Atlas FDA

1980

2,857 FDA 510(k) clearances · Clearance year

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RecordFirmDate
SCHURING OSSICLE CUP & COLUMELLA PROSTH. (K802431)Richard'S Medical Equip., Inc.1980-11-12
TELESONIC ARCON & SOUNDEX ASP 101 (K802597)Telesonic, Inc.1980-11-12
DISPOSABLE SURGICAL DRAPE (K802537)Texas Medical Products, Inc.1980-11-12
AMP PORTABLE PATIENT PRESSURE MONITOR (K802600)American Medical Products, Inc.1980-11-12
CBC PAP TEST KIT (K802153)Calbiochem-Behring Corp.1980-11-12
DENTAL MOUTH PROP. (K802696)Trident Dental, Inc.1980-11-12
ORHTOPEDIC REAMER 87 HTD (K802676)Zimmer, Inc.1980-11-12
HAND PERCUSSOR CUP #65210 (K802646)B & F Medical Products, 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
MODEL SD-1 DISINTEGRATOR (K802322)Northgate Research, Inc.1980-11-10
NEMECTRODYN 5 (K802805)Nemectron Medical, Inc.1980-11-05
TRANSETTE SYSTEM/COLLECTION & TRANSP (K802563)Inolex Corp./Div of Biomedical1980-10-31
EMIT-STM ETHYL ALCOHOL URINE CALIBRATOR (K802620)Syva Co.1980-10-31
HEM-O-SCAN OXYGEN EQUIL. CURVE ANALYZER (K802379)American Instrument Co.1980-10-31
KEOFEED (R) EASY-FILL ENTERIC FEED BAG (K802482)Health Development Corp.1980-10-31
FEEDING TUBES IN SILICONE 5,6,8&10 SIZES (K802585)The Healthcare Group Laboratories, Inc.1980-10-31
GESTATE SLIDE EIKEN KIT AGG. METHOD HUM (K802450)Syn-Kit, Inc.1980-10-31
KODAK ORTHO L FILM (K802171)Eastman Kodak Company1980-10-31
POLYFLEX IMPLANTABLE PACING LEAD (K802293)Intermedics, Inc.1980-10-31
ELECTROLY TE CHEMISTRY ANALYZER (K802398)Instrumentation Laboratory CO1980-10-31
WISCONSIN HEART RATE MONITOR (K802182)Lunar Radiation Corp.1980-10-31
EMIT-STM ETHYL ALCOHOL ASSAY (K802621)Syva Co.1980-10-31
FERTILITY AWARENESS METHOD KIT (K801791)Telesis Corp.1980-10-31
EMIT-STM OPIATE ASSAY (K802615)Syva Co.1980-10-31
MINIVISOR TERMINAL (K802263)Organon Teknika Corp.1980-10-31
EMIT-STM BARBITURATE ASSAY (K802617)Syva Co.1980-10-31
DISP. FENESTRATED SURG. DRAPE SHEETS (K802359)American Convertors Div., American Pharmaseal1980-10-31
COULTER DACOS SERUM CHEM. ANALYZER (K802320)Coulter Electronics, Inc.1980-10-31
TSH RADIOIMMUNOASSAY KIT (K802467)American Diagnostic Corp.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
OREAI-Q-TU TEST (K802464)Organon, Inc.1980-10-31
PACEPATH MODEL 810 (K801416)Pacesetter Systems1980-10-31
SPATULA, CERVICAL CYTOLOGICAL CYTOLOGY (K802139)Dyn-A-Med Products1980-10-31
HOLLO FIBER DIALYZER (K801559)Renal Devices, Inc.1980-10-31
GOAT ANTI-HUMAN IGM (K802177)Protos Laboratories1980-10-31
INFUSSION ALARM SYSTEM I.A.S. CAT.#1118 (K802011)Pollak (Intl.), Ltd.1980-10-31
COMFORT CUSHION DRY BURN PADS, STERILE (K802317)American Convertors Div., American Pharmaseal1980-10-31
EMIT-STM BENZODIAZEPINE ASSAY (K802616)Syva Co.1980-10-31
ICA1 IONIZED CALCIUM ANALYZER (K801848)The London Co.1980-10-31
ESTRIOL-SQUIBB RIA KIT (K802455)E. R. Squibb & Sons, Inc.1980-10-31
LEG BAG EXTENSION TUBE (K802606)Associated Medical Products Co.1980-10-31
CHEEK TOOL SET (K802138)Codman & Shurtleff, 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
ENDAB DIGITOXIN ENZYME IMMUNOASSAY KIT (K802461)Immunotech Corp.1980-10-31
RANAWAT ESF TOTAL CONDYLAR KNEE (K802446)Howmedica Corp.1980-10-31
