Atlas FDA

1983

3,564 FDA 510(k) clearances · Clearance year

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RecordFirmDate
CAVITY CLEANSER (K832497)Den-Mat Corp.1983-10-04
ATI FOREHEAD THERMOMETER (K832651)American Thermal Instruments, Inc.1983-10-04
WINDSOR MEDICAL MODEL 52 (K832641)Windsor Medical, Inc.1983-10-04
HEKTOEN ENTERIC AGAR PLATE (K832535)Otisville Biotech, Inc.1983-10-04
SELF CHECK DIGITAL BLOOD PRESS. MONITOR (K832171)Ritter Co.1983-10-04
EMIT AED VALPROIC ACID ASSAY (K832719)Syva Co.1983-10-04
HI-LO TEMP TYMPANIC TEMP. SENSOR (K832635)Mallinckrodt Critical Care1983-10-04
FOLATE RADIOASSAY KIT CA-1562-125 (K832712)Clinical Assays, Inc.1983-10-04
GREAT LAKES PASTE SOLDER (K832425)Great Lakes Orthodontics, Ltd.1983-10-04
BAIRD PARKER AGAR PLATE (K832524)Otisville Biotech, Inc.1983-10-04
SENSITIVE EYES (K832706)Bausch & Lomb, Inc.1983-10-04
I.V. FILTER HOLDER (K832300)Saxnor Corp.1983-10-04
ACETAMINOPHER ASSAY KIT (K832045)Quantimetrix Corp.1983-10-04
EPA AUTOMATED INFUSION POLE (K832997)Miami Eye Technology, Inc.1983-10-04
GINGI CURETTAGE DIAMOND POINTS (K832856)Shofu Dental Corp.1983-10-04
FREEMAN ACETABULAR CUP (K832958)Depuy, Inc.1983-10-04
DIRECTOR (K832658)Pharmacia, Inc.1983-10-04
MED CARE PREP RAZOR (K831374)Medcare Products1983-10-04
C-LOOPS (K830800)Concept, Inc.1983-10-04
DENTAL SYRINGE SYSTEM-VARIOUS STYLES (K832662)Centrix, Inc.1983-10-04
CHEMONUCLEOLYSIS TABLE #6100 (K832848)Kirschner Medical Corp.1983-10-04
ELECATH HEPARIN COATED THERMAL DILUTION (K832787)Electro-Catheter Corp.1983-10-04
SELENITE CYSTINE BROTH (K832533)Otisville Biotech, Inc.1983-10-04
BROOK LIFE SAVING AIRWAY DEVICE #900 & (K832435)La Societe Fianciere Senefin1983-10-04
SHEEP BLOOD AGAR PLATE (K832534)Otisville Biotech, Inc.1983-10-04
DIXIE USA PTL, PHARYNGEAL TRACHEAL LUMEN (K831481)Eugene Scarberry1983-10-04
ELECTRONIC UNIT (K832887)Surgi-Quip Inc.U1983-10-04
TRYPTOSE SULFITE CYCLOSERINE AGAR PLATE (K832523)Otisville Biotech, Inc.1983-10-04
ARTHROSCOPE-VARIOUS MODELS FIBEROPTIC (K832341)Kamiya Tsusan Kaisha, Ltd.1983-10-04
VIBRATORY ENDODONTIC SYSTEM (K832378)Syntex Dental Products, Inc.1983-10-04
PSI SURGICAL ASPIRATOR (K832100)Advanced Biosearch Assn.1983-10-04
LYPHOCHEK SERUM REF. STANDARD-BOVINE (K832695)Bio-Rad1983-10-04
MILLIPORE IVEX INT FILTER UNIT (K832952)Millipore Corp.1983-10-04
QUICK-TELL INDIRECT PREGNANCY TEST (K832640)Stanbio Laboratory1983-10-04
VITAMIN B12 RADIOASSAY KIT CA-1534 (K832710)Clinical Assays, Inc.1983-10-04
ENCORE CHEMISTRY ANALYZER (K832716)Baker Instructions Corp.1983-10-04
ATRIUM THORACIC CATHETER (K831931)Atrium Medical Corp.1983-10-04
MICRO TRAK CHLAMYDIA TRAC CONTROL SLID (K832078)Syva Co.1983-09-29
DIACROM * HEPARIN (K832373)Wellcome Diagnostics1983-09-29
ECT PROCESSOR (K832737)Siemens Gammasonics, Inc.1983-09-29
HEPARIN COATED STAINLESS STEEL/TEFLON (K832030)Argon Medical Corp.1983-09-29
MIDAS 6000 AUTOMATIC STAINER (K832994)Innovative Medical Systems, Inc.1983-09-29
SHILEY GAS FILTER (K832704)Shiley, Inc.1983-09-29
REXTON RX10, RX20-30 & 40 (K832180)Rexton, Inc.1983-09-29
HEYER-SCHULTE AFTERLOADING CATHETER (K832738)American Heyer Schulte1983-09-29
FOGARTY 6MM SOFTJAW CLIP (K832554)American Edwards Laboratories1983-09-29
MMS ACETABULAR CUPS (K830361)3M Company1983-09-29
COLLECTION KIT CHLAMYDIA TRACHOMATIS (K832079)Syva Co.1983-09-29
DIACROM * FACTOR X KIT HA31 (K832372)Wellcome Diagnostics1983-09-29
KEMTEK 104 RIA GAMMA COUNTER (K832736)Kemble Instruments, Inc.1983-09-29
LUCAE'S EAR & NASAL APPLICATORS (K832667)Kells Medical, Inc.1983-09-29
