Atlas FDA

1979

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

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RecordFirmDate
5880 SERIES OF GAS CHROMATOGRAPHS (K791138)Hewlett-Packard Co.1979-07-24
ANTI-DNASE B REAGENT SYSTEM (K790997)Calbiochem-Behring Corp.1979-07-24
OPERATION MICROSCOPE SOM 1 (K791280)Elmed, Inc.1979-07-24
BATTERY CHARGER, 171 PACEMAKER (K782162)Telectronics, Inc.1979-07-24
SECUTE ELBOW BAND (K791248)Conphar, Inc.1979-07-24
PLUS CHEM S.C.E. REAGENT (K791080)Smithkline Diagnostics, Inc.1979-07-24
SECUTEX KNEE BAND (K791266)Conphar, Inc.1979-07-24
GIZMO TOWEL CLAMP (K791289)Hemoy, Inc.1979-07-24
BRIOX MODEL 2000-A ASPIRATOR UNIT (K791239)Briox Technologies, Inc.1979-07-24
SECUTEX ANKLE BAND (K791267)Conphar, Inc.1979-07-24
B & L OPHTHALMIC CHAIR (K791105)Bausch & Lomb, Inc.1979-07-24
BRIOX MODEL 2000-C COMPRESSOR UNIT (K791240)Briox Technologies, Inc.1979-07-24
BRIOX MODEL 2000-CQ QUIET COMPRESSOR (K791238)Briox Technologies, Inc.1979-07-24
CONPHAR OXYGEN CATHETER-STERILE (K791273)Conphar, Inc.1979-07-24
PROGESTERONE RADIOIMMUNOASSAY KIT (K791051)Cis Radiopharmaceuticals, Inc.1979-07-24
CONPHAR NASAL OXYGEN CANNULA-STERILE (K791247)Conphar, Inc.1979-07-24
SECUTEX WRIST BRACE (K791249)Conphar, Inc.1979-07-24
SPIN CHEM, DETERMINATION OF ALT (GPT) (K791083)Smithkline Diagnostics, Inc.1979-07-17
AMYLASE REAGENT SET (K790797)Alta Diagnostics, Inc.1979-07-17
ABNORMAL PROTEIN ELECTROPHORESIS CONTROL (K791031)Beckman Instruments, Inc.1979-07-17
BRAIN HEART INFUSION WITH AGAR BROTH (K791292)Isle Media and Sterile Products, Inc.1979-07-17
ECHO CARDIOGRAM PAD (K791189)Alimed, Inc.1979-07-17
NORMAL PROTEIN ELECTROPHORESIS CONTROL (K791029)Beckman Instruments, Inc.1979-07-17
BRAIN HEART INFUSION BROTH (K791194)Isle Media and Sterile Products, Inc.1979-07-17
LIPASE REAGENT SET (K790796)Alta Diagnostics, Inc.1979-07-17
PLUS CHEM, DETERMINATION OF ALT (GPT) (K791084)Smithkline Diagnostics, Inc.1979-07-17
MODEL CE-DM-II HEARING INSTRUMENT (K791126)Marcon Hearing Instruments, Inc.1979-07-17
CARY 210 SERIES, SPECTROPHOTOMETER (K791102)Varian Assoc., Inc.1979-07-17
RABBIT ANTISERUM TO HUMAN CHORIONIC (K790864)Pcl-Ria, Inc.1979-07-17
FERMCOTEST R BUN RATE REAGENT TEST KIT (K791018)Fermco Biochemics, Inc.1979-07-17
HEMATRAK MODEL 480 (K790816)Geometric Data, Div. Smithkline Corp.1979-07-17
HUMAN CHORIONIC GONADOTROPHIN STANDARDS (K790863)Pcl-Ria, Inc.1979-07-17
SPIN CHEM REAGENT, DETERMINATION OF AST (K791082)Smithkline Diagnostics, Inc.1979-07-17
GAMMADAB (125 1) FOLATE RADIOASSAY KIT (K791079)Clinical Assays, Inc.1979-07-17
P.A.P. RIA CONTROL SERUM PACK (K790985)Mallinckrodt Critical Care1979-07-17
TRYPTIC SOY BROTH (K791171)Isle Media and Sterile Products, Inc.1979-07-17
NUTRIENT BROTH (K791193)Isle Media and Sterile Products, Inc.1979-07-17
CONTEXT FILTER (K791108)Geometric Data, Div. Smithkline Corp.1979-07-17
SPIN CHEM REAGENT, DETERMINATION OF LDH- (K791081)Smithkline Diagnostics, Inc.1979-07-17
PLUS CHEM, DETERMINATION OF LD (LDH-P) (K791085)Smithkline Diagnostics, Inc.1979-07-17
BRAIN HEART INFUSION WITH BROTH (K791291)Isle Media and Sterile Products, Inc.1979-07-17
SICKLE-CELL F TEST (K791143)Isolab, Inc.1979-07-17
PERMANENT LEAD INTRADUCER (K791129)Daig Corp.1979-07-17
LABELED HUMAN CHORIONIC GONADOTROPHIN (K790876)Pcl-Ria, Inc.1979-07-17
POPE OTO-WICK, STERILE & NON-STERILE (K791059)Xomed, Inc.1979-07-17
CONCEPT II (K790339)Richardson Merrel, Inc.1979-07-17
SWAN-GANZ FLOW-DIRECTED CATHETER (K791183)Edwards Lifesciences, LLC1979-07-12
SURG-O-PAK, GOWNS, SHEETS, AND TOWELS (K780627)Convertors1979-07-11
SHERWOOD NEBULIZER KIT (K791089)Sherwood Medical Co.1979-07-10
DEXIDE DISPOSABLE PREP SPONGE (K791166)Dexide, Inc.1979-07-10
ARCOLITH 4000 (K791165)Arco Medical Products Co.1979-07-10
