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

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RecordFirmDate
PETIT SOPHIA (K021978)Nishitomo Co., Inc.2003-04-08
DENTAL PROTECTOR (K024261)Dental Concepts, LLC2003-03-26
DSG RELAXER SPLINT (K022627)Sentage Corporation D/B/A/ Dental Services Group2003-03-18
SILVERLEAF CONTACT WOUND DRESSING (K013936)Silverleaf Technologies, Inc.2003-03-18
ORAMAGICRX ORAL WOUND RINSE (K024180)Mpm Medical., Inc.2003-03-14
XYLOS XCELL ANTIMICROBIAL DRESSING (K024054)Xylos Corporation2003-03-07
SMEARCLEAR (K024198)Sybron Dental Specialties, Inc.2003-03-05
COOK NEPHROSTOMY DILATION BALLOON CATHETER SET (K024050)Cook Urological, Inc.2003-02-27
OLYMPUS ULTRASONIC SURGICAL SYSTEM (K021962)The Olympus Optical Co.2003-02-12
CONTREET FOAM ADHESIVE/NON-ADHESIVE (K022416)Coloplast Corp.2003-02-03
SCIVOLUTIONS VARIOUS ANTIBACTERIAL BANDAGES (K020318)Scivolutions, Inc.2003-02-03
ACTISORB SILVER 220 ANTIMICROBIAL BINDING DRESSING (K022483)Johnson & Johnson Medical, Ltd.2003-02-03
SILVERLON CONTACT WOUND DRESSING (K023612)Argentum International, LLC2003-01-24
SILVERLON ADHESIVE STRIP (K023609)Argentum International, LLC2003-01-17
HYDROFERA BACTERIOSTATIC WOUND DRESSING (K023138)Hydrofera, LLC2003-01-17
IMPULSE-ADJUSTING INSTRUMENT, CBP ADJUSTING INSTRUMENT, NEUROMECHANICAL ADJUSTING INSTRUMENT, MODELS 2003 (K023462)Neuromechanical Innovations, LLC2003-01-13
CARDIOTECH ANTIBOTIC HYDROGEL WOUND DRESSING (K022584)Cardiotech Intl.2002-12-30
ACELL UBM HYDRATED WOUND DRESSING (K022854)Acell, Inc.2002-12-30
DENTA PORT (K022147)J. Morita USA, Inc.2002-12-20
ACELL UBM LYOPHILIZED WOUND DRESSING (K021637)Acell, Inc.2002-12-19
AMEDICA DRUG SCREEN PHENCYCLIDINE TEST (K023109)Amedica Biotech, Inc.2002-12-16
GEBAUER'S INSTANT ICE (K021726)Gebauer Co.2002-12-12
COLLATEK HYDROGEL (K022995)Biocore Medical Technologies, Inc.2002-12-02
ALOCLAIR ORAL RINSE (K023155)Sinclair Pharmaceuticals, Ltd.2002-11-25
CALGITROL AG SILVER ALGINATE WOUND DRESSING (K011618)Adri2002-11-15
HEMCON BANDAGE (K023298)Hemcon, Inc.2002-11-04
REGENECARE WOUND GEL (K020540)Mpm Medical., Inc.2002-11-01
SMART PLUG, MODEL 500; SMARTPLUG FORCEPS, MODEL 502; PUSH ROD, MODEL 503 (K022043)Medennium, Inc.2002-10-18
CARRAKLENZ AND ULTRAKLENZ (K022670)Carrington Laboratories, Inc.2002-10-17
DYNAREX IODOFORM PACKING STRIPS, MODELS 3411, 3412, 3413, 3414 (K012816)Dynarex Corp.2002-10-17
MOIST PUNCTAL PLUG SYSTEM (K021936)Moist Medical, Inc.2002-10-16
FRYE ADJUSTING INSTRUMENT (K021238)Frye Health Systems2002-10-09
CONTREET-H ANTIMICROBIAL HYDROCOLLOID DRESSING, MODELS 9610 (4 X 4 (10 CM X 10CM), 9613 (6X6 (15CM X 15CM) (K013525)Coloplast Corp.2002-10-04
