Atlas FDA

1980

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

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RecordFirmDate
SKIN STAPLE REMOVER #523770 (K801444)Edward Weck, Inc.1980-07-14
CARDIOTOMY RESERVOIR WITH FILTER (K801360)Travenol Laboratories, S.A.1980-07-14
HELENA ULTRA SENSITIVE CPK REAGENT/DILUE (K801318)Helena Laboratories1980-07-14
HI-M-TEST FOR METHADONE TEST #2 (K801509)Technam, Inc.1980-07-14
PRE-DENT SYSTEM MODIFIED (K801516)Pre-Dent System1980-07-14
DISC 120 TRANSPORTER (K801391)Travenol Laboratories, S.A.1980-07-14
BECKMAN MODEL 42 SPECTROPHOTOMETER (K801373)Beckman Instruments, Inc.1980-07-14
EZ ON SAFETY PONCHO (K801489)Skil-Care Corp.1980-07-14
PORTA-FIB LPD (K801544)Narco Bio-Systems1980-07-14
SHILEY CARDIOTOMY RESERVOIR W/FILTER (K801375)Shiley, Inc.1980-07-14
TIMETER PRODUCED PURRITAN BENNETT O2 ADP (K801514)Timeter Instrument Corp.1980-07-14
STERILE, DISP DOME, INDIVID. PKG. (K801239)Pacific Domes, Inc.1980-07-14
ACUVAC(TM) SUCTION RESERVOIR 400CC AND (K801350)Innovative Surgical Products, Inc.1980-07-14
MODEL P-380 PHYSIOLOGICAL PRESSURE TRAN. (K801138)Gics Pharmaceuticals1980-07-14
AMBULATORY INFUSION PUMP, CODE 2M9807 (K800627)Travenol Laboratories, S.A.1980-07-14
WHITE BLOOD CELL COUNT CONTROL LEVELS (K801265)Bioscientific1980-07-14
HEMOGLOBIN CONTROL LEVELS (K801268)Bioscientific1980-07-14
LARES AIR PRESSURE GAUGE (K801534)Lares Manufacturing Co., Inc.1980-07-14
P-S SUCTION RESERVOIR (K801443)Pudenz-Schulte Medical Research Corp.1980-07-14
HIPP BUFFER(NON-BARBITAL), P/N (K801378)Gelman Sciences, Inc.1980-07-14
RED BLOOD CELL COUNT & HEMATOCRIT CNTL (K801267)Bioscientific1980-07-14
ACCU-CORE DISPOSABLE BIOPSY NEEDLE (K801457)Medline Industries, Inc.1980-07-14
DIGOXIN EIA KIT (K801490)M.A. Bioproducts1980-07-14
SKIN STAPLER HANDLE 523700/CARTRIDGES (K801445)Edward Weck, Inc.1980-07-14
GAMMADAB B-HCG RADIOIMMUNOASSAY KIT (K801409)Travenol Laboratories, S.A.1980-07-14
COBE HEMOFLO BLOOD TUBING SETS (K801211)Cobe Laboratories, Inc.1980-07-14
OROTRACHEAL INTUBATION ENDOSCOPE (K801452)Olympus Corp.1980-07-14
DISPOSABLE ARTICULATOR (K801342)Williams Gold Refining Co., Inc.1980-07-08
HEMOPEXIN NEPHELOMETRIC ASSAY (K801432)J.T. Baker Chemical Co.1980-07-08
NITRATE SWAB-RAPID TEST (K800803)Remel Co.1980-07-08
TEST FOR KETONE IN URINE(ACETOACETIC AC (K801270)Miles Laboratories, Inc.1980-07-08
BIONICS ARTERIAL/VENOUS FISTULA NEEDLE (K801354)Cordis Corp.1980-07-08
CONTROL SYRINGE (K801430)Abco Dealers, Inc.1980-07-08
