Atlas FDA

1979

2,434 FDA 510(k) clearances · Clearance year

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RecordFirmDate
DAC-CEL T4 (K791231)Burroughs Wellcome Co.1979-09-04
IMPLANTABLE PULSE GENERATOR PACEMAKER (K791417)Intermedics, Inc.1979-09-04
KODAK ORTHO M FILM (K791360)Eastman Kodak Company1979-09-04
TSH RIA KIT (K791217)Antibodies, Inc.1979-09-04
ANTISERUM, HUMAN, IGG H & L CHAIN (K790702)Kent Laboratories, Inc.1979-09-04
CEREBRAL FUNCTION MONITOR 870 (K791580)Applied Medical Research1979-09-04
FETASONDE UTERINE WORK MONITOR (K791036)Roche Medical Electronics, Inc.1979-09-04
VITREOUS SUCTION/CUTTER (K791000)Concept, Inc.1979-09-04
RP-610 PARALLEL PLATE DIALYZER (K790827)Hospal Medical Corp.1979-09-04
XLD AGAR (XYLASE LYSINE DESOXY AGAR) (K791477)Isle Media and Sterile Products, Inc.1979-09-04
SURELOC EXTERNAL CONNECTOR (K791532)Polamedco, Inc.1979-09-04
FETASONDE FETAL ACTIVITY MONITOR (K791035)Roche Medical Electronics, Inc.1979-09-04
FIBRO-TEC TEST KIT (K791358)Calbiochem-Behring Corp.1979-09-04
FETASONDE UTERINE ACTIVITY MONITOR (K791038)Roche Medical Electronics, Inc.1979-09-04
BILI-DOSIMETER (K791114)Olympic Medical Corp.1979-09-04
JELONET PARAFFIN GAUZE DRESSINGS (K791573)Acme United Corp.1979-09-04
HEKTOEN ENTERIC AGAR (K791475)Isle Media and Sterile Products, Inc.1979-09-04
TONGUE SCRAPER (K790895)Peter G. Finamore, Sr.1979-09-04
GLUCOSE GOD-PAP TRINDER METHOD TEST KIT (K791066)Fermco Biochemics, Inc.1979-09-04
ENDO AGAR (K791479)Isle Media and Sterile Products, Inc.1979-09-04
FETASONDE LABOR STATUS DISPLAY (K791037)Roche Medical Electronics, Inc.1979-09-04
AXIOM GASTRO SUMP DRAIN (K791509)Axiom Medical, Inc.1979-09-04
ELECTROCARDIOGRAPH MODEL ECG-5403 (K791540)Nihon Kohden America, Inc.1979-09-04
SIMMONS CITRATE AGAR (K791474)Isle Media and Sterile Products, Inc.1979-09-04
DENTAL XERORADIOGRAPHY (K791014)Xerox Medical Systems1979-09-04
DAC-CEL T3 (K791232)Burroughs Wellcome Co.1979-09-04
GOAT ANTI-HUMAN ALPHA-1-ANTITRYPSIN (K791605)Protos Laboratories1979-09-04
ANTISERUM TO HUMAN HEMOPEXIN (K790713)Kent Laboratories, Inc.1979-09-04
AXIOM FILTERED CONNECTOR (K791508)Axiom Medical, Inc.1979-09-04
MODELS UL-804 AND BL-801 UNIPOLAR LEADS (K791552)Pacesetter Systems1979-09-04
MODEL 114 TREONIC H150 HAEMOHEATER (K790936)Vickers America Medical Corp.1979-09-04
ANTISERA TO HUMAN FRAGMENT (K790711)Kent Laboratories, Inc.1979-09-04
GELSKIN (K791162)Spenco Medical Corp.1979-09-04
FETASONDE FETAL HEART RATE VARIABILITY (K791039)Roche Medical Electronics, Inc.1979-09-04
ELECTROSURGICAL CUT AND COAGU ACCESSORY (K791362)Intermedics, Inc.1979-09-04
.E.C MEDIUM (ESCHERICHIA COLI MEDIUM) (K791476)Isle Media and Sterile Products, Inc.1979-09-04
BIOLITE CARBON COATED DENTAL IMPLANT (K791491)Carbomedics, Inc.1979-09-04
PYROLITE CARBON ENDOSSEOUS DENTAL IMPL (K791237)Carbomedics, Inc.1979-08-28
STAT (K790893)Varian Assoc., Inc.1979-08-28
MINISCOPE MS-2B ELECTROCARDIOSCOPE (K791421)Renesco International, Inc.1979-08-28
TWO-PIECE IPPB MANIFOLD FOR SUPPLY LINE (K791443)Airlife, Inc.1979-08-28
COMPUTERIZED ELECTRO-OCULOGRAPH (K790637)Potomac Medical System1979-08-28
APOLLO HEART RATE INDICATOR (K791207)Key Tronic Corp.1979-08-28
DYNAMIC HIP SCREW (K791619)Synthes (Usa)1979-08-28
DCG-VII ELECTROCARDIOSCANNER (K791424)Del Mar Avionics1979-08-28
MICROMEDIC APS2 (K791324)Micromedic Systems1979-08-28
TWO-PIECE IPPB MANIFOLD MACHINES (K791445)Airlife, Inc.1979-08-28
MODEL 78520A ARRHYTHMIA MONITORING SYS (K791487)Hewlett-Packard Co.1979-08-28
BARRIER* X-RAY CASSETTE DRAPE (K791440)Surgikos, Inc.1979-08-28
ADAPTER-Y TYPE/CORONARY PERFUSION (K791498)Dlp, Inc.1979-08-28
AIRSTRIP THEATRE WARD DRESSING (K791369)Acme United Corp.1979-08-28
FABRIC 450* TOWEL DRAPE (K791486)Surgikos, Inc.1979-08-28
