Atlas FDA

1979

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

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RecordFirmDate
SERACON-SRI (PROD. # D029 (K792486)Bhp Diagnostix, Inc.1979-12-31
CENTRIA FERRITIN RIA (K792449)Union Carbide Corp.1979-12-31
HELENA FACTOR XI DEFICIENT SUBSTRATE (K792476)Helena Laboratories1979-12-31
PLATELET-CHEX FOR BLOOD CENTERS (K792467)Streck Laboratories, Inc.1979-12-31
HANSAPOR STERILE (K792360)Beiersdorf, Inc.1979-12-31
DECARBOXYLASE BROTH BASE WITH OR WITH- (K792421)Isle Media and Sterile Products, Inc.1979-12-31
SIM MEDIUM (K792420)Isle Media and Sterile Products, Inc.1979-12-31
PHENYLETHANOL AGAR (K792593)Isle Media and Sterile Products, Inc.1979-12-31
AVL MODEL 940 AUTOMATIC PH/BLOOD GAS (K792230)Gauntlet Technology Corp.1979-12-31
HALO SUPPORT JACKET & ASSOC. HARDWARE (K792586)Depuy, Inc.1979-12-31
TRYPTIC SOY AGAR W/PHENYLETHANOL & (K792596)Isle Media and Sterile Products, Inc.1979-12-31
AGGLUTINOTEST-THYROGLOBULIN (K791458)Volu Sol Medical Industries1979-12-31
AGGLUTINOTEST-INFECTIOUS MONONUCLEOSIS (K791455)Volu Sol Medical Industries1979-12-31
LIFELINE TLE ENDOCARDIAL PACING LEAD, (K792604)Intermedics, Inc.1979-12-31
TRYPTIC SOY AGAR W/LECITHIN & POLYSRBTE. (K792594)Isle Media and Sterile Products, Inc.1979-12-31
TETRATHIONATE BROTH BASE (K792422)Isle Media and Sterile Products, Inc.1979-12-31
HELENA FACTOR V DEFICIENT SUBSTRATE (K792507)Helena Laboratories1979-12-31
H-H SHUNT INTRODUCER (K792639)Holter-Hausner Intl.1979-12-31
SANDARE CYANMETHEMOGLOBIN STANDARD (K792358)Sandare Chemical Co., Inc.1979-12-31
SERACON-SRI (K792485)Bhp Diagnostix, Inc.1979-12-31
ACA ETHOSURIMIDE TEST PACK (K792584)E.I. Dupont DE Nemours & Co., Inc.1979-12-31
SF MEDIUM (SF BROTH, STREPTOCOCCUS (K792595)Isle Media and Sterile Products, Inc.1979-12-31
ALARM USED W/MONITORING SPIROMETER (K792573)Empire Plastics Manufacturer1979-12-31
AGGLUTINOTEST-C-REACTIVE PROTEIN (K791461)Volu Sol Medical Industries1979-12-31
SANDARE CYANMETHEMOGLOBIN REAGENT (K792503)Sandare Chemical Co., Inc.1979-12-31
HELENA FACTOR VII DEFICIENT SUB. PLASMA (K792511)Helena Laboratories1979-12-31
HELENA FACTOR IX DEFICIENT SUBSTRATE (K792475)Helena Laboratories1979-12-31
PATIENT TROLLEY B49 (K792570)Ets Rene Marzet1979-12-31
LIFELIFT MODELS ONE AND TWO (K792601)Corda Int'L Holiday, Inc.1979-12-31
VOLU-SOL NMB RETICULOCYTE STAIN (K792496)Volu Sol Medical Industries1979-12-31
SERACON-SRII (K792487)Bhp Diagnostix, Inc.1979-12-31
VOGEL-JOHNSON AGAR (K792542)Isle Media and Sterile Products, Inc.1979-12-31
HELENA FACTOR X DEFICIENT SUBSTRATE (K792508)Helena Laboratories1979-12-31
AGGLUTINOTEST-RHEUMATOID ARTHRITIS (K791507)Volu Sol Medical Industries1979-12-31
CULTURE PLATES & TUBED MEDIA (K792481)Laboratory Products, Inc.1979-12-31
PIASMA SAFE (K792185)Cry-O-Safe, Inc.1979-12-28
PSORALITE MARK I (K791977)Paul B. Elder Co.1979-12-28
DECARBOXYLASE MOELLER BASE WITH OR WITH- (K792425)Isle Media and Sterile Products, Inc.1979-12-27
CHEM-STRATE AMYLASE (K792479)General Diagnostics1979-12-27
PLAQUE-X DENTURE CLEANER (K792530)Nexell Corp.1979-12-27
LYSINE IRON AGAR (K792544)Isle Media and Sterile Products, Inc.1979-12-27
RIONET HEARING AID HB-68L (K792506)Rion Acoustic Instruments, Inc.1979-12-27
MODEL 449 ELECTROCARDIOCORDER (K792078)Del Mar Avionics1979-12-27
RIONET HEARING AID HB-32T (K792505)Rion Acoustic Instruments, Inc.1979-12-27
INTRA-ARTICULATED EDGER-PLANER SYSTEM (K792353)Richard Wolf Medical Instruments Corp.1979-12-27
BACTEC BACTERIAL DETECTION SYSTEM (K792575)Bd Becton Dickinson Vacutainer Systems Preanalytic1979-12-27
DEXIDE DIS. SUR. SCRUB SPONGE W/PARACHLO (K792272)Dexide, Inc.1979-12-27
FEEDING TUBE PLACEMENT STYLET (K792468)Biosearch Medical Products, Inc.1979-12-27
