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

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RecordFirmDate
CUSTOM DRESSING TRAY-WET TO DRY/MASS. (K802385)American Medical Disposable, Inc.1980-11-12
UTAH ARTIFICAL ARM (K802642)Motion Control, Inc.1980-11-12
V FACTOR DISCS (K802501)Oxoid U.S.A., Inc.1980-11-12
CENTRAL VENOUS CATHETER DRESSING TRAY (K802384)American Medical Disposable, Inc.1980-11-12
SURGICAL HAMMERS (K802524)Midshore Welding Corp.1980-11-12
TELESONIC ARCON & SOUNDEX ASP 101 (K802597)Telesonic, Inc.1980-11-12
ORHTOPEDIC REAMER 87 HTD (K802676)Zimmer, Inc.1980-11-12
X & V FACTOR DISCS (K802502)Oxoid U.S.A., Inc.1980-11-12
SI-14 (K801908)Kmi Medical, Inc.1980-11-12
TRANSETTE SYSTEM/COLLECTION & TRANSP (K802563)Inolex Corp./Div of Biomedical1980-10-31
HEM-O-SCAN OXYGEN EQUIL. CURVE ANALYZER (K802379)American Instrument Co.1980-10-31
KODAK ORTHO L FILM (K802171)Eastman Kodak Company1980-10-31
ELECTROLY TE CHEMISTRY ANALYZER (K802398)Instrumentation Laboratory CO1980-10-31
COULTER DACOS SERUM CHEM. ANALYZER (K802320)Coulter Electronics, Inc.1980-10-31
OSTOMATE THIRD HAND (K802424)Smith'S Ostomy Products, Inc.1980-10-31
CENTRIFICHEM INORGANIC PHOSPHORUS (K802420)Union Carbide Corp.1980-10-31
WASH SOLUTION KIT, #88102 (K802264)Hi Chem, Inc.1980-10-31
ESTRIOL-SQUIBB RIA KIT (K802455)E. R. Squibb & Sons, Inc.1980-10-31
SURCAN KNEE HOLDING DEVICE (K802558)Bend Orthopedic & Fracture Clinic1980-10-31
SURGICAL KNIVES & PROBES (K802479)Eder Instrument Co, Inc.1980-10-31
BASIN PACK (K802538)Texas Medical Products, Inc.1980-10-31
FETAL BOVINE SERUM (K802418)S&S Biologicals1980-10-31
BETA LACTAMASE REAGENT DISK (K802566)Carr-Scarborough Microbiologicals, Inc.1980-10-31
HI VOLUME PUMPING CHAMBER (K802561)Acacia, Inc.1980-10-31
ARTHROSCOPIC FAT PAD RETRACTOR (K802599)The Anspach Effort, Inc.1980-10-31
BHI AGAR/BHI BROTH BIPHASIC BLOOD CLT.BT (K802415)Remel Co.1980-10-31
DRUG DETECTION SYSTEM (K802619)Syva Co.1980-10-31
MICRO-SUGICAL POWER INSTRUMENT SYSTEM (K802503)Spire Medical, Inc.1980-10-31
VIRAL TRANSPORT MED. (46-995-04) (K802303)Flow Laboratories, Inc.1980-10-31
LA-SPORO ANTIBODY SYSTEM (K802427)Immuno-Mycologics, Inc.1980-10-31
FLOWCLAMP CAT.#1011 & 1012 (K802009)Pollak (Intl.), Ltd.1980-10-31
LOW BACK POSTURE PILLOW (K802442)Body Therapeutics, Inc.1980-10-31
PHADEBACT PNEUMOCOCCUS TEST (K802337)Pharmacia, Inc.1980-10-31
COTTRELL 90/90 BACKTRAC (K802555)Lossing Orthopedic, Inc.1980-10-31
ANDROSTENEDIONE RADIOIMMUNOASSAY KIT (K801729)Diagnostics Biochem Canada, Inc.1980-10-31
MOTI PROTECTIVE X-RAY MASK (K802377)Moti Enterprises, Inc.1980-10-31
PLASTIC STRIP BANDAGES (K801837)Martin'S Maine Exchange1980-10-31
EMIT-STM ETHYL ALCOHOL URINE CONTROLS (K802618)Syva Co.1980-10-31
ANAEROBE BLOOD AGAR (K802397)Granite Diagnostics, Inc.1980-10-23
VIEW-LITE, MODEL-SL (K802217)Med-Western Electronics, Inc.1980-10-23
SP 120 SOPHISTICATE (K802251)Vickers America Medical Corp.1980-10-23
E-VAC BLOOD CULTURE SYSTEM (K802408)Pfizer Pharmaceuticals1980-10-23
URIC ACID/ALDH (K802371)Boehringer Mannheim Corp.1980-10-23
ARROW CATHETER CLAMP (K802367)Arrow Intl., Inc.1980-10-23
DEHYDROEPIANDROSTERONE SULFATE KIT RIA (K802195)Radioassay Systems Laboratories, Inc.1980-10-23
ARGLE LATEX PENROSE TUBING (K802286)Sherwood Medical Co.1980-10-23
TRIGLYCERIDES DETERMINATION (K802256)Coleman Laboratories Corp.1980-10-23
ASTRA PRINTER PAPER #88112-CHLORIDE SILV (K802392)Hi Chem, Inc.1980-10-23
NEBULIZER, MEDICINAL (K802430)Dhd Medical Products Div. Diemolding Corp.1980-10-23
THE IMMOBILIZER FOR OPEN & ARTHROSCOPIC (K802271)The Anspach Effort, Inc.1980-10-23
DAHLBERG HEARING AID MODEL AI (K802510)Dahlberg Electronics, Inc.1980-10-23
