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

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RecordFirmDate
HOOD NASAL SEPTAL BUTTON (K920994)Hood Laboratories1992-05-15
MICRO-COLL COLLAGEN DERMAL WOUND SPRAY (K920642)Micro-Collagen Pharmaceutics, Ltd.1992-04-29
BIOLEX WOUND GEL, (K920050)Catalina Biomedical Corp.1992-04-07
SHARPLAN MODEL ULTRA ULTRASONIC SURG ASPIRATOR (K913848)Sharplan Lasers, Inc.1992-03-27
ABUSCREEN ONLINE FOR PHENCYCLIDINE (K920935)Roche Diagnostic Systems, Inc.1992-03-18
AMS SPHINCTER 800 URINARY PROSTHESIS (K912934)American Medical Systems, Inc.1992-03-18
PHENCYCLIDINE EIA ASSAY, MODIFICATION (K920957)Diagnostic Reagents, Inc.1992-03-18
URITEC TEST STRIP & HUMAN URINE + & - TEST CONTROL (K912888)Dynagen, Inc.1992-02-24
VISITEC CANALICULAR STENT (K915809)Visitec Co.1992-02-24
SILVER FOAM WOUND DRESSING (K914579)Vitaphore Corp.1992-02-21
DERMAPROOF (K914840)Pharmalett Medical Care, Holland B.V.1992-01-31
CARRINGTON WOUND DRESSING 4X4(TM) (K915001)Carrington Laboratories, Inc.1992-01-31
STERILE GAUZE PK STRIPS SAT W/CARR GEL WOUND DRESS (K915002)Carrington Laboratories, Inc.1992-01-31
CURITY VENTED DRESSING SYSTEM (K915635)Kendall Healthcare Products Co. Div.Of Tyco Health1992-01-31
EMIT D.A.U. PHENCYCLIDINE ASSAY (K915728)Syva Co.1992-01-27
PTI INTRA-ART (TM) PICK-UP WICKS (K905068)Pioneering Technologies, Inc.1991-12-31
PHENCYCLIDINE EIA ASSAY (K915179)Diagnostic Reagents, Inc.1991-12-09
VIADERM (K914024)Abs Life Sciences1991-12-04
KINESTHETIC ABILITY TRAINER (K.A.T., MODEL 1000) (K911795)Breg, Inc.1991-11-19
IL TEST(TM) PHENCYCLIDINE (K913743)Instrumentation Laboratory CO1991-11-07
THERMA-H (K905276)Kure Swiss Medical AG Corp.1991-11-07
BONE-TEMNO/STERNUM-TEMNO (K913306)Proact, Ltd.1991-11-01
MULTI-VIEW BIFOCALS (K913081)Camp Contact Lenses1991-10-23
PCP DIRECT RIA KIT (I-125) (K913864)Immunalysis Corporation1991-10-11
I.V. STARR KIT (K912161)Medical Device Inspection Co., Inc.1991-10-08
STERI-SWAB (K912731)Westlock Investments (Usa), Inc.1991-10-02
SKINTEMP (K913023)Biocore1991-10-02
INCARE HOT/ICE ABSORBENT INTERFACE (K913035)Hollister, Inc.1991-09-25
EYE PAD (K912955)Cal West Trading Co.1991-09-10
GAUZE PACKING, SURGICAL STERILE AND NON-STERILE (K913575)Keilei Intl., Inc.1991-09-06
2ND SKIN MOIST BURN PADS WITH ALOE (K911550)Spenco Medical Corp.1991-09-06
DUODERM HYDROACTIVE DRESSING AND CGF DRESSINGS (K912667)Convatec, A Division of E.R. Squibb & Sons1991-09-04
ALGINATE FIBER (K905040)Shepherd Medical Corp.1991-08-21