SELECTOR INTEGRA ULTRASONIC SURGICAL ASPIRATOR, MODEL OM 1530000M3 (K021989)Integra Neurosciences2002-09-13
AXYA MEDICAL, INC, MODEL 100 SONIC SCALPEL ULTRASONIC SURGICAL SYSTEM (K021929)Axya Medical, Inc.2002-09-10
AVAGEN WOUND DRESSING (K022127)Integra Lifesciences Corp.2002-09-10
CHITO-SEAL (K021062)Abbott Vascular, Inc.2002-08-23
ULTRASONIC STRAIGHT/ULTRASONIC KNIFE/ULTRASONIC RING CURRETTE (K020220)Synergetics, Inc.2002-08-23
BILAYER MATRIX WOUND DRESSING (K021792)Integra Lifesciences Corp.2002-08-14
CRYOBAG, MODEL CB (K021702)Origen Biomedical, Inc.2002-08-06
SHARPOINT ULTRAPLUG EXTENDED WEAR PLUG (K020882)Surgical Specialties Corp2002-07-26
MODIFICATION TO TOWNLEY TRANSFACEPEDICULAR SCREW FIXATION SYSTEM (K021705)Medtronic Sofamor Danek, Inc.2002-07-24
HEMADERM COTAINING HEMADEX CLOTTING BEADS (K021678)Medafor, Inc.2002-07-12
HEMOSORB (K021581)On Site Gas Systems, Inc.2002-07-12
JUSTWO MODEL TME-601 ROOT APEX LOCATOR (K022020)Toei Electric Co., Ltd.2002-07-02
OPAQUE HERRICK LACRIMAL PLUG, 0.3MM,0.5MM,0.7MM, MODELS HLP3-OPB,HLP50OPB,HLP7-OPB (K021831)Lacrimedics, Inc.2002-07-01
SOFT PLUG ABSORBABLE PLUG-SA (K013613)Oasis Medical, Inc.2002-06-27
ADULT SILICONE EAR PLUGS, MODELS # 68053, 68057 (K020296)Apothecary Products, Inc.2002-06-25
ABSORBENT ANTIMICROBIAL WOUND DRESSING (K013814)Convatec, A Division of E.R. Squibb & Sons2002-06-21
ACUSTIM (K014273)S.H.P. Intl. Pty., Ltd.2002-06-12
OPTAX SYSTEM (K020800)Optax Systems, Inc.2002-06-10
SS MATRIX (K020732)Cook Biotech, Inc.2002-05-30
QUICKCLOT (K013390)On Site Gas Systems, Inc.2002-05-23
LIFESIGN MET, STATUS STIK MET, ACCUSIGN STIK MET, ACCUSTIK MET, ACCUSIGN MET, STATUS DS MET (K014192)Princeton BioMeditech Corp.2002-05-23
PHENCYCLIDINE ENZYME IMMUNOASSAY, CATALOG NUMBERS 0010 & 0011 (K020254)Lin-Zhi International, Inc.2002-05-10
L.A.M. IPM WOUND GEL (K020325)L.A.M. Pharmaceutical, Corp.2002-04-15
IALUSET HYDROCOLLOID (K020041)Institut Biochimique SA (Ibsa)2002-03-14
PHENCYCLIDINE (K013096)Abbott Laboratories2002-03-13
NUVASIVE TRIAD FACET SCREW SYSTEM (K020411)Nuvasive, Inc.2002-03-12
DR. HAYS BITE GUARD (K014079)Inventive Resources, Inc.2002-02-22
PROMOGRAN MATRIX WOUND DRESSING (K014129)Johnson & Johnson Medical, Ltd.2002-02-14
PSYCHEMEDICS RIA PHENCYCLIDINE ASSAY (K011275)Psychemedics Corp.2002-02-11
PEACE OF MIND HOME DRUG TEST (K013778)Advantage Diagnostics Corp.2002-02-07
VASCULAR SOLUTIONS DUETT FLOWABLE HEMOSTAT (K012293)Vascular Solutions, Inc.2002-01-18
HYDROFERA BACTERIOSTATIC WOUND DRESSING (K013462)Hydrofera, LLC2002-01-11
SEAL-ON TOPICAL HEMPSTATIC POWDER SPRAY (K010933)Alltracel Pharma , Ltd.2002-01-08
GELCLAIR CONCENTRATED ORAL GEL (K013056)Sinclair Pharmaceuticals, Ltd.2001-12-21