APPLICATION OF EMIT AED ASSAYS (K801475)Syva Co.1980-07-08
ADAPTAID ELEMA LEAD ADAPTER KIT 365-17 (K801038)Intermedics, Inc.1980-07-08
SERALYZER BLOOD UREA NITROGEN(BUN) (K801269)Miles Laboratories, Inc.1980-07-08
PORTA-NEB(R) 310 (K801286)E.B.E. Research & Mfg., Inc.1980-07-08
J.T. BAKER TRANSFERRIN NEPHELOMETRIC ASS (K801434)J.T. Baker Chemical Co.1980-07-08
EC-4 PLETHYSMOGRAPH (K801291)D. E. Hokanson, Inc.1980-07-08
COBAS REAGENT FOR TRIGLYCERIDES & COBAS (K801298)Roche Analytical Instruments, Inc.1980-07-08
APPLICATION OF EMIT THEOPHYLLINE ASSAY (K801476)Syva Co.1980-07-08
BIONICS BI-FLO SAFE(DOUBLE LUMEN CATHET (K801356)Cordis Corp.1980-07-08
AMERLEX DIGOXIN RIA KIT (K801413)Amersham Corp.1980-07-08
COBAS REAGENT FOR A-AMYLASE (K801295)Roche Analytical Instruments, Inc.1980-07-08
MULTICOR (GAMMA) MODEL 336 & MODEL 337 (K801106)Cordis Corp.1980-07-08
COLLIMAX X-RAY COLLIMATOR # R-182 (K801168)Ito X-Ray Corp.1980-07-08
CROWN DELTA SILICONE IMPRESSION MATERIAL (K801380)Crown Delta Corp.1980-07-08
HAPTOGLOBIN NEPHELOMETRIC ASSAY (K801433)J.T. Baker Chemical Co.1980-07-08
GAMMA PROLACTIN RADIOIMMUNOASSAY KIT- (K801020)Travenol Laboratories, S.A.1980-07-08
VASCULAB BI-DIRECTIONAL DOPPLER, #D10 (K800768)Medasonics, Inc.1980-07-08
UNASSAYED CHEMISTRY SERUM CONTROL(BOVINE (K801335)Warner-Lambert Co.1980-07-08
SANDARE LYOPHILIZED GLYCOHEMOGLOBIN CLS. (K801422)Sandare Chemical Co., Inc.1980-07-08
ABBY II PATIENT MONITOR OR VITAL SIGNS M (K801515)Abbott Medical Electronics Co.1980-07-08
HEMORRHOIDAL LIGATION INSTR. SYSTEM (K801352)Depuy, Inc.1980-07-08
BIONICS BI-FLO STRETCH(DOUBLE LUMEN FOR (K801355)Cordis Corp.1980-07-08
AVL #980 ELECTROLYTE ANALYZER (K801011)Gauntlet Technology Corp.1980-07-08
KAMPNER HINGED TOE PROSTHESIS (K801345)Biomedics1980-07-08
SERIES 602 CKG RECORDER (MODIFIED) (K801485)Cardio Kinetics, Inc.1980-07-08
ASO QUANTUM, ANTISTREPTOLYSIN O TEST (K801177)Sclavo, Inc.1980-07-08
DUPONT 'ACA' CONJUGATED BILIRUBIN(CBIL) (K801300)E.I. Dupont DE Nemours & Co., Inc.1980-07-08
REIGNING EPOXY RESIN CEMENT (K801236)Oki Shiks USA , Ltd.1980-07-08
MYELOSTAT DORSAL CORD STIMULATOR, ETC. (K801384)Medtronic Vascular1980-07-08
HIPPUR-ASE TUBES (K800816)Microchemical Specialities, Co.1980-07-08
GE LEAD ADAPTER, MODEL 345-01 (K801040)Intermedics, Inc.1980-06-30
CARDIOPULMONARY BYPASS TUBING (K801401)Texas Medical Products, Inc.1980-06-30
ALIZARIN SULFONATE, CALCIUM (K801290)Union Carbide Corp.1980-06-30
SAPHENOUS VEIN CANNULAE (K801396)Texas Medical Products, Inc.1980-06-30