SILON(TM) TRANSPARENT WOUND DRESSING (K912032)Bio Med Sciences, Inc.1991-08-20
MITRASHEER TRANSPLANT DRESSING (K911649)Polymint Industrial Co. , Ltd.1991-08-07
DYNAVISION 2000 (K911938)Performance Ent.1991-08-02
ANATOMIC TOE SYSTEM (K911552)Orthopaedic Biosystems1991-06-28
INERPAN(TM) TEMPORARY WOUND DRESSING (K911161)Laboratories Delalande1991-06-27
SEAL-RITE SILICONE EAR PLUG (K910177)Flents Products Co., Inc.1991-06-24
MICROZYME PHENCYCLIDINE ENZYME IMMUNOASSAY TEST KT (K911153)Immunotech Corp.1991-06-18
INTRASITE HYDROCOLLOID WOUND DRESSING (K911660)Smith & Nephew United, Inc.1991-06-17
CUSA(R) SYSTEM 200C/200T/200M/200H ULTRA ASPIRATOR (K910696)Valleylab, Inc.1991-06-11
EAGLE VISION FREEMAN RADIOPAGUE PUNCTUM PLUG (K905427)Eagle Vision, Inc.1991-06-06
ACA(R) URINE PHENCYCLIDINE (U PCP) SCREEN METHOD (K911725)E.I. Dupont DE Nemours & Co., Inc.1991-06-03
LM-150HT LIGHT SOURCE (K911212)Leisegang Medical, Inc.1991-05-23
OPHTA SIL (R), PUNCTAL PLUGS AND INSERTERS (K911108)G.W.B. Intl., Ltd.1991-05-13
OPHTA SIL (R), LACHRYMAL INTUBATION SETS (K911109)G.W.B. Intl., Ltd.1991-05-01
HEXIDIS ALCOHOL SWAB (K910735)Specialites Septodont1991-04-02
MEDIFIL (K910944)Biocore1991-04-02
NORMLGEL PROTECTIVE WOUND GEL (K905438)Scott Health Care1991-04-01
GAUZE SPONGES ABSORBENT GAUZE ROLLS (K910623)Liaoning-Usa Corp.1991-04-01
COBE SPECTRA BLOOD COMPONENT SEPARATOR THERAPEUTIC (K900105)Cobe Laboratories, Inc.1991-03-22
KALTOSTAT WOUND DRESSING (K910059)Calgon Vestal Div.1991-03-20
KALTOSTAT WOUND PACKING (K910080)Calgon Vestal Div.1991-03-20
LACRIMAL PLUG (K905750)Tamcenan Corp.1991-03-14
GAUZE SPONGES, INTERNAL AND EXTERNAL (K905136)American Healthcare Corp.1991-03-06
SOLUSPONGE - S-99 (K901564)Sie Medical Supply Co., Inc.1991-02-27
ALGODERM ALGINATE WOUND DRESSING (K905314)Les Laboratorires Brothier, S.A.1991-02-19
ACCU-TEC SYSTEM FOR TISSUE EXPANDER INJECTION PORT (K905484)Mentor Corp.1991-02-11
AUTO FIRST-AID KIT FOR AMERICA (K903393)Hisler-Radke, Inc.1991-01-31
DUODERM DRESSINGS, CGF DRESSINGS, PASTE FULL THICK (K904852)Convatec, A Division of E.R. Squibb & Sons1991-01-25
SURGITEK TEX-SPAN TEXTURED TISSUE EXPANDER (K903448)Medical Engineering Corp.1991-01-14
MEDI LISS DENTAL ANALGESIA DEVICE (SBL601) (K900731)Medical Consultants Intl. , Ltd.1990-12-17
OSADA ENDEX (K904742)Osada Electric Co., Ltd.1990-12-17
COMFORTRON II (TENS) (K902948)M. D. Products1990-12-17
KALTOSTAT WOUND DRESSING (K904488)Calgon Vestal Div.1990-12-12
