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

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RecordFirmDate
BEHIND-THE-EAR HEARING AIDS T-87 & (K833775)Bernafon, Inc.1983-12-08
COAGULASE PLASMA, HORSE & RABBIT EDTA (K833858)Otisville Biotech, Inc.1983-12-08
BRONCHITRAC DF DUAL RESP/CATHETER (K833633)Ackrad Laboratories1983-12-08
FLAME PHOTOMETER T281-T282-T283 (K832886)Texas Intl. Laboratories, Inc.1983-12-08
P-S MEDICAL BERLIN VISADUCT KIT (K832677)Pudenz-Schulte Medical Research Corp.1983-12-08
OTICON, E26P (K833803)Oticon Corp.1983-12-08
IN THE EAR HEARING AID OMNI 100 (K833333)Omni Hearing Systems1983-12-08
IMPACT 400 #1447X2 (K833067)Gilford1983-12-08
WISDOM AIRWAY (K833482)Wisdom Corp.1983-12-05
MACLEAN-FOGG, TISSUE CASSETTES (K833857)Polymer Technology Corp.1983-12-02
PREPARED TRYPTIC SOY AGAR 100 MM PLATE (K833507)Lavco Laboratory, Inc.1983-12-01
KNEE WALKER (K833870)Maddak, Inc.1983-11-29
OHIO GMS ABSORBER (K833452)Airco/Ohio Medical Products1983-11-29
CHILD'S WALKER (K833869)Kaye Products, Inc.1983-11-29
MASSATOR-PEDIO (K833840)Trileen, Inc.1983-11-29
SYSTENET (K832544)American Intl. Medical Supply Co.1983-11-29
RX SEG ECONOPLUS (K833286)Genesis Industries, Inc.1983-11-28
SURGICAL INSTRUMENT (K833541)Hirata Sangyo Co. USA, Inc.1983-11-28
LINEAR VIBRATION A MCSHIRLEY PRODUCT (K833370)Mcshirley Products, Inc.1983-11-28
RX 41 PENTRON 41 (K833284)Genesis Industries, Inc.1983-11-28
CHEMONUCLEOLYSIS TABLE (K833509)Stryker Corp.1983-11-28
RX D PENTRON (K833281)Genesis Industries, Inc.1983-11-28
MICRO-SAMPLE OSMOMETER 3M0 (K832783)Advanced Instruments, Inc.1983-11-28
MULTIPLE (K831204)Derma-Lock Medical Corp.1983-11-28
RX ORY PENTRON C & B (K833283)Genesis Industries, Inc.1983-11-28
FPC FECAL PARASITE CONCENTRATOR (K833469)Evergreen Scientific, Inc.1983-11-28
JH PEPTONE AGAR (K833291)Acumedia Manufacturers, Inc.1983-11-28
PRESERV PVA FIXATIVE -MALIN PACK (K833660)Preventive Diagnostics Corp.1983-11-28
NATURELLE-LITE (K833279)Genesis Industries, Inc.1983-11-28
SURGICAL INSTRUMENT (K833542)Hirata Sangyo Co. USA, Inc.1983-11-28
AQUEOUS BLOOD GAS CONTROL (K833146)Bionostics, Inc.1983-11-28
ACTIVE LIFE (K833625)Convatec, A Division of E.R. Squibb & Sons1983-11-28
PDI SURGICAL SCRUB/BRUSH T150-70 (K833549)Nice-Pak Products, Inc.1983-11-28
EGERTON TURNING & TILTING NET SUSPEN BED (K832845)Kinetic Concepts, Inc.1983-11-28
RX NYSP PENTRON 60 (K833282)Genesis Industries, Inc.1983-11-28
GENTLE FLOW BREAST PUMP (K833835)Eklund & Co.1983-11-28
SHUTT UNIVERSAL STRESS POST (K833624)Concept, Inc.1983-11-28
NOVA 10 SODIUM/POTASSIUM/TOTAL CALCIU (K833153)Nova Biomedical Corp.1983-11-25
QUICK STAIN WRIGHT'S GIEMSA W/BUFF (K833677)J.S. Medical Assoc.1983-11-25
HEMATOLOGY WRIGHT'S-GIEMSA SATIN PACK (K833665)J.S. Medical Assoc.1983-11-25
HEMATOLOGY WRIGHT'S STAIN PACK (K833678)J.S. Medical Assoc.1983-11-25
ELASTOPLAST (K831438)Beiersdorf, Inc.1983-11-25
DUPONT LINEARIZATION MODULE (K832746)E.I. Dupont DE Nemours & Co., Inc.1983-11-25
SERUM CHOLINESTERASE REAGENT SET (K833062)Sterling Biochemical, Inc.1983-11-25
REAGENT SET TRIGLYCERIDES GPO (K833082)Boehringer Mannheim Corp.1983-11-25
TOOTH SLOOTH (K833338)Joel Lander D.D.S.1983-11-25
GOLD FILM MERCURY ANALYZER #511 (K832933)Jerome Instrument Corp.1983-11-25
INNOVATIVE HEARING CORP. #IHC 1000 (K832633)Innovative Hearing Corp.1983-11-21
HEARING AID, UNITRON UT1 (K833614)Unitron Industries, Inc.1983-11-21
ALPHA-I (K832642)Johnson Flexgroup1983-11-21
