Atlas FDA

1980

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

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RecordFirmDate
CORONARY PERFUSION CONNECTOR PLUG (K801399)Texas Medical Products, Inc.1980-06-30
QUICKTAN BOOTH (K801129)Quicktan Mfg.1980-06-30
J.T. BAKER IMMUNO. A NEPHELOMETRIC ASSAY (K801283)J.T. Baker Chemical Co.1980-06-30
PROGRAMMABLE BIPOLAR CARDIAC GENERATOR (K800837)Arco Medical Products Co.1980-06-30
EMIT AAII THYROXINE CALIBRATORS (K801287)Syva Co.1980-06-30
KODAK MEDICAL X-RAY DEVELOPER & REPLEN. (K801209)Eastman Kodak Company1980-06-26
ARGYLE VAC-U-CARE FLAT SILICONE WOUND T. (K801371)Sherwood Medical Co.1980-06-26
REAGENTS FOR ASTRA 8 AUTOMATED ANALYZER (K801222)Simmler, Inc.1980-06-26
PET-SCOPE II MODEL DIS-1611 (K801166)Diagnostic Information, Inc.1980-06-26
DISPOSABLE SURGICAL HEAD SUPPORT (K801382)Innovative Surgical Products, Inc.1980-06-26
ANSPACH LEG SUPPORT (K801330)The Anspach Effort, Inc.1980-06-26
NUCLEAR ENTERPRISES 1600/GAMMA COUNTER (K801264)Nuclear Ent. , Ltd.1980-06-26
ARGYLE VAC-U-CARE 100CC SUCT. RESERVOIR (K801372)Sherwood Medical Co.1980-06-26
HI-TEMP SURGICAL CAUTERY (K801323)Medical Products Development, Inc.1980-06-26
HESSLER COLON THERAPY DEVICE (K800565)Hessler Mfg. Co.1980-06-26
PROXIMATE (TMD) TISSUE MEASURING DEVICE (K801374)ETHICON, Inc.1980-06-26
ORTHOPEDIC LOWER EXTREMITY SUSPENSION (K801436)Orthopedic Systems, Inc.1980-06-26
MEDTRONIC MODELS 5966/5967, ETC. (K800069)Medtronic Vascular1980-06-26
COBAS REAGENTS FOR URIC ACID (K801243)Roche Analytical Instruments, Inc.1980-06-26
V.I.B.E. VIDEO INTERFACE BIOFEEDBACK EQU (K801049)Nebulae Productions1980-06-26
CAMBRIDGE CARDIAC DIAGNOSTIC SYSTEM (K801224)Cambridge Instruments, Inc.1980-06-26
ANSPACH OPERATING TABLE SUPPORT/SPINAL (K801326)The Anspach Effort, Inc.1980-06-26
SILASTIC BRAND PERCUTANEOUS SKIN EXPANDE (K801042)Dow Corning Corp. Healthcare Industries Materials1980-06-26
D300 DOME (K801136)Gics Pharmaceuticals1980-06-20
MODEL 336B HEARING AID (K801367)Communications, Inc.1980-06-20
AMPCO SKIN SCRUB TRAYS (K801332)Associated Medical Products Co.1980-06-20
EMIT VALPROIC ACID ASSAY (K801207)Syva Co.1980-06-20
STANBIO ACETAMINOPHEN TEST SET #0850 (K801014)Stanbio Laboratory1980-06-20
THE MAGTEC SYSTEM (K801310)Valley Forge Scientific Corp.1980-06-20
COBAS REAGENT FOR AST (SGOT) (K801118)Roche Analytical Instruments, Inc.1980-06-20
URINARY CATHETER SAMPLING KIT (K800946)Sage Products, Inc.1980-06-20
