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

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RecordFirmDate
ALOCLAIR ORAL SPRAY (K042722)Sinclair Pharmaceuticals, Ltd.2005-01-13
ONLINE DAT PHENCYCLIDINE PLUS (K043305)Roche Diagnostics Corp.2005-01-10
HARMONIC ACE CURVED SHEARS WITH HAND CONTROL, MODEL ACE23P, ACE36P (K042777)Ethicon Endo-Surgery, Inc.2004-12-01
MEDTRADE PRODUCTS ANTISEPTIC BARRIER SILVER FOAM DRESSING, MODEL 09912450 (K033732)Medtrade Products , Ltd.2004-12-01
EZY-TRAVEL WRISTBAND (K041766)Apothecary Products, Inc.2004-11-26
MUCOTROL CONCENTRATED ORAL GEL WAFER (K042400)Belcher Pharmaceuticals, Inc.2004-11-24
SELF RETAINING BICANALICULUS INTUBATION SET (K041869)Fci Ophthalmics, Inc.2004-11-18
HYDROGEL CANALICULAR PLUG (K040912)Partners IN Biomaterials, Inc.2004-11-16
3M TEGADERM SILVER (K040890)3M Company2004-11-02
SELECT FABRICATORS, INC., AGMED TEX WOUND DRESSING (K040518)Select Fabricators, Inc.2004-10-27
COLLAGEN-ORC ANTIMICROBIAL MATRIX (K033523)Johnson & Johnson Medical, Ltd.2004-10-21
ACU-STRAP MOTION SICKNESS BAND (K041877)Health Ent., Inc.2004-10-08
SELECTOR QUANTUM ULTRASONIC ASPIRATOR SYSTEM (K042277)Integra Neurosciences, Ltd.2004-09-29
SILVERSITE OR CALGITROL (K041268)Adri2004-09-20
TWIN STAR COMPARTMENT SYNDROME PRESSURE MONITORING AND FLUID COLLECTION CATHETER SYSTEM (K041771)Twin Star Medical, Inc.2004-09-14
QUICKSCREEN, MODELS 9177X AND 9178X (K041578)Phamatech2004-09-10
SONOSURG ULTRASONIC SURGICAL SYSTEM (K041566)Aomori Olympus Co., Ltd.2004-09-08
ABRAM'S MULTI-DENSITY POLYURETHANE FOAM WOUND DRESSING SYSTEM (K033164)Dr. Len'S Medical Products, LLC2004-09-07
OASIS DRY MOUTH RELIEF DISCS OR OASIS MOUTH MOISTURIZING DISCS (K041563)Glaxosmithkline Consumer Healthcare, L.P.2004-08-27
MYOHEALTH CLENCHING INHIBITOR (K040315)Mci-Myohealth Systems2004-08-27
SILVER FOAM WOUND DRESSING (K032742)Advanced Medical Solutions, Ltd.2004-08-16
HEALICOLL (K040314)Encoll Corp.2004-08-12
STIMULEN COLLAGEN (K030774)Southwest Technologies, Inc.2004-08-09
ANTIMICROBIAL ALGINATE DRESSING (K041316)Advanced Medical Solutions, Ltd.2004-08-05
SILVERSEAL (K033587)Noble Fiber Technologies2004-08-05
AOC BONE WAX (K041363)Ceremed , Inc.2004-07-27
SILVERSEAL (K040019)Noble Fiber Technologies2004-07-23
INTELIPORT OCCLUDING DEVICE (K040231)Alcon, Inc.2004-07-13
SUILE OINTMENT WOUND DRESSING (K041013)Hedonist Biochemical Technologies Co., Ltd.2004-07-07
QBTEST (K040894)Qbtech AB2004-06-22
