Atlas FDA

1980

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

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RecordFirmDate
FTA-ABS BIOPAK (K802276)Bioware Products1980-10-23
VERTIX 3D-U (K802200)Siemens Corp.1980-10-23
VIEW-LITE, MODEL-SL (K802217)Med-Western Electronics, Inc.1980-10-23
SP 120 SOPHISTICATE (K802251)Vickers America Medical Corp.1980-10-23
E.R.C.P. CANNULA PRODUCT (K802443)Mill-Rose Laboratory1980-10-23
E-VAC BLOOD CULTURE SYSTEM (K802408)Pfizer Pharmaceuticals1980-10-23
UCG-BETA SLIDE (K802435)Armkel, LLC1980-10-23
URIC ACID/ALDH (K802371)Boehringer Mannheim Corp.1980-10-23
SIEMENS-ELEMA AB CO2 MONITOR 130 (K802459)Siemens Elema AB1980-10-23
TRUE SPECTRUM ANALYSIS/MARK IV DUPLEX (K801972)Advanced Technology Laboratories, Inc.1980-10-23
ARROW CATHETER CLAMP (K802367)Arrow Intl., Inc.1980-10-23
AMX-III (K802047)General Electric Co.1980-10-23
DEHYDROEPIANDROSTERONE SULFATE KIT RIA (K802195)Radioassay Systems Laboratories, Inc.1980-10-23
TENCKHOFF CATHETER (K801818)Sil-Med Corp.1980-10-23
COMBOSTAT - NO-BOIL KIT (K801578)Ria Products, Inc.1980-10-23
ARGLE LATEX PENROSE TUBING (K802286)Sherwood Medical Co.1980-10-23
IMED DROP RATE CALCULATOR #340 (K801734)Imed Corp.1980-10-23
SERUM SEPARATOR (K802211)Scientific Specialties, Inc.1980-10-23
ANALYTE T3 UPTAKE (K802246)Technicon Instruments Corp.1980-10-23
G.E. SCAN CAPABILITY CAT.#B7815F (K802045)General Electric Co.1980-10-23
IN-LINE SCAN HEAD MODIFICATION MARK III (K801971)Advanced Technology Laboratories, Inc.1980-10-23
SD-900 OSCILLOMETRIC BP MONITOR (K802218)Industrial & Biomedical Sensors Corp.1980-10-23
UNIPOLAR TO BIPOLAR PULSE GEN. ADAPTER (K802077)Cardiac Pacemakers, Inc.1980-10-23
ATTENU-CHEK (K802350)Hear Co., Inc.1980-10-23
IMPLANTABLE ENDOCARDIAL POROUS TIP ELEC. (K801792)Telectronics, Inc.1980-10-23
ANTISERA TO HUMAN FREE LAMBDA LIGHT CH. (K802284)Kallestad Laboratories, Inc.1980-10-23
TRIGLYCERIDES DETERMINATION (K802256)Coleman Laboratories Corp.1980-10-23
VITAMIN B12 - NO-BOIL KIT (K801579)Ria Products, Inc.1980-10-23
FTA-ABS TEST (K801959)Immuno-Diagnostic Products, Inc.1980-10-23
PHENYTOIN REAGENT TEST KIT (K802038)Beckman Instruments, Inc.1980-10-23
ANTISERA TO HUMAN FREE KAPPA CHAINS (K802283)Kallestad Laboratories, Inc.1980-10-23
ASTRA PRINTER PAPER #88112-CHLORIDE SILV (K802392)Hi Chem, Inc.1980-10-23
PACEPATH MODEL 819 (K801417)Pacesetter Systems1980-10-23
NEBULIZER, MEDICINAL (K802430)Dhd Medical Products Div. Diemolding Corp.1980-10-23
PHENOBARBITAL REAGENT TEST KIT (K802039)Beckman Instruments, Inc.1980-10-23
SURETY COLUMN (K802209)Scientific Specialties, Inc.1980-10-23
OMNI SCANNER CT 6000 (K802206)Omnimedical1980-10-23