COBAS REAGENT FOR ALKALINE PHOSPHATASE (K801242)Roche Analytical Instruments, Inc.1980-06-20
REIGNING ARTIFICIAL TEETH/POLYCARB.RESIN (K801235)Oki Shiks USA , Ltd.1980-06-20
B-D FILTER NEEDLE (K801343)Bd Becton Dickinson Vacutainer Systems Preanalytic1980-06-20
DUPONT PREP APPLI. FOR PHENOBARBITAL, (K801276)E.I. Dupont DE Nemours & Co., Inc.1980-06-20
GOLDEN THERMAL RHINOPLASTY CAST BANDAGE (K801301)Auric, Inc.1980-06-20
NUCLEAR ENTERPRISES 1612 MULTI-WELL (K801263)Nuclear Ent. , Ltd.1980-06-20
RITTER STERILIZER (K801309)Sybron Corp.1980-06-20
DIGOXIN RADIOIMMUNOASSAY KIT (K801202)Technia Diagnostics , Ltd.1980-06-20
ATOMLIGHT (LIQUID SCINTILLATION SOLUTION (K801245)New England Nuclear1980-06-20
LINEBERGER EXTERNAL MALE CATHETER (K800890)Lineberger External Catheter Co.1980-06-20
SURGICAL INSTRUMENTS (K801292)William Skidmore & Co., Ltd.1980-06-20
FIAX TEST KIT FOR TOBRAMYCIN QUANTITA (K801308)Intl. Diagnostic Technology1980-06-20
MACRO-VUE RUBELLA CARD TEST (K800797)Bd Becton Dickinson Vacutainer Systems Preanalytic1980-06-20
J.T. BAKER IMMUNOGLOBULIN G NEPHELOMETRI (K801281)J.T. Baker Chemical Co.1980-06-20
PROXIMATE*(ILS) DISP. INTRALUMINAL STAP. (K801154)ETHICON, Inc.1980-06-20
ROCHE HCG STANDARDS (K801244)Hoffmann-La Roche, Inc.1980-06-20
TRIGLYCERIDES FOR SMA AND AAII (K801226)Reagents Applications, Inc.1980-06-20
STREPTO-SEC TM (K801159)Organon, Inc.1980-06-20
A-GENT THYROZYME UPTAKE INHIBITOR ASSAY (K800911)Abbott Laboratories1980-06-20
E-VAX CHEST DRAINAGE SYSTEM (K801043)Cardio Surgical Concepts, Inc.1980-06-20
BIOSTATOR PRINTER/PLOTTER (K801210)Miles Laboratories, Inc.1980-06-17
TECNOL QUICK RELEASE LIMB HOLDER (K801272)Tecnol New Jersey Wound Care, Inc.1980-06-17
CLEAR PLASTIC CONNECTING TUBES (K800879)Harvard Laboratories1980-06-17
STRAITH NASAL SPLINT (K801072)Surgical Technology Laboratories, Inc.1980-06-17
COBAS REAGENT FOR BUN (K801116)Roche Analytical Instruments, Inc.1980-06-17
CENTRIFICHEM HDL CHOLESTEROL (K801133)Union Carbide Corp.1980-06-17
DEN-MAT POLISHING PASTE (K801225)Den-Mat Corp.1980-06-17
3M STEAM STERILIZATION INDICATOR (K801057)3M Company1980-06-17
ANALOR FOUR-ORAL SURGERY MODEL (K801101)Narco Mckesson Co.1980-06-17
ACOUSTIC IMPEDANCE METER, MODEL TA-4D (K801293)Teledyne Avionics Div. of Teledyne1980-06-17
STRAITH NASAL IMPLANT (K801074)Surgical Technology Laboratories, Inc.1980-06-17
EMIT VALPROIC ACID CONTROL (K801206)Syva Co.1980-06-17
BURRON MULTI-AD SYRINGE CAP (K801311)Burron Medical Products, Inc.1980-06-17
MEDEFIZZ A & MEDEFIZZ B (K800843)Medefield Pty. , Ltd.1980-06-17