PARKE-DAVIS SURGICAL LIGHT (K801353)Warner-Lambert Co.1980-06-30
COMPLEMENT C4 NEPHELOMETRIC ASSAY (K801361)J.T. Baker Chemical Co.1980-06-30
VASCULAR CLAMP (K801395)Texas Medical Products, Inc.1980-06-30
PERMANENT & TEMP. PACEMAKER ELECTRODE (K800795)Daig Corp.1980-06-30
RUBELLA BIO-BEAD TITRATION KIT (K800789)Litton Bionetics1980-06-30
DISPOSABLE PERFUSION CONNECTORS (K801405)Texas Medical Products, Inc.1980-06-30
WAKO PHOSPHOLIPIDS TEST (K801076)Wako Pure Chemical Industries, Ltd.1980-06-30
COMPLEMENT C3 NEPHELOMETRIC ASSAY (K801363)J.T. Baker Chemical Co.1980-06-30
COBAS REAGENT FOR CHOLESTEROL (K801296)Roche Analytical Instruments, Inc.1980-06-30
GF120H DIALYZER (K801045)Gambro, Inc.1980-06-30
UNIPOLAR PROGRAMMABLE LITHIUM CARD. GEN. (K801241)Arco Medical Products Co.1980-06-30
CO2 LASER (K801197)Advanced Biomedical Instruments1980-06-30
DISPOSABLE SUMP SETS (K801392)Texas Medical Products, Inc.1980-06-30
SIEMENS-ELECTROGERATE GMBH MICRO-INHALER (K800830)Macbeth Sales Corp.1980-06-30
COBAS REAGENT FOR GLUCOSE RAPID (K801297)Roche Analytical Instruments, Inc.1980-06-30
CARDIOPULMONARY BYPASS PUMP TUBING (K801394)Texas Medical Products, Inc.1980-06-30
AIR ASPIRATOR NEEDLE (K801393)Texas Medical Products, Inc.1980-06-30
MICROTHIN-D1 (MOD. 0620) (K801122)Cardiac Pacemakers, Inc.1980-06-30
SER-TEX (K800834)V.S.S.I., Inc.1980-06-30
BEL O SOL UVA SUNLAMP DEVICE (K801149)Hopeful Sunlamp Corp.1980-06-30
QUICKIE PRIME CARDIOP. BYPASS PERF. INTR (K801402)Texas Medical Products, Inc.1980-06-30
AORTIC AND FEMORAL PERFUSION CANNULAE (K801398)Texas Medical Products, Inc.1980-06-30
DISPOSABLE PARALLEL Y CONNECTORS (K801404)Texas Medical Products, Inc.1980-06-30
MEDI-TRACE DISP. LINES FOR PHYSIO. PRESS (K801322)Graphic Controls Corp.1980-06-30
DISPOSABLE SUCKER SYSTEM (K801400)Texas Medical Products, Inc.1980-06-30
DISPOSABLE PERFUSION SET (K801403)Texas Medical Products, Inc.1980-06-30
LEECO GLYCO-HEMOGLOBIN DIAG. TEST KIT (K801289)Leeco Diagnostics, Inc.1980-06-30
CLINICAL AUDIOMETER MODEL TA-200 (K801325)Teledyne Avionics Div. of Teledyne1980-06-30
MICROTHIN-P1 (MOD. 0622) (K801121)Cardiac Pacemakers, Inc.1980-06-30
J.T. BAKER IMMUNO. M. NEPHELOMETRIC ASSA (K801282)J.T. Baker Chemical Co.1980-06-30
PACKAGE FOR MEDI-TRACE PHYSIOLOGICAL PRE (K801321)Graphic Controls Corp.1980-06-30
VENA CAVA CANNULAE (K801397)Texas Medical Products, Inc.1980-06-30
EMIT AAII THYROXINE ASSAY (K801288)Syva Co.1980-06-30
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Every clearance here is in the API, with alerts when new ones post.