ABCOR CARIES DETECTOR MONITOR (K791133)Abcor, Inc.1979-08-28
PARAPODIUM (K791565)Physico-Medical Systems Corp.1979-08-28
MINIPRIME HYPOTHERMIC HEAT EXCHANGER (K791430)Travenol Laboratories, S.A.1979-08-28
BARRIER* C-ARM DRAPE (K791438)Surgikos, Inc.1979-08-28
BARRIER* OVERHEAD TABLE DRAPE (K791439)Surgikos, Inc.1979-08-28
MANIFOLD/NEBULIZER BREATHING PRODUCTS (K791469)Hospitak, Inc.1979-08-28
DISPOSABLE PERFORATORS, JACOBS, HUDSON (K791101)Codman & Shurtleff, Inc.1979-08-28
MINIGRAPH MG-I ELECTROCARDIOGRAPH (K791420)Renesco International, Inc.1979-08-28
PERITONEAL PAC (K791426)Intermed, Inc.1979-08-28
BIOASSAY SYSTEM, MS-2 SERUM (K782049)Abbott Laboratories1979-08-28
UNIVERSAL TWO-PIECE MACHINES (K791444)Airlife, Inc.1979-08-28
BARRIER *450* TAPE STRIP (K791500)Surgikos, Inc.1979-08-28
RAY-BAN SUN GLASSES (K791499)Bausch & Lomb, Inc.1979-08-28
API 20E REAGENT QC (K791222)Analytical Products, Inc.1979-08-22
MODEL MHS-20, ATOMIC ABSORPTION ACCESS (K791074)The Perkin-Elmer Corp.1979-08-22
MODEL 810 VERI/TGS (K791187)Verite1979-08-22
LEVINE EMB AGAR (K791519)Isle Media and Sterile Products, Inc.1979-08-22
LAURYL TRYPTOSE BROTH (K791481)Isle Media and Sterile Products, Inc.1979-08-22
PHENYLETHANOL AGAG (PEA) (K791472)Isle Media and Sterile Products, Inc.1979-08-22
ARGYLE TAUSSIG CULTURE CATHETER (K791327)Sherwood Medical Co.1979-08-22
RESUSCI-BAG-VALVE (K791468)Concept, Inc.1979-08-22
MACCONKEY MEDIA (K791482)Isle Media and Sterile Products, Inc.1979-08-22
EMB AGAR (EOSIN METHYLENE BLUE AGAR) (K791520)Isle Media and Sterile Products, Inc.1979-08-22
TRIPLE SUGAR IRON AGAR (TSI AGAR) (K791473)Isle Media and Sterile Products, Inc.1979-08-22
TRANSPORT MEDIUM STUART (K791514)Isle Media and Sterile Products, Inc.1979-08-22
MODIFIED THAYER-MARTIN MEDIUM (K791470)Isle Media and Sterile Products, Inc.1979-08-22
SS AGAR (SALMONELLA SHIGELLA AGAR) (K791480)Isle Media and Sterile Products, Inc.1979-08-22
SELENITE BROTH (K791484)Isle Media and Sterile Products, Inc.1979-08-22
CULTURE MEDIA FOR INSOLATION NEISSERIA (K791398)Isle Media and Sterile Products, Inc.1979-08-22
MUELLER HINTON AGARS (K791485)Isle Media and Sterile Products, Inc.1979-08-22
BIGGY AGAR (K791518)Isle Media and Sterile Products, Inc.1979-08-22
THAYER-MARTIN MEDIUM (K791483)Isle Media and Sterile Products, Inc.1979-08-22
TRANSPORT MEDIUM STUART W/ CHARCOAL (K791515)Isle Media and Sterile Products, Inc.1979-08-22
MODEL 6500 EXTRACTION IRRIGATION SYS (K791277)Cavitron Corp.1979-08-22
TRYPTIC SOY AGAR (K791516)Isle Media and Sterile Products, Inc.1979-08-22
WOMED NICRO-CRAFT POWER SYSTEM (K791407)Xomed, Inc.1979-08-22
GLUCOHEMOGLOBIN CONTROL (K791428)Bd Becton Dickinson Vacutainer Systems Preanalytic1979-08-22
ANTISERUM TO HUMAN IG G FC FRAGMENTS (K790708)Kent Laboratories, Inc.1979-08-22
COLUMBIA BLOOD AGAR (K791517)Isle Media and Sterile Products, Inc.1979-08-22
SELENITE CYSTINE BROTH (K791471)Isle Media and Sterile Products, Inc.1979-08-22
ANTI-BLASTOMYCES SERUM #CF10027X (K791390)Immuno-Mycologics, Inc.1979-08-16
CATALOG #4-2520 CHLORIDOMETER CHLORIDE (K791312)Buchler Instruments, Inc.1979-08-16
MANUAL MICRO ELISA READER #2-530 (K791302)Dynatech Laboratories, Inc.1979-08-16
HISTOPLASMA MYCELIAL #CF10020X (K791394)Immuno-Mycologics, Inc.1979-08-16
FUNGAL IMMUNODIFFUSION KIT #ID1001 (K791384)Immuno-Mycologics, Inc.1979-08-16
ANTISERUM TO HUMAN, ALPHA-2-MACROGLOBULI (K790712)Kent Laboratories, Inc.1979-08-16
ELECTROSURGICAL GENERATOR (TIM) (K791230)Concept, Inc.1979-08-16
GASTRIC LAVAGE KIT-DISPOSABLE (K791400)Acumed Instruments Corp.1979-08-16
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Track 1979 automatically

Every clearance here is in the API, with alerts when new ones post.