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32,815 FDA 510(k) clearances · Device class

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RecordFirmDate
ULTIMATE SEAL (K960401)Hans Rudolph, Inc.1996-06-20
IOVES,CORTINA CLUB EYEWEAR,LOUTTESRLG5 (K962107)Leonachi, Inc.1996-06-20
LYOFOAM EXTRA C ODOR ABSORBING WOUND DRESSING (K961323)Acme United Corp.1996-06-19
AMO PHACOFLEX II INTERSECTION SYSTEM (K961242)Allergan, Inc.1996-06-17
AUTOMATIC VISUAL FIELD PLOTTER AP-125 (K961090)Kowa Optimed, Inc.1996-06-17
COLISCREEN (K961191)Hardy Diagnostics1996-06-17
ACS FRT4 IMMUNOASSAY (K961510)Ciba Corning Diagnostics Corp.1996-06-17
VIRAZYME CULTURE CONFIRMATION SCREEN FOR INFLUENZA AND PARAINFLUENZA VIRUSES (K950838)Zymetx, Inc.1996-06-17
COMPLEMENT CONTROL (K960874)Wako Chemicals USA, Inc.1996-06-14
ELECSYS 2010 ANALYZER (K961481)Boehringer Mannheim Corp.1996-06-14
QUALICHECK 4 METABOLITE(S3630,S3640,S3650,S3660) (K961354)Radiometer America, Inc.1996-06-14
FIRST CHOICE KETONES URINE TEST STRIPS (K953662)Polymer Technology Intl.1996-06-14
MULTICHECK (K961355)Radiometer America, Inc.1996-06-14
HORIZON DIAGNOSTICS TRIGLYCERIDES-GPO REAGENT (K933722)Horizon Diagnostics, Inc.1996-06-13
ADVANCED CARE HYDROPHILIC WOUND DRESSINGS (K961662)Mariner Biomedical, Inc.1996-06-13
CEMENT AND BONE REMOVAL KIT (K961759)Maillefer Instruments S.A.1996-06-13
FIRST CHOICE GLUCOSE & KETONES URINE TEST STRIPS (K953680)Polymer Technology Intl.1996-06-12
PORTA'PURE/DENTAL (K961409)Water Solution Technologies1996-06-12
CLINITEK 50 URINE CHEMISTRY ANALYZER (K960546)Bayer Corp.1996-06-12
SPINAL TOUCH (K961212)Fasstech1996-06-12
UPACS VERSION 1.7 (K961160)Base Ten Systems, Inc.1996-06-11
LIQUICHEK CARDIAC MARKERS CONTROL (CAT. NO. 685,686,687,688) (K961828)Bio-Rad1996-06-11
OSTAR EXAMINATION GLOVES (K955947)Contract Latex Dippers Sdn Bhd1996-06-10
OSTAR (K955424)Ultravena Industries, Ltd.1996-06-10
TONGUE SCRAPPER (K961574)U.S. Dentek Corp.1996-06-10
ASEPTYLUM, UNI-CARRIER (K961714)Distriflor S.A.1996-06-10
KODAK DIGITAL SCIENCE(KDS) MEDICAL IMAGE AND INFORMATION LIBRARY (K960981)Kodak Health Imaging Systems, Inc.1996-06-07
FLEXSURE HP,CONTROLS FOR FLEXSUREHP,FLEXPACK HP(ABBOTT DIAGNOSTICS)ANDCONTROLS FOR FLEXPACK HP (ABBOTT DIAGNOSTICS) (K960183)Smithkline Diagnostics, Inc.1996-06-07
NON-PRESCRIPTION SUNGLASSES (K961990)Rokko Stars Co., Ltd.1996-06-06
BAXTER SODIUM ACETATE INFANT HEEL WARMER (K961154)Baxter Healthcare Corp1996-06-06
GLOVE SEAL & SET-RITE (K954063)Contract Latex Dippers Sdn Bhd1996-06-05
QUANTEC SERIES 2000 ENDODONTIC FILES (K962031)Tycom Dental1996-06-04
