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

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RecordFirmDate
HANDY IIM (K833039)Shofu Dental Corp.1983-10-04
SUMMA DISK (K833038)Shofu Dental Corp.1983-10-04
SANODENT DOUBLE-ENDED INTERDENTAL CLEAN (K832949)Coopercare, Inc.1983-10-04
HEKTOEN ENTERIC AGAR PLATE (K832535)Otisville Biotech, Inc.1983-10-04
BAIRD PARKER AGAR PLATE (K832524)Otisville Biotech, Inc.1983-10-04
I.V. FILTER HOLDER (K832300)Saxnor Corp.1983-10-04
GINGI CURETTAGE DIAMOND POINTS (K832856)Shofu Dental Corp.1983-10-04
C-LOOPS (K830800)Concept, Inc.1983-10-04
DENTAL SYRINGE SYSTEM-VARIOUS STYLES (K832662)Centrix, Inc.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
ELECTRONIC UNIT (K832887)Surgi-Quip Inc.U1983-10-04
TRYPTOSE SULFITE CYCLOSERINE AGAR PLATE (K832523)Otisville Biotech, Inc.1983-10-04
VIBRATORY ENDODONTIC SYSTEM (K832378)Syntex Dental Products, 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
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
COLLECTION KIT CHLAMYDIA TRACHOMATIS (K832079)Syva Co.1983-09-29
KEMTEK 104 RIA GAMMA COUNTER (K832736)Kemble Instruments, Inc.1983-09-29
LUCAE'S EAR & NASAL APPLICATORS (K832667)Kells Medical, Inc.1983-09-29
TPE DIAMOND POINTS (K832855)Shofu Dental Corp.1983-09-29
WIDEX HEARING AID MODEL L1 (K832376)Widex Hearing Aid Co., Inc.1983-09-29
ELASTOPLAST T.P.N. (K831439)Beiersdorf, Inc.1983-09-29
BASIC BREAST PUMP (K831929)Terayco Intl., Ltd.1983-09-29
MUCICARMINE STAIN, #HT30 (K832953)Sigma Chemical Co.1983-09-29
LARYNGESCOPE (K831981)W.E. Leder Enterprises, Inc.1983-09-29
KEMTEK 103 RIA GAMMA COUNTER (K832735)Kemble Instruments, Inc.1983-09-29
CONTROL 282 (K832066)Bio-Nustics, Inc.1983-09-29
ANSPACH 65,000 (K831756)The Anspach Effort, Inc.1983-09-29
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
HSI ELITE #EC CUSTOM CANAL HEAR-AID (K832701)Hearing Services, Inc.1983-09-29
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
THYROID PROTECTIVE COLLAR (K832602)E.M. Adams1983-09-29
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
ORTHO CELL CULTURES-MRC-5 HUMAN EMBRYO (K832947)Ortho Diagnostic Systems, Inc.1983-09-29
DULBECCOS MODIFIED EAGLES MEDIUM D5648 (K832842)Sigma Chemical Co.1983-09-29
SPINNER SALT SOLUTION S-6011 W/EARLES (K832930)Sigma Chemical Co.1983-09-29
NUTRIENT MIXTURE F12 #N6760 W/L-GLUTAM (K832841)Sigma Chemical Co.1983-09-29
LEADED X-RAY APRON (K832601)E.M. Adams1983-09-29
V AGAR (K832954)Bd Becton Dickinson Vacutainer Systems Preanalytic1983-09-29
DULBECCOS PHOSPHATE BUFFERED SALINE (K832835)Sigma Chemical Co.1983-09-29
BASAL MED. #B9763 W/HANKS SALTS W/L-G (K832836)Sigma Chemical Co.1983-09-29
AGAR PLATE XLD (K832532)Otisville Biotech, Inc.1983-09-29
WALKING CANE (K832969)Maddak, Inc.1983-09-29
UNIVERSAL VOL. VENTILATOR 72 #1626 (K832681)Hudson Oxygen Therapy Sales Co.1983-09-26
DUPONT ISOLATOR 1.5 MICROBIAL TUBE (K832246)E.I. Dupont DE Nemours & Co., Inc.1983-09-26