MEDICINAL LEECHES (K040187)Ricarimpex Sas2004-06-21
ALOCLAIR ORAL GEL (K040950)Sinclair Pharmaceuticals, Ltd.2004-06-21
STAY-PUT IMPREGNATED (K041023)Coltene/Whaledent GmbH & Co. KG2004-06-15
BIODERM SCIENCES WOUND DRESSING (K040683)Bioderm Sciences, Inc.2004-06-04
SENSITIVE SKIN ANTIBACTERIAL BANDAGES (K032983)Scivolution, Inc.2004-06-01
CONTREET FOAM CAVITY DRESSING WITH SILVER, MODEL 9628 (2X4 IN.) (K033869)Coloplast Corp.2004-05-17
NEPTUNE PAD, NEPTUNE DISC, NEPTUNE COMFORT-BAND, COMFORT-BAND (K040208)Tz Medical, Inc.2004-05-11
COLLAGEN WOUND DRESSING - ORAL (K040403)Collagen Matrix, Inc.2004-05-10
KENDALL ULTEC PRO AG+ HYDROCOLLOID DRESSING (K033453)Tyco Healthcare2004-04-29
ACCU-STAT HOME DRUG TESTS FOR MARIJUANA (THC) AND FOR MARIJUANA & COCAINE (THC, COC) (K040327)Accu-Stat Diagnostics, Inc.2004-04-19
TENDERWET ACTIVE (K040517)Medline Industries, Inc.2004-03-25
MODIFICATION TO: COLLAGEN TOPICAL WOUND DRESSING (K040558)Collagen Matrix, Inc.2004-03-17
VASCULAR SOLUTIONS D-STAT DRY 3X3 HEMOSTATIC PAD (K040510)Vascular Solutions, Inc.2004-03-17
GEBAUER'S SKIN REFRIGERANT (MIST STREAM), GEBAUER'S SKIN REFRIGERANT (STREAM SPRAY), MODELS P/N 0386-0010-07 (K032671)Gebauer Co.2004-03-17
TOPSEAL HEMOSTATIC DRESSING, MODEL 11150 (K033291)Radi Medical Systems AB2004-03-17
APEX NRG (K032743)Medicnrg , Ltd.2004-03-15
CLO-SURPLUSP.A.D. (K032986)Scion Cardio-Vascular, Inc.2004-03-01
MODIFICATION TO: COLLAGEN TOPICAL WOUND DRESSING (K040211)Collagen Matrix, Inc.2004-02-27
VASCULAR SOLUTIONS D-STAT DRY HEMOSTATIC BANDAGE, THE D-STAT RADIAL HEMOSTATIC BAND AND THE D-STAT 2 DRY HEMOSTATIC (K040118)Vascular Solutions, Inc.2004-02-12
CURAD SILVER BANDAGE (K032463)Beiersdorf AG2004-02-10
CURAD SILVER ACTIVE GEL BANDAGE (K032462)Beiersdorf AG2004-02-10
MEDISISS REPROCESSED ULTRASONIC SURGICAL INSTRUMENTS (K030598)Medisiss2004-01-23
ENDOPURE ROOT CANAL CLEANSER (K032361)Dentsply Intl.2004-01-12
MEDICAL MAGGOTS (K033391)Ronald A. Sherman2004-01-12
SEA-BAND (K033268)Sea-Band UK , Ltd.2004-01-07
VASCULAR SOLUTIONS D-STAT 2 DRY HEMOSTATIC BANDAGE (K033709)Vascular Solutions, Inc.2003-12-18
HEMADERM (K033666)Medafor, Inc.2003-12-17
LOTUS (K032424)Sra Developments, Ltd.2003-12-16
EUSOL-C (K032422)Al.Chi.Mi.A2003-12-15
MISONIX INC. FS 1000 RF ULTRASONIC SURGICAL ASPIRATOR SYSTEM (K032690)Misonix, Inc.2003-12-09
ASEPTICO ENDOPEX V, MODEL AEU-40 (K030895)Aseptico, Inc.2003-12-03
CAPHOSOL (K030802)Inpharma A.S.2003-11-25
ULTRADENT CITRIC ACID 10% SOLUTION (K032627)Ultradent Products, Inc.2003-11-12