TIPSEP-T3U TRIIODOTHYRONINE UPTAKE (K792484)Nuclear Diagnostics, Inc.1979-12-27
SYSTEM 103 CHEMISTRY ANALYZER (K792361)Gilford Instrument Laboratories, Inc.1979-12-27
CHOCOLATE TELLURITE AGAR (K792424)Isle Media and Sterile Products, Inc.1979-12-27
MODEL 674 PACER ANALYZER (K792074)Del Mar Avionics1979-12-27
TRYPTOSE BLOOD AGAR BASE & TRYPTOSE (K792543)Isle Media and Sterile Products, Inc.1979-12-27
CHEM-STRATE CK-NAC (K792477)General Diagnostics1979-12-27
MODEL 447 ELECTROCARDIOCORDER (K792079)Del Mar Avionics1979-12-27
HELENA FACTOR II DEFICIENT SUB. PLASMA (K792336)Helena Laboratories1979-12-27
PENTAX BROCHOFIBERSCOPE MODEL FB-17D, (K792342)Pentax Precision Instrument Corp.1979-12-27
CONTAINER SYSTEM (K792558)Aesculap Instruments Corp.1979-12-27
NORLAND MODEL 278 BONE DENSITOMETER (K792444)Norland Corp.1979-12-27
TSH RADIOIMMUNOASSAY (K792443)Dade, Baxter Travenol Diagnostics, Inc.1979-12-27
CHEM-STRATE TRIGLYCERIDE (K792480)General Diagnostics1979-12-27
REFEREE BFT BLOOD FOR TONOMETRY (K792447)Analytical Products, Inc.1979-12-27
VAGINAL PACKING (K792431)American Medical Disposable, Inc.1979-12-27
ELECTRO-IMMUNO-QUANTITATION (EIQ) (K792472)Icl Scientific1979-12-27
MODEL 448 PACERCORDER (K792076)Del Mar Avionics1979-12-27
CHEM-STRATE CHOLESTEROL (K792478)General Diagnostics1979-12-27
IREX CARDIOPLAN (K792525)Irex Corp.1979-12-27
THE ARALUEN CARRIER (K792566)Araluen, Inc.1979-12-20
TEMPORARY BURN SHEET WITH PERFORATED (K792433)American Medical Disposable, Inc.1979-12-20
POLYPHOS (K792392)Siemens Corp.1979-12-20
SORBIES (K792295)American Hospital Supply Corp.1979-12-20
INTEGRON (K792327)Tecnomed, Inc.1979-12-20
STONE AND RETRIEVAL BASKET (K792344)Mill-Rose Laboratory1979-12-20
SKIL-CARE TURN AND HOLD PAD (K792318)Skil-Care Corp.1979-12-20
MICROBAR MONITORING LINE FILTER (K792510)Medex, Inc.1979-12-20
TOMMY TOES (K792331)Tommy Toes1979-12-20
IMPLANTABLE PROGRAMMABLE UNIPOLAR (K792519)Telectronics, Inc.1979-12-20
GIGANTOS 1012 MP (K792393)Siemens Corp.1979-12-20
CONTINU-FLO ADMIN. SET CODE 2C/200 (K792538)Travenol Laboratories, S.A.1979-12-20
SPAN AIDS KIT (K792297)American Hospital Supply Corp.1979-12-20
RETRIEVABLE FORCEPS (K792345)Mill-Rose Laboratory1979-12-20
P1806 MOBILE C-ARM IMAGE INTENSIFIER (K792225)Precise Optics1979-12-20
THE VERSA-BED (K792298)First & Ten, Inc.1979-12-20
STANFORD STERILE LAP SPONGES (K792471)Lukens Corp.1979-12-20
POLAROID LAND CAMERA FOR ENDOSCOPY (K792512)Polaroid Corp.1979-12-20
TEMPORARY BURN SHEET WITH PERFORATED (K792432)American Medical Disposable, Inc.1979-12-20
ACCESSORIES FOR SYS. 400 CO2 SURG. LASER (K791895)Coherent Medical Division1979-12-20
STOMAHESIVE POWDER (K792382)E. R. Squibb & Sons, Inc.1979-12-20
OCTOSON (K792388)Ausonics Pty , Ltd.1979-12-20
THERAPETTE, MODEL NO MH-100 (K792473)Technical Resources, Inc.1979-12-20
MULTI-AD FLUID DISPENSING SYSTEM (K792227)National Patent Development Corp.1979-12-20
MASTER I.V. DIAL LOCK (K792560)The Master Medical Corp.1979-12-20
A SLEEP ASSESSMENT DEVICE (K792305)Farrall Instruments, Inc.1979-12-20
SIRCAM 106 (K792394)Siemens Corp.1979-12-20
CATHETERIZATION FORCEP (K792494)C. Intl.1979-12-20
BRAIN HEART INFUSION W/PABA, O.1%, (K792276)Bd Becton Dickinson Vacutainer Systems Preanalytic1979-12-19
CULTURIA EMB/COLUMBIA CNA W/5% SHEEP (K792284)Clinical Convenience Products, Inc.1979-12-19
CASTROVIEJO VASCULAR SCISSORS (K792576)Edward Weck, Inc.1979-12-19
MR-VP MEDIUM (K792286)Isle Media and Sterile Products, Inc.1979-12-19
AMS YEAST BIOCHEMICAL CARD (K792231)Vitek Systems, Inc.1979-12-19
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Track 1979 automatically

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