DIRECTIGEN GROUP B STREP TEST KIT-SERUM (K831991)Bd Becton Dickinson Vacutainer Systems Preanalytic1983-09-26
EARLES BALANCED SALT MIXTURE #E6132 (K832838)Sigma Chemical Co.1983-09-26
ORAL SAFE (K832359)Great Lakes Orthodontics, Ltd.1983-09-26
NUTRIENT MIXTURE F-10 #N6635 W/L-GLUTA (K832837)Sigma Chemical Co.1983-09-26
SELECTRO-DISC (K832436)Lab Ability, Inc.1983-09-26
HEATED GUTTA PERCHA DELIVERY SYSTEM (K832654)Unitek Corp.1983-09-26
MINIMUM ESSENTIAL MED. EAGLE M4642 W/ (K832840)Sigma Chemical Co.1983-09-26
DRAVON T CLAMP (K831842)Dravon Medical, Inc.1983-09-26
HANKS BALANCED SALT MIXTURE H6136 (K832839)Sigma Chemical Co.1983-09-26
ZOLLER BURNED LIP CONFORMER (K832366)Universal Prosthetics, Inc.1983-09-26
SKIN STAPLING DEVICE SC2000 (K832709)Prosper, Inc.1983-09-26
SABOURAUD DEXTROSE AGAR (K832861)Troy Biologicals, Inc.1983-09-26
ARTERIAL BLOOD SAMPLING KIT (K832545)Dhd Medical Products Div. Diemolding Corp.1983-09-26
COLOR-EZE PRE-WASHED LAP SPONGES (K831913)Ormed Mfg., Inc.1983-09-26
QUANTUM II YEAST IDENT. SYSTEM (K832406)Abbott Laboratories1983-09-26
SXT BLOOD AGAR (K832860)Troy Biologicals, Inc.1983-09-26
STREP ID QUAD (K832863)Troy Biologicals, Inc.1983-09-26
OXYGEN CONNECTING TUBESET-RESPIRATORY (K832660)San Diego Plastics, Inc.1983-09-26
BACTIGEN S. PNEUMONIAE (K831887)Armkel, LLC1983-09-26
MIDDLEBROOK ADC ENRICHMENT (K832902)Gibco Laboratories Life Technologies, Inc.1983-09-26
ELEVATOR CUSHION (K832472)Inmed Corp.1983-09-20
ACCLAIM (K832648)Electro-Nucleonics Laboratories, Inc.1983-09-20
JASON CERVICAL ORTHOSIS (K832741)Orthomedics1983-09-20
SESAM TABLE (K832804)Electro-Med Health Industries, Inc.1983-09-20
WHEELCHAIR-VARIOUS MODELS (K832685)Health America1983-09-20
STEAM PAK MOIST HEAT (K832803)Electro-Med Health Industries, Inc.1983-09-20
SERA-TEK MYCOPLASMA ANTIBODY TEST (K832132)Miles Laboratories, Inc.1983-09-20
S & W SW52E W/POWER BACK LIFT (K832768)S & W Enterprises, Inc.1983-09-20
DUAL DIAL VENTURI STYLE MASK (K832725)Airlife, Inc.1983-09-20
EXTENSION CONTROL KNEE ORTHOSIS (K832742)Orthomedics1983-09-20
TRYPTIC SOY BROTH MEDIA (K832620)Carroll Biological Corp.1983-09-12
STERILE SUTURE REMOVAL SET (K832047)Ormed Mfg., Inc.1983-09-12
TRIGLYCERIDE REAGENT-TRINDER-GPO (K832460)Seppim, Inc.1983-09-12
SHERI-I-SLIP INTUBATING STYLET (K832773)Sheridan Catheter Corp.1983-09-12
ADJUSTABLE PHARYNGEAL AIRWAY/BERMAN III (K832471)Inmed Corp.1983-09-12
DISPOSABLE FLOOR INSTRUMENTS (K831911)Ormed Mfg., Inc.1983-09-12
INDOLE NITRATE MEDIUM (K832568)Acumedia Manufacturers, Inc.1983-09-12
XYLOSE LYSINE DEOXYCHOLATE (K832617)Carroll Biological Corp.1983-09-12
EASYTOUCH TRIGLYCERIDES REAGENT SET (K832426)Worthington Diagnostic Systems1983-09-12
SELENITE BROTH (K832614)Carroll Biological Corp.1983-09-12
BIO SURE STAIN (K832496)Helena Laboratories1983-09-12
INFUSION BROTH (K832569)Acumedia Manufacturers, Inc.1983-09-12
BASAL MED. EAGLE #B9888 W/L-GLUTAMINE (K832687)Sigma Chemical Co.1983-09-12
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