CLEX (K833463)Dextran Products, Ltd.1983-11-21
DIACROM *PLG (K832591)Wellcome Diagnostics1983-11-21
PERSONAL AMPLIFIER (K832168)Electone, Inc.1983-11-21
CEMAX-1000 (K833525)Contour Medical Systems, Inc.1983-11-21
HEARING AID UNITRON UI3 (K833615)Unitron Industries, Inc.1983-11-21
REPORTING INTEGRATOR 3392A (K833113)Hewlett-Packard Co.1983-11-21
TAGO DIFFU-GEN-APOLIPOPROTEIN B-100 (K833129)Tago, Inc.1983-11-21
NUK BREAST SHIELD (K833450)Reliance Products Corp.1983-11-21
C.B. RADIOLOGY DESIGN GONADSHIELD (K833523)Radiology Design1983-11-21
PANASONIC WH-50 HEARING AID (K833510)Panasonic Co. Div. Matsu Elec. Corp. America1983-11-14
SOFFBAN ORTHOPEDIC PADDING (K832992)Smith & Nephew, Inc.1983-11-14
BOUINS SOLUTION (K833515)Sigma Chemical Co.1983-11-14
VASCULAR LABORATORY TREADMILL VT1 (K833588)Medasonics, Inc.1983-11-14
LARYNGOSCOPE BLADES/HANDLES & LAMPS (K833055)Medovations, Inc.1983-11-14
BEHIND THE EAR ASP-BB (K833334)Omni Hearing Systems1983-11-14
BACTERUERIA SCREENING PROCEDURE (K832975)Turner Designs, Inc.1983-11-14
GONOCHEK-II (K833180)E-Y Laboratories, Inc.1983-11-14
TEL-STAR NUWAY & GENERIC E ASP-BP (K833451)Omni Hearing Systems1983-11-14
RIONET HEARING AID HB-345 (K833134)Rion Acoustic Instruments, Inc.1983-11-14
FITNESS (K833249)Fitness Equipment Co., Inc.1983-11-07
BRUCELLA AGAR MODIFIED (K833299)Acumedia Manufacturers, Inc.1983-11-07
PHOENIX 60/60 PROCESSOR MODULE (K831134)Phoenix Corp.1983-11-07
PREPARED MACCONKEY AGAR (K833508)Lavco Laboratory, Inc.1983-11-07
SPIRIT CHEMISTRY SYSTEM (K833116)Baker Instructions Corp.1983-11-07
STIFNICK IMMOBILIZING COLLAR (K832990)Laerdal California, Inc.1983-11-07
SABOURAUD BHI AGAR (K833300)Acumedia Manufacturers, Inc.1983-11-07
BACK MASSAGER B-400 ADJUSTABLE (K832913)Pollenex Associated Mills, Inc.1983-11-07
MEDIUM 199 W/EARLE'S SALTS W/L-GLUTAM (K833389)Sigma Chemical Co.1983-11-03
BIO-REX 70 RESIN 100-200 MESH PH6.2 (K833319)Biosan Laboratories, Inc.1983-11-03
MINI OX III OXYGEN MONITOR (K833326)Catalyst Research Corp.1983-11-03
ISOTONIC BLOOD CELL DILUENT J & S (K833443)Jasins & Sayles Associates, Inc.1983-11-03
TUBE-TITLE (K833361)Sontek Industries, Inc.1983-11-03
TYRODE'S SALT SOLUTION W/SODIUM BICAR (K833390)Sigma Chemical Co.1983-11-03
VEIGERT'S IRON HEMATOXYLIN STAIN-HT10-79 (K833424)Sigma Chemical Co.1983-11-03
BITE-BLOCK (K833374)Sontek Industries, Inc.1983-11-03
BODIA TRACH-SAF DOUBLE SWIVEL (K833372)Sontek Industries, Inc.1983-11-03
LACTALBUMIN HYDROLYSATE MED. W/HANKS (K833391)Sigma Chemical Co.1983-11-03
ISCOE'S MOD. DULBECCO'S MED. W/GLUTAM (K833393)Sigma Chemical Co.1983-11-03
TECHNICON RA-1000 SYSTEM (K833023)Technicon Instruments Corp.1983-11-03
MEDIUM 199 W/HANK'S SALT W/L-GLUTAMINE (K833394)Sigma Chemical Co.1983-11-03
WI-38 CELLS (K833359)Biocon, Inc.1983-11-03
SILICONE SOFT-PAK EPISTAXIS CATHETER (K832476)Axiom Medical, Inc.1983-11-03
ARGYLE NASAL CANNULA (K833127)Sherwood Medical Co.1983-11-03
LYSING & HEMOGLOBIN S-REAGENT J & S (K833444)Jasins & Sayles Associates, Inc.1983-11-03
VOLUME VENTILATOR CIRCUIT-NEBULIZER (K833196)Airlife, Inc.1983-11-03
HEP-2 CELLS (K833360)Biocon, Inc.1983-11-03
SERUM IRON & TIBC#65084 & 65085 (K833017)Emd Chemicals, Inc.1983-11-03
ORTHOPEDIC STOCKINETTE (K833437)Northern Medical Surgical, Inc.1983-11-03
WAYMOUTH MB 752/1 MED. W/L-GLUTAMINE (K833392)Sigma Chemical Co.1983-11-03
BODIA BRONCH-SAF DOUBLE SWIVEL (K833373)Sontek Industries, Inc.1983-11-03
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