NYLON LIGATING CLIP (K801124)ETHICON, Inc.1980-06-17
THE PROTECTORS (K801312)Cooper Medical Devices Corp.1980-06-17
MEDEFOAM-2 (K800840)Medefield Pty. , Ltd.1980-06-17
TANIT COMMERCIAL SUNTAN BOOTH (K801017)Tanit, Inc.1980-06-17
CAMLOC SYRINGE BIOPSY KIT (K801304)Johannah Medical Services, Inc.1980-06-17
COMPALOR-ORAL SURGERY MODEL (K801102)Narco Mckesson Co.1980-06-17
F.R.C. APPARATUS (K801088)Hogan/Cologne Ent.1980-06-17
HYDRA TRED DC (K801250)Medichanics, Inc.1980-06-17
SECONDARY I.V. TUBING SETS (K800878)Harvard Laboratories1980-06-17
SOLARIUM, MODEL 6040A (K800366)Blendette Intl. , Ltd.1980-06-17
AO STYLET LARYNGOSCOPE MODEL SLS (K801364)American Optical Corp.1980-06-17
HEARING AID, UNITRON MODEL C4-55 (K801230)Unitron Industries, Inc.1980-06-17
ANESTHESIA EXTENSION TUBES (K800877)Harvard Laboratories1980-06-17
CO2 CYSTOSCOPY/URETHROSCOPY CONSOLE (K800822)Kli1980-06-17
ULTRA-CHEK PACEMAKER MONITOR (K801022)Powers Medical Systmes1980-06-17
BRONZAGE TANNING SYSTEM (K800845)Bronzage Rapide1980-06-17
JACKSON LACRIMAL INTUBATION SET (K801232)Storz Instrument Co.1980-06-17
ECA CREAM REFORMULATION (K801383)Vanaray Laboratories, Inc.1980-06-17
SPAC T3 RIA TEST KIT (K801125)Mallinckrodt Critical Care1980-06-09
REIGNING CROWN-BRIDGE/POLYCARB. RESIN (K801237)Oki Shiks USA , Ltd.1980-06-09
ETHOX/BARRON FOOD PUMP GAVAGE BAG SETS (K801144)Ethox Corp.1980-06-09
PENTEX FEXIBLE COLONSCOPE, MOD. FC-34A (K801223)Pentax Precision Instrument Corp.1980-06-09
TRIIODOTHYRONINE RADIOIMMUN. SYSTEM (K801123)Calbiochem-Behring Corp.1980-06-09
REIGNING DENTURE MADE OF POLYCARB. RESIN (K801234)Oki Shiks USA , Ltd.1980-06-09
DISPOSABLE COUPLING ADAPTOR (K801261)Intec Medical, Inc.1980-06-09
EMIT DISOPYRAMIDE CONTROL (K801205)Syva Co.1980-06-09
SMI MULTI-TUBE VORTEXER (K801145)Scientific Manufacturing Industries1980-06-09
BUN-COLOR 2, BLOOD UREA NITROGEN TEST (K800902)Sclavo, Inc.1980-06-09
J.T. BAKER LSA 290 PIPETTER/DILUTER (K801090)J.T. Baker Chemical Co.1980-06-09
CONPHAR CHECKMATE SPHYGMOMANOMETER (K801187)Conphar, Inc.1980-06-09
PERKIN ELMER MODEL 91 AMYLASE REAGENT (K801096)Stat Engineering1980-06-09
ANSPACH INSTRUMENT CADDY (K801329)The Anspach Effort, Inc.1980-06-09
EMIT DISOPYRAMIDE ASSAY (K801204)Syva Co.1980-06-09
S.S. WHITE-PENNWALT PRELUDE PIT SEALANT (K801274)Pennwalt Corp.1980-06-09
HEMOGASTAT (K801148)Therapac, Inc.1980-06-09
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Track 1980 automatically

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