Sons1997-12-22
AQUA PATCH (K973693)Pci Technology1997-12-18
COMBIDERM ACD (K973717)Convatec, A Bristol-Myers Squibb Co.1997-12-17
DUODERM EXTRA THIN CGF DRESSING (K973716)Convatec, A Bristol-Myers Squibb Co.1997-12-17
KENDALL CURITY PETROLATUM GAUZE (K973511)Kendall Healthcare Products Co. Div.Of Tyco Health1997-12-16
N-TERFACE (K973538)Winfield Laboratories, Inc.1997-12-16
KENDALL XEROFORM PETROLATUM DRESSING (6311,6312,6313,6314,6315,6316,6317) (K973507)Kendall Healthcare Products Co. Div.Of Tyco Health1997-12-15
INVOTEC CLEAN PAD (K973580)Invotec International, Inc.1997-12-10
B.U.S. ENDOTRON (K972148)Medicamat S.A.1997-12-10
UAS ULTRASONIC ASPIRATOR SYSTEM (K971580)Wells Johnson Co.1997-12-09
IT HYDROCOLLOID WITH ZINC (K973855)Innovative Technologies , Ltd.1997-12-01
ARGLAES-AB ANTIMICROBIAL BARRIER ISLAND DRESSING (K973657)Maersk Medical, Ltd.1997-12-01
PIN CARE KIT (K973299)Brown Medical Industries1997-11-26
3M TEGADERM TRANSPARENT DRESSING, 3M TEGADERM TRANSPARENT DRESSING (FIRST AID DELIVERY), 3M TEGADERM HP TRANSPARENT DRES (K973036)3M Healthcare1997-11-12
VISTA EYESHOWER (K971134)John Branch1997-11-04
SUPER SILIPLUGS EAR PLUGS (K972923)Interview Medical Technology Corp.1997-10-27
SPYROFLEX PIGMENTED WOUND DRESSING/SPYROFLEX WOUND DRESSING TINTED (K964398)Polymedica Industries, Inc.1997-10-24
AUTO SUTURE BONE WAX (K971680)United States Surgical, A Division of Tyco Healthc1997-10-24
TRANSPARENT FILM DRESSING, INTELLIGENT FILM DRESSING (K973312)Innovative Technologies , Ltd.1997-10-22
HYDRASORB STERILE DRESSING (K973260)Avitar, Inc.1997-10-21
DISSECTRON PORTABLE UNIT (K972612)Satelec1997-10-08
MODIFIED CEDIA DAU PCP ASSAY (K972963)Boehringer Mannheim Corp.1997-09-22
LYOCELL WOUND DRESSING/SURGICAL SPONGE (K972458)Courtaulds Fibers, Inc.1997-09-19
SEAGER ELECTROEJACULATOR (K962379)National Rehab Hospital1997-09-18
OPPORTUNITY I.V. START KIT (K971093)Opportunity, Inc.1997-09-16
OPPORTUNITY SUTURE REMOVAL KIT (K971095)Opportunity, Inc.1997-09-16
OPPORTUNITY INCISION AND DRAINAGE TRAY (K971088)Opportunity, Inc.1997-09-16
ROOT APEX LOCATOR (K972407)Toei Electric Co., Ltd.1997-09-11
PUNCTUAL OCCLUDER (K972523)Odyssey Medical, Inc.1997-09-09
SCULPTURE (K971609)Servizi Medico Estetici Italinai Srl.1997-08-14
AMERIGEL OINTMENT SATURATED WOUND DRESSING (K971918)Amerx Health Care Corp.1997-08-12
ARGLAES FILM DRESSING (K970566)Maersk Medical, Ltd.1997-07-29
VIBRA-SURGE SYSTEM MODEL VS2120 (K971533)Sonics & Materials, Inc.1997-07-25
MENTOR ULTRASOUND ASSISTED TISSUE REMOVAL SYSTEM (TRS) (K970471)Mentor Corp.1997-07-17
ULTRACISION 5MM LAPAROSONIC HOOK BLADES, ULTRACISION HS2 BLADE (K971302)Ethicon Endo-Surgery, Inc.1997-07-07
NASAL SEPTAL BUTTON (K972060)Boston Medical Products, Inc.1997-07-03
ULTRASONIC HAND INSTRUMENTS (K971861)United States Surgical, A Division of Tyco Healthc1997-07-01
RAND SURGICAL SPONGE (K971178)Trans Aire1997-06-27
HYDROCOLLOID WOUND DRESSINGS (K971126)Innovative Technologies , Ltd.1997-06-24
PRIMED PRIME-PLUS COTTON GAUZE SPONGES (K971075)Primeline Medical Products, Inc.1997-06-22
LAMIN-2 HYDRATING GEL (K970153)Procyte Corp.1997-06-05
SILICONE PUTTY EAR PLUGS (K971517)Bentec Medical, Inc.1997-06-02
OSMOCYTE WOUND MANAGER SHEET DRESSING (K965143)Procyte Corp.1997-05-22
DUKAL ABD COMBINE PAD (K970457)Dukal Corp.1997-05-08
DUKAL NON ADHERENT DRESSING (K970455)Dukal Corp.1997-05-08
KENDALL HYDROPHILIC POWDER WOUND DRESSING (K970266)Kendall Healthcare Products Co. Div.Of Tyco Health1997-04-23
PUNCTUAL OCCLUDER (K970631)Odyssey Medical, Inc.1997-04-23
RONIX II ROTARY ULTRASONIC SURGICAL SYSTEM (K964742)Aziz Y. Anis, M.D.1997-04-22
HERRICK ULTIMATE PUNCTUM PLUG (K963708)Lacrimedics, Inc.1997-04-14
AMERIGEL OINTMENT (K970133)Amerx Health Care Corp.1997-04-14
HERRICK ULTIMATE PUNCTUM PLUG (K963501)Lacrimedics, Inc.1997-04-14
B. BRAUN MEDICAL INC. TRANSORBENT AND THINSITE BORDER DRESSING (K970453)B.Braun Medical, Inc.1997-04-11
ACRYDERM GEL WOUND DRESSING (K970693)Acrymed, Inc.1997-03-21
ALGOPLAQUE HYDROCOLLOID DRESSING (K970518)Laboratoires Urgo S.A.1997-03-21
SIMAR, INC. SURGICAL DRESSING (K970020)Simar, Inc.1997-03-20
RADIACARE ORAL WOUND RINSE (K964852)Carrington Laboratories, Inc.1997-03-03
TOWNLEY FACET/PEDICULAR SCREW PLATING SYSTEM (K953076)Sofamor Danek USA,Inc.1997-02-28
IAMIN IMPREGNATED GAUZE DRESSING (K965005)Procyte Corp.1997-02-24
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
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