MEDPOR COATED TEAR DRAIN (K012108)Porex Surgical, Inc.2001-12-19
MODIFICATION TO TOWNLEY TRANSFACETPEDICULAR SCREW FIXATION SYSTEM (K013829)Medtronic Sofamor Danek, Inc.2001-12-19
AT HOME DRUG TEST, MODEL 9074 (K013409)Phamatech, Inc.2001-12-06
AT HOME DRUG TEST, MODEL 9064 (K013410)Phamatech, Inc.2001-12-06
AT HOME DRUG TEST, MODEL 9069 (K013412)Phamatech, Inc.2001-12-06
MENTOR CONTOUR PROFILE TISSUE EXPANDER (K011500)Mentor Corp.2001-12-03
AMEDITECH IMMUTEST DRUG SCREEN PCP (K012582)Ameditech, Inc.2001-11-30
SILMED NASAL SEPTAL BUTTON (K013696)Silmed, Inc.2001-11-28
RUSCH PERCUTANEOUS NEPHROSTOMY CATHETER SETS (K011121)Rusch Intl.2001-11-16
DISCOVERY FACET SCREW FIXATION SYSTEM (K012773)Depuyacromed2001-11-16
ICE BATON (K012746)Behive, Ltd.2001-11-14
SORING GMBH SONOCA 180/190 (K012753)Soring GmbH Medizintechnik2001-11-13
ACRYDERM SILVER ANTTIMICROBIAL WOUND GEL MODEL# A-002101 (K011994)Acrymed, Inc.2001-11-08
REPROCESSED HARMONIC (K012571)Sterilmed, Inc.2001-11-07
BIOPATCH ANTIMICROBIAL DRESSING (K003229)Integra Lifesciences Corp.2001-10-26
COLLATEK SHEET (K012995)Biocore Medical Technologies, Inc.2001-10-25
COLLATEK FOAM (K012997)Biocore Medical Technologies, Inc.2001-10-25
COLLATEK POWDER (K012990)Biocore Medical Technologies, Inc.2001-10-24
THE SALICEPT ORAL PATCH (K012126)Carrington Laboratories, Inc.2001-10-03
ULTRACISION HARMONIC SCALPEL BLADES WITH PROTECTIVE SLEEVE, MODELS DH105, DH145, SH105, SH145 (K012176)Ethicon Endo-Surgery, Inc.2001-10-01
HARRISON HAND HELD ADJUSTING INSTRUMENT (K010851)Harrison Cbp Seminars2001-09-18
ACRYDERM SILVER ANTIMICROBIAL PERFORATED WOUND DRESSING (K012116)Acrymed, Inc.2001-09-12
EXCILON AMD ANTIMICROBIAL SPONGE MODEL #7088 (K011941)The Kendall Company2001-08-22
ACON PCP ONE-STEP PHENCYCLIDINE TEST STRIP, ACON PCP ONE-STEP PHENCYCLIDINE TEST DEVICE (K011730)ACON Laboratories, Inc.2001-08-09
SALIVART ORAL MOISTURIZER MODEL NUMBER 03866-009-75 SALIVART ORAL MOISTURIZER MODEL NUMBER 0386-000-25 (K981693)Gebauer Co.2001-08-06
ALLIGER ULTRASONIC SURGICAL SYSTEM MODEL AUSS-5 (K012028)Misonix, Inc.2001-07-27
LASERSKIN DRESSING (K001508)Fidia Advanced Biopolymers Srl2001-07-25
LIVESURE PHENECYCLINE (PCP) SCREEN TESTS (K012107)Pan Probe Biotech, Inc.2001-07-20
NTI TENSION SUPPRESSION SYSTEM (K010876)Nti-Tss, Inc.2001-06-20
FORTADERM WOUND DRESSING (K011026)Organogenesis, Inc.2001-06-13
ISLAND WOUND DRESSING WITH MICROBAN (K010951)Island Dressing, LLC2001-06-11
TEAM-UP TM DENTAL ELECTRONIC ANESTHESIA SYSTEM (K011001)Satelec2001-06-07
ULTRACISION HARMONIC SCALPEL BLADES, MODEL DH105,DH145,SH105, SH145,HC145 (K010898)Ethicon Endo-Surgery, Inc.2001-05-31
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