TOPKIN WOUND DRESSING (K031684)Biomet Merck GmbH2003-10-30
MONARCH 21 PENILE PLETHYSMOGRAPH SYSTEM (K033126)Behavioral Technology, Inc.2003-10-29
FERRIS POLYMEM SILVER WOUND DRESSING (K031307)Ferris Mfg. Corp.2003-10-22
EZ SPLINT & EZ SPLINT PM (K022809)Power Products, Inc.-Splintek2003-10-17
SONOSURG SYSTEM (K032066)The Olympus Optical Co.2003-10-03
OLYMPUS ULTRASONIC SURGICAL SYSTEM (K031523)Aomori Olympus Co., Ltd.2003-10-01
DRESSSKIN (K023778)Tei Biosciences, Inc.2003-09-29
RAYCELL (K032684)Mds Nordion2003-09-26
OLYMPUS ULTRASONIC SURGICAL SYSTEM (K031305)Olympus Optical Co., Ltd.2003-09-23
D-STAT-DRY HEMOSTATIC BANDAGE; D-STAT RADIAL HEMOSTATIC BANDAGE (K030836)Vascular Solutions, Inc.2003-09-17
PRIMOSPLINT SYSTEM (K030832)Cosmedent, Inc.2003-09-17
BECKER TRANSNASAL LACRIMAL (INTUBATION SETS) (K023758)Fci Ophthalmics, Inc.2003-09-17
SALINUM, ORCLAIR (K024148)Sinclair Pharmaceuticals, Ltd.2003-09-15
MICROLIFE DIGITAL BASAL THERMOMETER, MODEL MT 1921 (K030961)Microlife Corp.2003-09-12
OLYMPUS ULTRASONIC SURGICAL SYSTEM (K031710)Aomori Olympus Co., Ltd.2003-08-29
STRYKER SPINE OASYS BONE SCREW (K031657)Howmedica Osteonics Corp.2003-08-22
MEDTRADE PRODUCT'S ANTISEPTIC BARRIER HYDROGEL DRESSINGS (K022587)Medtrade Products , Ltd.2003-08-22
CRYOTRON 2 CRYOTHERAPY DEVICE (K030281)Cryonic Medical North America2003-08-20
SINCLAIR WOUND AND SKIN EMULSION (K024367)Sinclair Pharmaceuticals, Ltd.2003-07-28
GEBAUER'S SKIN REFRIGERANT (MIST SPRAY), MODEL P/N 0386-0010-07, GEBAUER'S SKIN REFRIGERENT (MEDIUM SPRAY), MODEL P/N-03 (K031036)Gebauer Co.2003-07-10
SUILE WOUND DRESSING (K022967)Hedonist Biochemical Technologies Co., Ltd.2003-07-08
SYNTHES (USA) COMPARTMENTAL PRESSURE MONITORING SYSTEM (K031555)Synthes (Usa)2003-07-08
ANTIMICROBIAL ALGINATE DRESSING (K024298)Advanced Medical Solutions, Ltd.2003-06-30
HEMCON BANDAGE OTC; HEMCON CATH/AID (K030946)Hemcon, Inc.2003-06-19
CP MEDICAL BONE WAX (K024372)Cp Medical2003-06-19
APTUS BLUE (K030884)Acadental2003-05-27
COLLAGEN TOPICAL WOUND DRESSING (K030921)Collagen Matrix, Inc.2003-05-15
OPAQUE HERRICK LACRIMAL PLUG (K030300)Lacrimedics, Inc.2003-05-09
MONOCANALICULAR STENTS, LACRIMAL INTUBATION SETS (K030353)Eagle Vision, Inc.2003-04-25
T-SCIENTIFIC T-PAD (K030334)T-Scientific, Inc.2003-04-21
AT HOME DRUG CUP, MODEL 9150X (K030447)Phamatech2003-04-14
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
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