U-DOA CONTROLS (K961724)Medical Diagnostic Technologies, Inc.1996-06-03
UPACS (K960941)Base Ten Systems, Inc.1996-06-03
SUNGLASSES (K961146)Erica Optical Co.1996-05-31
TONGUE CLEANER (K961660)Jack Conrey1996-05-31
ACTICOAT SILVER COATED DRESSING (K955453)Westaim Technologies, Inc.1996-05-31
SUNGLASSES (K960953)Galilee Optics1996-05-31
MISTRAL SUNGLASSES (K960668)Mistral Optical1996-05-31
SUNGLASSES (K960818)Visard Srl1996-05-31
CLOSED FLUID COLLECTION SYSTEM (K961147)B.Braun Medical, Inc.1996-05-31
LYOFOAM EXTRA 'A' STERILE ADHESIVE WOUND DRESSING (K961452)Acme United Corp.1996-05-31
LARYNGOSCOPE COVER (K945301)Sotiria Mourkidou, M.D.1996-05-31
BREATHE RIGHT NASAL STRIP (K955711)Cns, Inc.1996-05-30
H292 CELL CULTURE (K960909)Neogenex1996-05-30
GASTRIN EIA MODEL 06B-555017 (K961276)Biosyn , Ltd.1996-05-30
IMX SELECT CHLAMYDIA (K936054)Abbott Laboratories1996-05-30
MICROSCAN RAPID GRAM-NEGATIVE INDENTIFICATION TYPE 3 PANEL (K961042)Dade Microscan, Inc.1996-05-30
NETRA WORKSTATION SYSTEM & NETRA MD SOFTWARE (K960911)Scimage, Inc.1996-05-29
ECLIPSE 600 MANUALLY OPERATED WHEELCHAIR (K961743)Pdg Product Design Group, Inc.1996-05-29
ARGOSY PROGRAMMABLE (K961729)Argosy Electronics1996-05-29
PHONAK SONA P2 (K961653)Phonak, Inc.1996-05-29
HIGH RISK GLOVES (K955241)Pan-Century Rubber Products Sdn. Bhd.1996-05-28
POWDER FREE LATEX EXAMINATION GLOVE (K960467)Biopro, Inc.1996-05-24
GREEN TEC-2100 (K955236)Medtec, Inc.1996-05-24
EKTACHEM DT LDL CHOLESTEROL KIT (K955904)Johnson & Johnson Clinical Diagnostics, Inc.1996-05-24
NCI-H292 CELL CULTURE (K951461)Viromed Laboratories, Inc.1996-05-22
JACKSON-PRATT GOLD WOUND DRAINS WITH DURAFLO II COATING (K960955)Baxter Healthcare Corp1996-05-22
LLC-MK2 (MONKEY KIDNEY, MACACA MULATA) CELL CULTURE (K951440)Viromed Laboratories, Inc.1996-05-22
BACTEC(R) 9000TB SYSTEM (K946268)Becton Dickinson Diagnostic Instrument Systems1996-05-21
HELISAL RAPID BLOOD TEST (K953686)Cortecs, Ltd.1996-05-21
PHONAK PICONET2 P2 AZ (K961622)Phonak, Inc.1996-05-17
CYTOQUANT VIRAL TRANSPORT MEDIUM (K961756)Proteins Intl., Inc.1996-05-17
CYTOQUANT CHLAMYDIA TRANSPORT MEDIUM (K961755)Proteins Intl., Inc.1996-05-17
CHRONOSWISS,BALENO,BONIA,OTMAR ALT, NEW JERSEY (K961746)Eurotrends Eyewear, Inc.1996-05-16
STUSSY SUNGLASSES/A.J. MORGAN SUNGLASSES (K961286)Intl. Optical Mfg. Co., Ltd.1996-05-16
SPECTACLE FRAMES/SUNGLASSES (K954419)Ami Fashion1996-05-16
STERILAB CANNULAS, STERILAB CYSTOTMES, STERILAB NEEDLES AND STERILAB LENS MANIPULATORS (K961524)Sterilab, Inc.1996-05-16