COS-UPHOFF INT'L DS-5 DRAINAGE SYSTEM (K802214)Cox-Uphuff Intl.1980-10-23
COTTON ROLLS (K802429)Worldwide Surgical Gauze1980-10-23
ARGYLE SILICONE THORACIC CATHETER (K802318)Sherwood Medical Co.1980-10-23
VIEW-LITE, MODEL-DL (K802216)Med-Western Electronics, Inc.1980-10-23
MO8 OXYGEN FLOWMETER (K802311)Timeter Instrument Corp.1980-10-23
TEMP STERNUM SAW (K801914)Temp Medical Products, Inc.1980-10-23
SALEM/RESCE INTUBATION GUIDE (K802416)Scientific Sales Intl., Inc.1980-10-23
SCOTT NEEDLE & SCOTT MICK IMPLANTER (K801983)Mick Radio-Nuclear Instruments, Inc.1980-10-23
VIEW-LITE, MODEL-S (K802215)Med-Western Electronics, Inc.1980-10-23
HEPA-SHURE -L (K802120)Nuclear Medical Laboratories, Inc.1980-10-20
KEMTROL SERUM CONTROL-NORMAL (K802108)Helena Laboratories1980-10-10
WIDEX HEARING AID #'S A18+T & A18+H (K802306)Hearing Aid Co.1980-10-10
OP-SITE SKIN CLOSURE SUTURE ADHESIVE (K801884)Acme United Corp.1980-10-10
WIDEX HEARING AID #'S A12+T & A12+H (K802307)Hearing Aid Co.1980-10-10
ARTERIAL BLOOD SAMPLING KIT (K802185)Current Technologies, Inc.1980-10-10
AMMONIUM MOLYBDATE INORGANIC PHOSPHORUS (K802159)Panmed, Inc.1980-10-10
AMERICAN MONITOR MAGNESIUM #'S 1036&4021 (K802091)American Monitor Corp.1980-10-10
DELTA TEST TRIGLYCERIDES (K802136)Bd Becton Dickinson Vacutainer Systems Preanalytic1980-10-10
TESTOSTERONE RADIOIMMUNOASSY KIT (K802135)Radioimmunoassay, Inc.1980-10-10
AO FLEXIBLE LARYNGOSCOPE, #LS-7 (K802331)American Optical Corp.1980-10-10
SPECIMEN SET (K802340)American Pharmaseal Div. Ahsc1980-10-10
PRESSURE MONITORING LINES (K802326)Stanco Medical, Inc.1980-10-10
ULTIMATE DIRECT & TOTAL BILIRUBIN CONTRO (K802068)Beckman Instruments, Inc.1980-10-10
AMPCO SKIN SCRUB TRAY (K802375)Associated Medical Products Co.1980-10-10
VIALON SURGEON'S GLOVES (K802027)Rivefain Corp.1980-10-10
CUSTOM LYMPHANGIOGRAM ACCES. PACK-STERI (K801964)American Pharmaseal Div. Ahsc1980-10-10
STERILE TONSIL SPONGES (K802060)Medspec Corp.1980-10-10
BED ROCKING DEVICE (K801517)Wesler1980-10-10
KEMTROL SERUM CONTROL ABNORMAL (K802109)Helena Laboratories1980-10-10
SERO STREP KIT (K801775)Sacks Farms Biological Products1980-10-10
CUSTOM UNIVERSAL CUTDOWN PREP TRAY (K801965)American Pharmaseal Div. Ahsc1980-10-10
URIC ACID DIAGNOSTIC REAGENT (K801898)Connecticut Diagnostics, Ltd.1980-10-10
DRESSING CHANGE SET CAT.#910-930 (K802017)Pollak (Intl.), Ltd.1980-10-10
E1 SERIES HEARING AID (K802324)Western Advanced Technology, Inc.1980-10-10
DOUCHE TRAY-DISPOS. VAGINAL TRAY W/POVID (K800954)The Healthcare Group Laboratories, Inc.1980-10-03
DOUCH TRAY-DISPOSABLE VAGINAL TRAY W/BEN (K800956)The Healthcare Group Laboratories, Inc.1980-10-03
BCM-302 COLLIMATING CONE & COMPENSATIN (K801949)B C Medical , Ltd.1980-10-03
HOT CYCLE, A CHEMICAL TYPE HOT PACK (K802252)Signal West1980-10-03
PEDIATRIC OXYGEN OR AEROSOL MASKS, (K802323)Airlife, Inc.1980-10-03
SHERWOOD NANO-MIST NEBULIZER W/MOUTHPIEC (K802281)Sherwood Medical Co.1980-10-03
HESSBURG-BFRRON TREPHINE (K801585)Precision Instruments, Inc.1980-10-03
OHIO THORACIC SUCTION REGULATOR (K802285)Ohio Medical Products1980-10-03
NU-VISION DISP. OPHTHALMIC DRESSING TRAY (K801822)Summit Optics, Inc.1980-09-30
CONICAL TIPPED CENTRIFUGE TUBE 15M (K802210)Scientific Specialties, Inc.1980-09-26
PROT-A-TRAC (K802072)Robert I. Branick, M.D.1980-09-26
DISPOSABLE NURSES CAP (K802186)Anago, Inc.1980-09-26
MODEL 203S CLINICAL CHEMISTRY ANALYZER (K801889)Gilford Instrument Laboratories, Inc.1980-09-26
DUPONT ACALACTIC ACID (LA) TEST (K802064)E.I. Dupont DE Nemours & Co., Inc.1980-09-26
SCANLAN STERNUM NEEDLE-SUTURE (K801976)Scanlan Intl., Inc.1980-09-26
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