PATIENT MONITOR #78353A (K831787)Hewlett-Packard Co.1983-09-29
ABBOTT GLOBE HOLDER (K832911)Miami Eye Technology, Inc.1983-09-29
TPE DIAMOND POINTS (K832855)Shofu Dental Corp.1983-09-29
WIDEX HEARING AID MODEL L1 (K832376)Widex Hearing Aid Co., Inc.1983-09-29
RADIOTHERAPY MGMT. SYSTEM RMS-1000 (K832732)Varian Assoc., Inc.1983-09-29
ELASTOPLAST T.P.N. (K831439)Beiersdorf, Inc.1983-09-29
AFTER LOADING BUCHLER (K832789)Ellis Pharmaceutical Consulting, Inc.1983-09-29
BASIC BREAST PUMP (K831929)Terayco Intl., Ltd.1983-09-29
LIGHT HANDLE COVER (K832278)Concept, Inc.1983-09-29
FOGARTY-CHIN PERIPHERAL DILATION CATH (K832474)American Edwards Laboratories1983-09-29
CARDIO-SCOPE MINI MONITOR (K831878)W.E. Leder Enterprises, Inc.1983-09-29
CONCISE 2 SMALL PARTICLE LIGHT CURVED (K832834)3M Company1983-09-29
MUCICARMINE STAIN, #HT30 (K832953)Sigma Chemical Co.1983-09-29
AMES TDA DISOPYRAMIDE TEST (K832766)Miles Laboratories, Inc.1983-09-29
SHILEY MULTIPRO CATHETER (K832044)Shiley, Inc.1983-09-29
HARD CONTACT LENS CLEANER (K832810)Blairex Laboratories, Inc.1983-09-29
FUKUNDA SANGYA UNITS PULMOTESTER PM60 (K832431)Future Impex Corp.1983-09-29
BLAISE-RATHAEL VOICE PROSTHESIS (K832852)Richards Medical Co., Inc.1983-09-29
DEVA 4 (K832530)Degussa Dental, Inc.1983-09-29
LARYNGESCOPE (K831981)W.E. Leder Enterprises, Inc.1983-09-29
PZ-800 VOLUME VENTILATOR (K822835)Narco Scientific1983-09-29
RISTOCETIN PLATELET AGGREGA-REAGENT TEST (K832929)Sigma Chemical Co.1983-09-29
KEMTEK 103 RIA GAMMA COUNTER (K832735)Kemble Instruments, Inc.1983-09-29
FLYNN SERIES III BAG/MASK UNIT- (K832495)O-Two Systems Intl., Inc.1983-09-29
FUKUNDA SANGYO UNITS ELECTRONIC SPIRO (K832430)Future Impex Corp.1983-09-29
SINGLE PATIENT SYS. II MODEL DM-450 (K832053)Extracorporeal Medical Specialities, Inc.1983-09-29
H-FLU B ELISA TEST (K831525)Seragen Diagnostics, Inc.1983-09-29
INTRINSIC FACTOR BLOCKING ANTIBODY KIT (K832726)Diagnostic Products Corp.1983-09-29
CONTROL 282 (K832066)Bio-Nustics, Inc.1983-09-29
XEROX 120 SYS MAMMOGRAPHIC X-RAY (K832733)Xerox Medical Systems1983-09-29
ANSPACH 65,000 (K831756)The Anspach Effort, Inc.1983-09-29
A-GENT GLYCOSYLATED HEMOGLOBIN (K832775)Abbott Laboratories1983-09-29
AUTOMATIC TANGENT SCREEN 50 (K832800)CooperVision, Inc.1983-09-29
PEDAL EXERCISER (K832968)Maddak, Inc.1983-09-29
BEHIND-THE-EAR #123 AGCI (K832326)Danavox, Inc.1983-09-29
NYC-GC MEDIA (K832948)Otisville Biotech, Inc.1983-09-29
DISPOSABLE VITRECTOMY HANDPIECE (K832235)Innovative Surgical Products, Inc.1983-09-29
HSI ELITE #EC CUSTOM CANAL HEAR-AID (K832701)Hearing Services, Inc.1983-09-29
DIACROM * ATIII (K832592)Wellcome Diagnostics1983-09-29
BACTEROIDES BILE ESCULIN AGAR (K832955)Bd Becton Dickinson Vacutainer Systems Preanalytic1983-09-29
RUBY KNIVES FOR OPHTH. SURGERY (K832844)Keeler Instruments, Inc.1983-09-29
AMES TDA SISOMICIN TEST-CONTROL SERUM (K832792)Miles Laboratories, Inc.1983-09-29
THYROID PROTECTIVE COLLAR (K832602)E.M. Adams1983-09-29
FLOW-DIRECTED HEPARIN COATED THERMODIL (K832957)Sorensen Research1983-09-29
BEHIND-THE-EAR SERIES 125 (K832751)Danavox, Inc.1983-09-29
CANE REACHER (K832970)Maddak, Inc.1983-09-29
MICRO TRAK CHLAMYDIA TRACHOMATIS DIRECT (K832077)Syva Co.1983-09-29
DOSIMETRIC RELEASE OF GAMMA RADIATION (K832211)Kirschner Medical Corp.1983-09-29
ORTHO CELL CULTURES-MRC-5 HUMAN EMBRYO (K832947)Ortho Diagnostic Systems, Inc.1983-09-29
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Every clearance here is in the API, with alerts when new ones post.