Atlas FDA

1980

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

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RecordFirmDate
EXTERNAL SILASTIC BOOT FOR CARDIAC PULSE (K801806)Arco Medical Products Co.1980-09-09
CULSWAB CAT.#978 & 979 (K802023)Pollak (Intl.), Ltd.1980-09-09
IVAC 811Y ELEC. CLINICAL THERMOMETER (K801930)Y1980-09-09
LITTLE GIANT I & II HANDPIECE CONTROL (K801975)Silverman'S1980-09-09
DATA-ZYME UREA NITROGEN, COLORIMETRIC (K801727)Data Medical Associates, Inc.1980-09-09
AMS MALLEABLE OR JONAS SILICONE-SILVER (K792724)American Medical Systems, Inc.1980-09-09
ACE FISCHER EXTERNAL FIXATION DEVICE (K801594)Ace Orthopedic Manufacturing Co.1980-09-09
EYE PADS CAT.#581-599 (K801995)Pollak (Intl.), Ltd.1980-09-09
SOF-TOUCH NASAL CANNULA CAT.#304 & 305 (K802062)Hospitak, Inc.1980-09-09
ELECTROCARDIOGRAPH ELECTRODE (K801846)Phoenix Glove Co.1980-09-09
BRAIN HEART INFUSION MICROBIOLOGICAL (K801943)Radiation Technology, Inc.1980-09-09
BATTERY FOR #229-01 PULSE GENERATOR (K802040)Intermedics, Inc.1980-09-09
CONTINUOUS EPIDURAL ANESTHESIA TRAY/DRUG (K802065)Portex, Inc.1980-09-09
ASSURE LEVEL II PROD. #30172 (K801539)Warner-Lambert Co.1980-09-09
ORTHO AUTOMATED CELL COUNTER (K801545)Ortho Instruments1980-09-09
FE-3000 FETAL ELECTRODE, SPIRAL SYSTEM (K801984)Life Support, Inc.1980-09-09
HEP-TROL (K801932)Helena Laboratories1980-09-09
SUR-FIT SYSTEM STERILE O.R. SETS (K801703)E. R. Squibb & Sons, Inc.1980-09-09
PALPATION ENHANCER (K801811)Medical Horizons Co.1980-09-09
HI-LO TEMP GEN. PURPOSE TEMP. PROBE (K801924)National Catheter Co. Div. Mallinckrodt1980-09-09
EMBOSSED DISP. POLY. GLOVES #5101-03 (K801997)Pollak (Intl.), Ltd.1980-09-09
STERILE EXAMINATION GLOVE #5121-5126 (K801998)Pollak (Intl.), Ltd.1980-09-09
SIGMA PROCEDURE #880 FIBRINOGIN/PLASMA (K801926)Sigma Chemical Co.1980-09-09
PREP SET CAT.#908 (K802020)Pollak (Intl.), Ltd.1980-09-09
VOCON MODEL VC526 (K801314)Teknar, Inc.1980-09-09
CUFFED TRACHEA TUBE FOR USE W/PERTRACH (K801379)Frederic J. Toye, M.D.1980-09-09
FIELD-LEE BRAIN BIOPSY NEEDLE (K801760)American V. Mueller1980-09-09
HANCOCK * OBTURATORS (K801885)Hancock Laboratories, Inc.1980-09-09
TEST PANEL FOR PRESUMP. ID/BACT. ORG (K801547)Micro-Media Systems, Inc.1980-09-09
PA-1 LOW PRESSURE ALARM (K802112)Puritan Bennett Corp.1980-09-06
SALMONELLA FLAGELLAR A ANTIGEN & B (K801693)Bd Becton Dickinson Vacutainer Systems Preanalytic1980-08-27
ASNIS GUIDED SCREW SYSTEMS (K801969)Howmedica Corp.1980-08-27
BIOMEGA #423-B BLOOD PRESSURE & PULSE CK (K801923)Bio Mega Diagnostic, Inc.1980-08-27
TOTAL PARENTERAL NUTRITION SET BAG (K801652)Cutter Laboratories, Inc.1980-08-27
GAS-CHROMATOGRAPHIC PACKING (K801833)Supelco, Inc.1980-08-27
SUR-FIT SYSTEM PRE-OPERATION SET (K801702)E. R. Squibb & Sons, Inc.1980-08-27
VIVALITH 5, - MDL-201A & TDL-201A (K801763)Pacesetter Systems1980-08-27
MICRO-PROCESSOR UNIT #A3600AC (K801762)General Electric Co.1980-08-27
PRIMARY SOLUTION ADMIN. SET-#86-01-0 260 (K801871)Y1980-08-27
PAD, EXAMINING TABLE (K801936)Volunteer Blind Industries, Inc.1980-08-27
MODEL 86-01-1 260 SOLUTION ADMIN. SET (K801872)Y1980-08-27
GAMBRO LUNDIA PLATE HIGH FLUX HEMODIAL- (K801479)Gambro, Inc.1980-08-27
CAL-COUNT (K801868)Bayshore Systems Corp.1980-08-27
HOWMEDICA BITE BLOCK (K801911)Howmedica Corp.1980-08-27
MMI/GAELTEC CATHETER TIP PRESS. TRANSDU (K801757)Medical Measurements, Inc.1980-08-27
TESTOSTERONE KIT (K801666)Immuchem Corp.1980-08-27
FIAX TEST KIT FOR THEOPHYLLINE QUANT. (K801642)Intl. Diagnostic Technology1980-08-27
FLUORO-MARK RADIOPAQUE ANATOMICAL MKR. (K801637)C.R. Bard, Inc.1980-08-27
MICROBIOLOGY CULTURE MEDIA, C.L.E.D. (K801817)Radiation Technology, Inc.1980-08-27
TSH RIASSAY (K801691)Ria Diagnostics1980-08-27
