Atlas FDA

1980

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

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RecordFirmDate
SODIUM/POTASSIUM 140/5 MEQ/L) (K800041)Gilford Diagnostics1980-01-21
LITHIUM DILUENT (1500 MM/E) (K800039)Gilford Diagnostics1980-01-21
LDC UVIII FIXED WAVELENGTH ULTRAVIOLET (K800047)Laboratory Data Control1980-01-21
WORK SIMULATOR (K800007)Baltimore Therapeutic Equipment Co.1980-01-21
LIVERPOOL KNEE PROSTHESIS (K792325)Downs Surgical , Ltd.1980-01-21
WORTHINGTON FLOZYME* CPK (340NM) (K800028)Worthington Diagnostic Systems1980-01-21
SODIUM/POTASSIUM (100/100 MEQ/E) (K800040)Gilford Diagnostics1980-01-21
DUPONT ACA ION SELECTIVE ELECTRODE (K800016)E.I. Dupont DE Nemours & Co., Inc.1980-01-21
PENTEX LIPOPROTEIN CHOLESTEROL SOLU. (K800035)Miles Laboratories, Inc.1980-01-21
TOTAL ESTRIOL RIA KIT (K800036)Amersham Corp.1980-01-21
CRYPTOCOCCUS NEOFORMANS ANTISERUM, LATEX (K792693)Meridian Diagnostics, Inc.1980-01-21
SMV 120 SONIC MAMMOGRAPHIC VIEWER (K792585)Johnson & Johnson Professionals, Inc.1980-01-21
CENTRIA FSH RIA (K792233)Union Carbide Corp.1980-01-21
COCCIDIOIDES IMMITIS, ANTISERUM POS. (K792717)Meridian Diagnostics, Inc.1980-01-17
COCCIDIOIDES IMMITIS, ANTISERUM (K792688)Meridian Diagnostics, Inc.1980-01-17
COCCIDIOIDES IMMITIS, LATEX AGGLUTI (K792690)Meridian Diagnostics, Inc.1980-01-17
ASPERGILLUS SP, ANTISERUM POSITIVE (K792686)Meridian Diagnostics, Inc.1980-01-17
COBAS-BLO REAGENTS (LACTATE DEHYDRO (K792658)Hoffmann-La Roche, Inc.1980-01-17
ANALYTE CORTISOL (K792439)Technicon Instruments Corp.1980-01-17
NON ADHERANT WOUND BANDAGES (K800020)American Medical Disposable, Inc.1980-01-17
HISTOPLASMA CAPSULATUM, ANTISERUM (K792679)Meridian Diagnostics, Inc.1980-01-17
BLASTOMYCES DERMATITIDIS, ANTISERUM (K792685)Meridian Diagnostics, Inc.1980-01-17
BLASTOMYCES DERMATITIDIS, ANTIGEN (K792680)Meridian Diagnostics, Inc.1980-01-17
ASPERGILLUS SP., ANTIGEN (K792687)Meridian Diagnostics, Inc.1980-01-17
HISTOPLASMA CAPSULATUM, MYCELIAL PHASE (K792708)Meridian Diagnostics, Inc.1980-01-17
COCCIDIOIDES IMMITIS, ANTIGEN (K792689)Meridian Diagnostics, Inc.1980-01-17
VENOJECT AUTOSEP (K792587)Kimble-Terumo, Inc.1980-01-17
COCCIDIOIDES IMMITIS, ANTIGEN (K792682)Meridian Diagnostics, Inc.1980-01-17
AUTOPAK-12 UPTAKE TEST DELIVERY SYSTEM (K792662)Micromedic Systems1980-01-17
HEMO-WEDGE (K790555)Parker Laboratories, Inc.1980-01-17
HISTOPLASMA CAPSULATUM, ANTISERUM (K792718)Meridian Diagnostics, Inc.1980-01-17