BASIN PACK (K802538)Texas Medical Products, Inc.1980-10-31
T3 UPTAKE TEST SYSTEM (K802468)American Diagnostic Corp.1980-10-31
DEPALMA ELBOW (K801574)Zimmer, 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
GAMBRO HEMOFREEZE-BAG (K801082)Gambro, Inc.1980-10-31
STERI-SLEEVE (K802629)Cordis Corp.1980-10-31
MICROTHIN-DI BIPOLAR PULSE GENERATOR (K802409)Cardiac Pacemakers, Inc.1980-10-31
ARIA II 125 I CORTISOL (K802380)Bd Becton Dickinson Vacutainer Systems Preanalytic1980-10-31
MICRO-SURGICAL POWER INSTRUMENT SYSTEM (K802463)Spire Medical, Inc.1980-10-31
3MP-7 SCANNER RESPIRATORY MONITOR (K802565)Bird Products Corp.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
CYBREX LIDOCAINE (K802131)Abbott Laboratories1980-10-31
BHI AGAR/BHI BROTH BIPHASIC BLOOD CLT.BT (K802415)Remel Co.1980-10-31
CENTRIFICHEM ALBUMIN (K802436)Union Carbide Corp.1980-10-31
DRUG DETECTION SYSTEM (K802619)Syva Co.1980-10-31
MICRO-SUGICAL POWER INSTRUMENT SYSTEM (K802503)Spire Medical, Inc.1980-10-31
MISTY NEBULIZER (K802477)Airlife, Inc.1980-10-31
GOAT ANTI-HUMAN COMPLEMENT C4 (K802196)Protos Laboratories1980-10-31
VIRAL TRANSPORT MED. (46-995-04) (K802303)Flow Laboratories, Inc.1980-10-31
BARD MALE EXTERNAL CATHETER (K802433)C.R. Bard, Inc.1980-10-31
PACEMAKER LEAD ADAPTOR MODEL 431 (K802407)Pacesetter Systems1980-10-31
CELLTRIFUGE II (K801233)Travenol Laboratories, S.A.1980-10-31
FOLEY CATHETER (K802516)Abco Dealers, Inc.1980-10-31
LA-SPORO ANTIBODY SYSTEM (K802427)Immuno-Mycologics, Inc.1980-10-31
CHEEK EPIDURAL SCREW (K802137)Codman & Shurtleff, Inc.1980-10-31
PLASMAPOOLER (K801219)North American Biologicals, 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
MICROTHIN-PI BIPOLAR PULSE GENERATOR (K802410)Cardiac Pacemakers, Inc.1980-10-31
COMPUPACE, 524-01 PACER SYSTEM COMPUTER (K801055)Intermedics, Inc.1980-10-31
GOAT ANTI-HUMAN IGG GAMMA CHAIN SPECIFIC (K802257)Protos Laboratories1980-10-31
PHADEBACT PNEUMOCOCCUS TEST (K802337)Pharmacia, Inc.1980-10-31
COTTRELL 90/90 BACKTRAC (K802555)Lossing Orthopedic, Inc.1980-10-31
UTERINE VACUM ASPIRATING CURRETTE (K802360)American Hospital Supply Corp.1980-10-31
T4-SQUIBB RIA KIT (K802456)E. R. Squibb & Sons, Inc.1980-10-31
ANDROSTENEDIONE RADIOIMMUNOASSAY KIT (K801729)Diagnostics Biochem Canada, Inc.1980-10-31
THERMOCOMP (K801553)Hospital Financial Corp.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
GCS-79 (K801921)Gilmore Liquid Air Co.1980-10-31
FLUORESCENT SUN LAMP FIXTURE (K802291)Strato-Ray Co.1980-10-31
7FRENCH FLOW DIRECTED TRIPLE LUMEN CATH (K802481)Waters Assoc., Inc.1980-10-31
EMIT-STM ETHYL ALCOHOL URINE CONTROLS (K802618)Syva Co.1980-10-31
L-15T ENDOCARDIAL PACING ELECTRODE (K802689)Coratomic, Inc.1980-10-28
OCCUPAK CAT.#200-0538 (K802691)Occumedics, Inc.1980-10-27
EMPTY TRANSFER BAGS (K802671)Delmed, Inc.1980-10-27
ANAEROBE BLOOD AGAR (K802397)Granite Diagnostics, Inc.1980-10-23
MULTICHANNEL TELEMETRY SYSTEM (K801944)Burdick Corp.1980-10-23
MINOCYCLINE 30MCG. SENSI DISC (K802194)Bd Becton Dickinson Vacutainer Systems Preanalytic1980-10-23
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Every clearance here is in the API, with alerts when new ones post.