HYPER CHEC, SPHYGMOMANOMETER ELECTRONIC (K791054)C.R. Bard, Inc.1979-07-10
MIDDLE EAR PICKS, HOOKS CURETTES, (K791120)Xomed, Inc.1979-07-10
BIFLEX TM TEMPORARY PACING PROBE (K790983)Advanced Medical Concepts, Inc.1979-07-10
PREGELLED DISPOSABLE ECG ELECTRODES (K791139)Hayes Products, Inc.1979-07-10
EAR AND NOSE SPECULA (K791123)Xomed, Inc.1979-07-10
PREGELLED DISPOSABLE EELCTRO. SERIES 600 (K791140)Hayes Products, Inc.1979-07-10
TISSURE RETRACTORS (K791122)Xomed, Inc.1979-07-10
SENSOMAT SIDEARM ADAPTER (K790597)Biochem International, Inc.1979-07-10
CPR CONTROL SYSTEM (K791145)Pepin Distributing, Inc.1979-07-10
STETHOSCOPE WITH TEMPERATURE SENSOR (K791190)National Catheter Co. Div. Mallinckrodt1979-07-06
MODEL BP-2000 TIME-CYCLED VENTILATOR (K791186)Bourns Medical Systems, Inc.1979-07-06
COMPOSITE RESTORATIVE, PASTE/PASTE TYPE (K790789)Scientific Pharmaceuticals, Inc.1979-07-06
ANTERIOR/POSTERIOR RESTORATIVE LIQUID (K790822)Scientific Pharmaceuticals, Inc.1979-07-06
FISSURE SEALER AND BONDING AGENT (K790788)Scientific Pharmaceuticals, Inc.1979-07-06
PAINT-ON RESTORATIVE, LIGHT CURED (K790963)Scientific Pharmaceuticals, Inc.1979-07-06
SEAL & BOND DIRECT BONDING ORTHODONTIC (K790962)Scientific Pharmaceuticals, Inc.1979-07-06
MODEL H63, BEHIND-THE-EAR (K790870)Marcon Hearing Instruments, Inc.1979-07-05
MEDTRONIC MODEL 6957 (K790429)Medtronic Vascular1979-07-05
CAM-10 BATTERY PACK (#7-001) (K791188)Lifecare Services, Inc.1979-07-05
TEGTMEIER MAMMOMETER (K791221)Aztec Medical Products, Inc.1979-07-03
SURGICAL FACE MASK (K790970)Carapace, Inc.1979-07-03
FLOW LIMITER (K791017)Timeter Instrument Corp.1979-07-03
SILASTIC INTRAVENOUS CATHETER UNIT (K790914)Dow Corning Corp. Healthcare Industries Materials1979-07-03
CAM-10 PVV PORTABLE VOLUME VENTILATOR (K791033)Lifecare Services, Inc.1979-07-03
STIMTECH NEUROMUSCULAR STIMULATOR, C 600 (K791048)Stimulation Technology, Inc.1979-07-03
STIMULATOR, ELECTRICAL NERVE (K791158)Electreat, Inc.1979-07-03
RESPIRAOTR, CAM-10 RBL (K790605)Lifecare Services, Inc.1979-07-03
AIRCRAFT TRANSIT ISOLATOR MODEL 121 (K790658)Vickers America Medical Corp.1979-07-03
STRETCHER TRANSIT ISOLATER #122 (K790657)Vickers America Medical Corp.1979-07-03
CENTRY 2 SYSTEM #016, 103, 016, 104 (K791086)Cobe Laboratories, Inc.1979-07-03
MODEL MA3 BEHIND-THE-EAR MASKER/HEARING (K791071)Starkey Laboratories, Inc.1979-07-03
120 WELL HISTO-PLATE (K790958)Dynatech Laboratories, Inc.1979-06-28
MULTECON BLOOD GAS CONTROL (K790813)Ortho Diagnostics, Inc.1979-06-28
COULTER ACCU-ZYME IIY-GT REAGENT KIT (K790812)Coulter Electronics, Inc.1979-06-28
UV URIC ACID DETERMINATION (K790834)The Dow Chemical Co.1979-06-28
CITRATE AGAR GEL AND BUFFER SET (K790944)Corning Medical & Scientific1979-06-28
HPL RIA KIT (K790919)Technia Diagnostics , Ltd.1979-06-28
LYOPHILIZED G-HB QUIK COLUMN CONTROL (K791135)Helena Laboratories1979-06-28
LANCER HDL SEPARATION KIT (K790865)Sherwood Medical Co.1979-06-28
DIMENSIONALL ROTATOR (K790753)American Hospital Supply Corp.1979-06-28
THYROID CONTROL SERA CODE QAS.101 (K790840)Amersham Corp.1979-06-28
SYNALON ROLLER BOTTLE (K791049)Dynatech Laboratories, Inc.1979-06-28
BIOVATION DIGITAL URINOMETER (K790862)Biovation, Inc.1979-06-28
AUTO ENZYMATIC CHOLESTEROL (K790947)Macomb Chemical Co.1979-06-28
LOW IONIC STRENGTH SOLUTION (LISS) (K791113)Hyland Therapeutic Div., Travenol Laboratories1979-06-28
PROTHROMBIN FREE BEEF PLASMA (PFB) (K791023)Pacific Hemostasis1979-06-28
LEECO GLYCO-HEMOGLOBIN DIAGNOSTIC KIT (K791103)Leeco Diagnostics, Inc.1979-06-28
ULTRA-FREE (K790445)Millipore Corp.1979-06-28
RF CONTROLS (K790986)Wampole Laboratories1979-06-28
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Every clearance here is in the API, with alerts when new ones post.