BLASTOMYCES DERMATITIDIS POS/CONTROL (K792681)Meridian Diagnostics, Inc.1980-01-17
COCCIDIOIDES IMMITIS, ANTISERUM, (K792684)Meridian Diagnostics, Inc.1980-01-17
COBAS-BIO CENTRIFUGAL ANALYZER (K792671)Hoffmann-La Roche, Inc.1980-01-17
HISTOPLASMA CAPSULATUM, ANTIGEN YEAST (K792704)Meridian Diagnostics, Inc.1980-01-17
HISTOPLASMA CAPSULATUM, ANTISERUM (K792711)Meridian Diagnostics, Inc.1980-01-17
NON ADHERANT NEUROLOGICAL SPONGES (K800021)American Medical Disposable, Inc.1980-01-17
ASPERGILLUS SP, COMPLEMENT FIXATION (K792700)Meridian Diagnostics, Inc.1980-01-17
DOW CORNING/W RIGHT WOUND DRAINAGE SYS (K800014)Dow Corning Corp. Healthcare Industries Materials1980-01-17
PARA-PAK (C&S) (K792712)Meridian Diagnostics, Inc.1980-01-17
SONACOLOR 6000 (K792540)Carolina Medical Electronics1980-01-17
ASPERGILLUS SP, ANTISERUM, POSITIVE (K792698)Meridian Diagnostics, Inc.1980-01-17
CRYPTOCOCCUS NEOFORMANS, ANTIGEN, (K792691)Meridian Diagnostics, Inc.1980-01-17
RIA-QUANT CK-MB TEST KIT (K792504)Mallinckrodt Critical Care1980-01-16
ELVI MUCAPROTEINS (K792554)Volu Sol Medical Industries1980-01-16
CHLORIDE REAGENT (K792605)Gilford Diagnostics1980-01-16
ELVI NON-ESTERIFIED FATTY ACIDS (K792555)Volu Sol Medical Industries1980-01-16
NEOCHROME II GLUCOSE, #4044 (K792534)American Monitor Corp.1980-01-16
CK-MB (CREATINE KINASE-MB) RIA CONTROL (K792524)Mallinckrodt Critical Care1980-01-16
TRIIODOTHYRONINE RIA SYSTEM (K792539)Radioimmunoassay, Inc.1980-01-16
T3 UPTAKE (T3U) REAGENTS (K792607)Dade, Baxter Travenol Diagnostics, Inc.1980-01-16
MULTIPLE AUTO ANTIBODY TEST (K791996)Meda Stat Diagnostics, Inc.1980-01-16
CENTRIA LH RIA (K792350)Union Carbide Corp.1980-01-16
BAKER INTESTINAL TUBE, TWIN CUFF (K792333)Intl. Hospital Products, Inc.1980-01-16
SENSI-SLIDE (K792657)Hoffmann-La Roche, Inc.1980-01-16
3&4 WAY PLASTIC STERILE STPCKS. PKG. (K792126)Tronomed, Inc.1980-01-16
PONCEAU S STAIN SET (K792550)Electrophoresis Corp. of America1980-01-16
NASO STENT (K792556)Tripedsil, Inc.1980-01-16
MODEL 7620 LINE CLAMP (K792277)B-D Drake Willock1980-01-16
SPECTROPHATOMETER MODELS 2280 & 2380AA (K792557)The Perkin-Elmer Corp.1980-01-16
STERILIZATION PROCESS/BULB SYRINGE (K792632)Procter & Gamble Mfg. Co.1980-01-16
STERILIZATION PROCESS/PLACENTA BASIN (K792625)Procter & Gamble Mfg. Co.1980-01-16
POLY-LEC SYSTEM (K792582)Gamma Biologicals, Inc.1980-01-16
ELVI-AMINOLEVULINIC ACID (K792407)Volu Sol Medical Industries1980-01-16
CSF-VENTRICULAR CATHETER, STANDARD DES (K792007)Pudenz-Schulte Medical Research Corp.1980-01-16