EMIT (R) II PHENCYCLIDINE ASSAY (K904765)Syva Co.1990-11-28
MENTOR TISSUE EXPANDERS W/TDMAC COATING (K894475)Mentor Corp.1990-11-26
SURGICAL ASPIRATOR KIT (K904010)Surgeon Surgical Instrumentation, Inc.1990-11-21
FRESENIUS AS 104 CELL SEPARATOR (K895435)Fresenius USA, Inc.1990-11-02
SELECTOR ULTRASONIC SURGICAL ASPIRATOR (K901974)Spembly Medical , Ltd.1990-09-05
MILENIA(TM) PCP (K902960)Diagnostic Products Corp.1990-08-17
MEDI-SURE, MEDI-SORB (K897180)Gulf Coast Medical, Inc.1990-08-01
BPA, BODY POSITION ALARM (K902669)Bagrad1990-07-27
L SOPHIA (K901512)Nishitomo Co., Inc.1990-07-20
SONOCA II ULTRASONIC SURGICAL DEVICE (K901737)Holl Meditronics, Inc.1990-07-03
MARTIN-HENSLEY SEGMENT LENS (K897021)Bruce W. Martin O.D. and Edward Hensley1990-06-22
INVOTEC SEPTAL BUTTON (K901366)Invotec International, Inc.1990-06-14
CARRINGTON WOUND DRESSING (K902345)Carrington Laboratories, Inc.1990-06-07
WOUND TREATMENT KIT (K901109)Orion Life Systems, Inc.1990-06-06
GREEN LABEL BIOBRANE II AND RED LABEL BIOBRANE II (K901369)Sterling Drug, Inc.1990-06-05
HYCOR ACCUPINCH PHENCYCLIDINE TEST (K900921)Hycor Biomedical, Inc.1990-04-26
TDX PHENCYCLIDINE II ASSAY (K900940)Abbott Laboratories1990-04-25
MOTIONSPECT (K895881)Baltimore Therapeutic Equipment Co.1990-04-10
BOWEN ELECTRODE SKIN PREPATORY CLEANSER (K896898)Bowen & Company, Inc.1990-04-04
LOOK TEMPORARY INTRACANALICULAR COLLAGEN IMPLANT (K897190)Look, Inc.1990-03-28
MESALT STERILE DRESSING (K897142)Scott Health Care1990-03-27
WATER JEL STERILE GEL-SOAKED BURN DRESSING (K900516)Trilling Medical Technologies, Inc.1990-03-19
OPTIKEM PMMA CONTACT LENS (K895411)Optikem Polymers, Inc.1990-02-27
ACU-BAND ACCUPRESSURE WRIST BAND (K900588)Euro-Am Pharma, Inc.1990-02-22
ADHESIVE BANDAGES & PADS FOR MINOR CUTS/SCRAPES (K893123)Les Laboratorires Brothier, S.A.1990-02-13
COMBINATION 6X-MAGNIFIER AND TWEEZERS (K896413)James Alexander Corp.1990-02-01
ABUSCREEN ONTRAK FOR PHENCYCLIDINE (PCP) (K895906)Roche Diagnostic Systems, Inc.1990-01-26
HERRICK LACRIMAL PLUG TM. (K896175)Lacrimedics, Inc.1990-01-22
CUSA SYSTEM 200C,T,M,H ULTRASONIC ASPIRATOR (K894600)Valleylab, Inc.1990-01-19
WOUND DRESSING (K896702)Viaderm Pharmaceuticals, Inc.1990-01-19
SURGITEK(R) EXTERNAL FILL PORT (K894495)Surgitek1990-01-17
OPTISOL (K894162)Chiron Ophthalmics1990-01-12
ALCOHOL PREP AND POVIDONE-IODINE PREP (K896835)Norpak Mfg., Inc.1990-01-11
SILASTIC SOFT SHEETING (K894226)Dow Corning Wright1990-01-03
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