ACTIVE ULTRA-SENSITIVE UNCONJUGATED ESTRIOL (K955356)Diagnostic Systems Laboratories, Inc.1996-05-15
PROTECTIVE LATEX POWDERED GLOVES (K960277)Highactive Sdn. Bhd.1996-05-15
RNS STERILE, DISPOSABLE DIGITAL ANGIOGRAPHIC TRAY (K955689)Contour Fabricators of Florida, Inc.1996-05-15
CHEM-CHEX STAT (K961195)Streck Laboratories, Inc.1996-05-15
NEOLON NEOPRENE SURGICAL GLOVES (K954325)Maxxim Medical1996-05-14
AUTOMATED ANALYSIS ASSAY FOR BILIRUBIN IN URINE (K951877)Chimera Research & Chemical, Inc.1996-05-14
CLARITY (K961670)Seig Technologies, Inc.1996-05-14
PHEM-CHEK (K960648)Femtek, Inc.1996-05-13
ELECTROLYTE STANDARDS (K960592)Phoenix Diagnostics, Inc.1996-05-13
TINY TOON SUNGLASSES & CABBAGE PATCH KIDS SUNGLASSES (K961523)Dorda Toys1996-05-13
SUN CLIP (K961603)Intromark, Inc.1996-05-13
EVERGLORY SUNGLASSES (K960735)Everglory Creations, Inc.1996-05-13
SMARTMIST ASTHMA MANAGMENT SYSTEM, SMARTMIST, MODEL NUMBER SM-100/SMARTMIST SPIROMETRY AIRWAY, MODEL NUMBER SA-100 (K960593)Aradigm Corp.1996-05-10
SYNCHRON SYSTEMS IRON (FE)/TOTAL IRON BINDING CAPACITY REAGENTS (K960485)Beckman Instruments, Inc.1996-05-10
TRACHLIGHT STYLET & TRACHEAL LIGHTWAND (ORIGINAL APPLICATION NAME: STYLETT & TRACHEAL LIGHTWAND) (K954771)Laerdal Medical Corp.1996-05-09
MINIGUARD (K954215)Advanced Surgical Intervention, Inc.1996-05-08
BACSTOP DENTAL ANTI-RETRACTION CHECK VALVE (K960556)Scitech Solutions, Inc.1996-05-08
TECHNA TONE (K961082)Techna Tone1996-05-07
DIGIFOCUS COMPACT (K961059)Oticon, Inc.1996-05-07
COMFORTONE PHS (K960741)Comfortone America'S Value Hearing Aid Line1996-05-07
AUDIO 'D' INTIMA CIC (K961308)Hearing Solutions, Inc.1996-05-07
BCW ADVANTAGE WHEELCHAIR (K961514)Wheelchairs of Kansas1996-05-07
ACUMED BONE GRAFT SYSTEM (K960711)Acu Med, Inc.1996-05-07
TELEX SELECT 2-40 WITH ADAPTIVE COMPRESSION S2-40 (K961143)Telex Communications, Inc.1996-05-07
COMFIT BROWN, BEADED SURGEON'S GLOVES (POWDERED, HYPOALLERGENIC) (K960178)Wembley Rubber Products (M) Sdn Bhd1996-05-06
CERTI COOL INSTANT COLD COMPRESS (K960624)Certified Safety Mfg., Inc.1996-05-06
POLYMER COATED CHLORINATED POWDER-FREE LATEX EXAMINATION GLOVES (K954221)Hartalega Sdn Bhd1996-05-03
QUIKCHECK UNASSAYED CHEMISTRY CONTROL LEVELS 1 & 2 (K961293)Consolidated Technologies, Inc.1996-05-02
ENA-C-T TOTAL CHOLESTEROL TEST (K960377)Actimed Laboratories, Inc.1996-05-02
KETOREX C SANWA (K953452)Ihara Medics U.S., Inc.1996-05-02
STC DIAGNOSTICS AUTO-LYTE PH ASSAY (K954158)Solarcare Technologies Corp,Inc.1996-04-30
TONOMETERED SLAINE BLOOD GAS CONTROL (K961441)Instrumentarium Corp.1996-04-30
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