LEUKOCLIP POROS (K792667)Beiersdorf, Inc.1980-01-16
STERILIZATION PROCESS/BABY BLANKET (K792626)Procter & Gamble Mfg. Co.1980-01-16
TIPSEP-T4(RIA) T4 RADIOIMMUNOASSAY (K792599)Nuclear Diagnostics, Inc.1980-01-16
DISPOSABLE TEMPERATURE PROBE (K792426)Hospitak, Inc.1980-01-16
CSF-CARDIAC/PERITONEAL CATHETER (K792005)Pudenz-Schulte Medical Research Corp.1980-01-16
LEECO P.A.P. QUANT. DIAGNOSTIC KIT (K792652)Leeco Diagnostics, Inc.1980-01-16
LEUKOPOR (K792666)Beiersdorf, Inc.1980-01-16
IMMUNOSTAT TSH TEST (K792562)Meloy Laboratories, Inc.1980-01-16
TANDEM ASSEMBLED 3&4 WAY STOPCOCKS (K792124)Tronomed, Inc.1980-01-16
SURGIFEED (K791714)Health Development Corp.1980-01-16
GAMMA ARACHIS HYPOGEA LECTIN (K792583)Gamma Biologicals, Inc.1980-01-16
SORB SYSTEM URS (K792137)Organon Teknika Corp.1980-01-16
HYPO-ALLERGENIC PLASTIC TAPE (K792136)National Patent Development Corp.1980-01-16
3&4 WAY PLASTIC STOPCOCKS, NONSTERILE (K792125)Tronomed, Inc.1980-01-16
YSI SERIES 500 THERMISTOR PROBES (K792116)Yellow Springs Instrument Co., Inc.1980-01-16
VENTED I.V. SET (K792228)Abbott Laboratories1980-01-16
CONCEPTROL/THIN PROPHYLACTICS (K792634)Ortho Pharmaceutical Corp.1980-01-16
GENERAL ELECTRIC PANELIPSE LD (K792581)General Electric Co.1980-01-16
STERILE EXTENSION TUBES INDIV. PKG. (K792128)Tronomed, Inc.1980-01-16
C-DAK 2100 ARTIFICIAL KIDNEY (K792419)Cordis Corp.1980-01-16
PLAS. STCK. W/EXTENSION TUBE/STERILE (K792127)Tronomed, Inc.1980-01-16
3 WAY URETHRAL IRRIGATION CATHETER (K792719)Vesta, Inc.1980-01-16
IMPLANTABLE BIPOLAR CARDIAC PULSE GEN. (K800030)Telectronics, Inc.1980-01-11
STERILIZATION PROCESS /USE GOWNS (K792622)Procter & Gamble Mfg. Co.1980-01-11
CENTRIA RADIOIMMUNOASSAY SEPARATION (K792636)Union Carbide Corp.1980-01-11
SANDARE CHLORIDE PROCEDURE (K792531)Sandare Chemical Co., Inc.1980-01-11
CENTRIA-SET TYPE D(ANTI-SHEEP/GOAT) (K792637)Union Carbide Corp.1980-01-11
THROMBOKINETIC FIBRINOGEN ASSAY (K792563)Bio/Data Corp.1980-01-11
STERILIZATION PROCESS/ABSORBENT TOWEL (K792623)Procter & Gamble Mfg. Co.1980-01-11
GLUCOSE (HEXOKINASE) REAGENT SET (K792532)Macomb Chemical Co.1980-01-11
CHEMISTRY ANALYZER REAGENTS (K792482)Laboratory Products, Inc.1980-01-11
AMBU UNIVERSAL SUCTION PUMP (K792592)Narco Air-Shields1980-01-11
ACA HIGH DENSITY LIPOPROTEIN CHOLES. (K792509)E.I. Dupont DE Nemours & Co., Inc.1980-01-11
CREATINE PHOSPHOKINASE (CPK) REAGENT SET (K792533)Macomb Chemical Co.1980-01-11
RUBELISA TEST KIT (K792133)Microbiological Assoc.1980-01-11
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