DRUALIFT 500 (K801933)Independent Transfer Equipment Co.1980-08-27
SYRINGE INFUSION PUMP #2716 (K801904)Harvard Apparatus, Inc.1980-08-27
BURRON MICROCATH INTRA. CATH. PLACEMENTT (K801941)Burron Medical Products, Inc.1980-08-27
IVAC 260 SERIES VOLUME TRIC INFUSION CON (K801861)Y1980-08-27
GLUCOSE (TRINDER) REAGENT (K801600)Gilford Diagnostics1980-08-27
PAD, HOSPITAL STRETCHER (K801935)Volunteer Blind Industries, Inc.1980-08-27
FONIX TYPE 5100 HEARING AID ANALYZER (K801905)Frye Electronics, Inc.1980-08-27
MODEL 9200 VIS-U-SCAN (K801832)Del Mar Avionics1980-08-27
GAMBRO LUNDIA MAJOR HIGH FLUX HEMODIALYZ (K801480)Gambro, Inc.1980-08-27
SSC8 SORENSON SUBCLAVIAN CATHETER (K801478)Sorensen Research1980-08-27
DESERET I.V. FILTER (K801602)Hospital Products Co.1980-08-27
MODEL 86-21-0 260 SECONDARY MEDICATION (K801873)Y1980-08-27
RTM SYSTEM (REMOTE TEMPERATURE MONITOR) (K801423)Remote Technologies, Inc.1980-08-27
MARTIN TRACH-SECURE (K801931)Acucare Medical, Inc.1980-08-27
TALEISNIK TOTAL WRIST PROSTHESIS (K800602)Dow Corning Wright1980-08-27
RESPONDER II (K801894)Clinical Microsystems Intl.1980-08-27
CYBER 120 HEMODIALYZER (K801377)Cyberex Corp.1980-08-27
MEDI-TRACE DISP. STOPCOCKS/PHYSIO. PRESS (K801828)Graphic Controls Corp.1980-08-27
PERMITE DENTAL AMALGAM ALLOY (K801639)Southern Dental Industries, Inc.1980-08-27
THE SIMPLICITY PUMP #2100 INFUSION PUMP (K801546)Critikon Company, LLC1980-08-27
DIOPTRON III AUTOREFRACTOR (K801906)Coherent Medical Division1980-08-27
MEDI-TRACE DISP. FLUSHING DEV./MONITOR (K801829)Graphic Controls Corp.1980-08-27
MODEL 86-21-1 260 APPROX. 60 DROPS/VENTD (K801874)Y1980-08-27
NEUROGAR IV-EXTERNAL NEURO-MUSCLE STIM. (K801577)Inter Med Industries, Inc.1980-08-27
FLOTATION PAD FOR OPERATING TABLE (K801694)Action Products, Inc.1980-08-27
MODEL 9300 ELECTROCARDIOVALIDATOR (K801830)Del Mar Avionics1980-08-27
AMPCO DRESSING CHANGE TRAYS (K801333)Associated Medical Products Co.1980-08-22
LAB-TEK FTA-ABS KIT (K801928)Miles Laboratories, Inc.1980-08-20
BURR, DENTAL (K801886)Aesculap Instruments Corp.1980-08-20
SERALYZER GLUCOSE CALIBRATORS(LOW&HIGH) (K801665)Miles Laboratories, Inc.1980-08-20
CORNING 184 BLOOD GAS TONOMETER (K801599)Corning Medical & Scientific1980-08-20
BAND-AID BRAND TRICOT MESH BANDAGES (K801823)Johnson & Johnson Professionals, Inc.1980-08-20
ELECTRO-ACUSCOPE-70 (K801459)Nebrensky Corp.1980-08-20
SOLAR PACIFIC UVA SUNLAMP DEVICE (K801520)Solar Pacific1980-08-20
ENZYME-ASE I TUBES (K801915)Microchemical Specialities, Co.1980-08-20
MARK V DUPLEX ULTRASONIC SCANNING SYSTEM (K801598)Advanced Technology Laboratories, Inc.1980-08-20
PHOTOMETER LP 3 (K801563)Dr. Bruno Lange GmbH1980-08-20
BK-1499 KAY-KPLINT HAND CONE/BK-1500 (K801707)Fred Sammons, Inc.1980-08-20
PHOTOMETER LP 6 (K801562)Dr. Bruno Lange GmbH1980-08-20
HANDPIECE, DENTAL (K801888)Aesculap Instruments Corp.1980-08-20
SUTURE REMOVAL PAK (K801746)Devco Medical Industries, Inc.1980-08-20
SONACOLOR 6100 (K801647)Carolina Medical Electronics1980-08-20
ORNITH-ASE TUBES (K801916)Microchemical Specialities, Co.1980-08-20
SHARPLAN 723 CO2 LASER SURGICAL SYSTEM (K801624)Laser Industries , Ltd.1980-08-20
MMI/GAELTEC CATHETER TIP TRANSDUC (K801756)Medical Measurements, Inc.1980-08-20
BAND-AID BRAND FLEXIBLE FABRIC BANDAGE (K801824)Johnson & Johnson Professionals, Inc.1980-08-20
WALL MOUNTED LASER POSITIONING DEVICE (K801541)Advantage Medical Systems, Inc.1980-08-20
FERRIZYME FERRITIN ENZYME IMMUNOASSAY (K801676)Abbott Laboratories1980-08-20
JACKSON-PRATT LARGE VOL. CLOSED WOUND (K801766)American Heyer Schulte1980-08-20
CORDIS FLOW DIRECTED BALLOON CATHETER (K801865)Cordis Corp.1980-08-20
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Every clearance here is in the API, with alerts when new ones post.