U.I. OCTOSON (K801675)Ausonics Pty , Ltd.1980-10-23
ENDAB THEOPHYLLINE ENZYME IMMUNOASSAY (K802066)Immunotech Corp.1980-10-23
EXTERNAL, TEMP. PORTABLE CARDIAC GENER (K801953)Telectronics, Inc.1980-10-23
LEAD, ENDOCARDIAL, TINED, BIPOLAR, 5MM (K801455)Pacesetter Systems1980-10-23
JK INT'L, INC. SOLTRON UVA TANNING BED (K802134)Mottek Intl. Corp.1980-10-23
RESPO2 OXYGEN CONCENTRATOR (K802426)Mada Medical Products, Inc.1980-10-23
CORDIS DOW INFUSION PUMP (K802301)Cordis Corp.1980-10-23
UMBILI-CATH CATHETER (K802414)Int'L Corp.1980-10-23
THE IMMOBILIZER FOR OPEN & ARTHROSCOPIC (K802271)The Anspach Effort, Inc.1980-10-23
DAHLBERG HEARING AID MODEL AI (K802510)Dahlberg Electronics, Inc.1980-10-23
COS-UPHOFF INT'L DS-5 DRAINAGE SYSTEM (K802214)Cox-Uphuff Intl.1980-10-23
MODEL 633A THREE CHANNEL STRESS TEST (K802190)Quinton, Inc.1980-10-23
DIGITAL RADIOGRAPHY SYSTEM (K802150)Adac Laboratories1980-10-23
HGB3 (1:251) (K802266)R&D Systems, Inc.1980-10-23
COTTON ROLLS (K802429)Worldwide Surgical Gauze1980-10-23
PROPPER SHARPGUARD & TRAYPAD STERIL. AID (K802428)Propper Mfg. Co., Inc.1980-10-23
ARGYLE COMPACT CHEST DRAINAGE SYS. (K802440)Sherwood Medical Co.1980-10-23
ARGYLE SILICONE THORACIC CATHETER (K802318)Sherwood Medical Co.1980-10-23
VIEW-LITE, MODEL-DL (K802216)Med-Western Electronics, Inc.1980-10-23
MO8 OXYGEN FLOWMETER (K802311)Timeter Instrument Corp.1980-10-23
TEMP STERNUM SAW (K801914)Temp Medical Products, Inc.1980-10-23
SD-800 BLOOD PRESSURE MONITOR (K802202)Industrial & Biomedical Sensors Corp.1980-10-23
GAMMA COAT(125 I) RUBELLA ANTIBODY (K801667)Clinical Assays, Inc.1980-10-23
VIVONEX JEJUNOSTOMY KIT (K802300)Norwich Eaton Pharmaceuticals, Inc.1980-10-23
KLINAR REAGENT PAK, #36010 (K801892)Hi Chem, Inc.1980-10-23
UNIVERSAL TEMP. PACING ELECT. #080-10000 (K801800)Medical Testing System, Inc.1980-10-23
KODAK EKTA-CHEM CLINICAL CHEM. SLIDES (K802376)Eastman Kodak Company1980-10-23
CORTISOL125 RADIOIMMUNOASSAY (K802036)Corning Medical & Scientific1980-10-23
TRANSVENOUS PACEMAKER ELECTRODE KIT (K802259)Stanco Medical, Inc.1980-10-23
UCG-BETA STAT (K802421)Armkel, LLC1980-10-23
MEDELA ELECTRIC BREAST PUMP (K801862)Medela, Inc.1980-10-23
OHIO RADIANT WARMER (K802365)Ohio Medical Products1980-10-23
SALEM/RESCE INTUBATION GUIDE (K802416)Scientific Sales Intl., Inc.1980-10-23
105MM SPOT FILM CAMERA (K802132)Instrumentation Camera, Inc.1980-10-23
AMPCO SHAVE PREP TRAYS, CAT.#SP4020 (K802041)Associated Medical Products Co.1980-10-23
CMV TEST KIT (K801963)Immuno-Diagnostic Products, Inc.1980-10-23
MODEL 2500 PNEUMATIC PERCUSSOR (K802399)Medical Equipment Development Co., Inc.1980-10-23
SCOTT NEEDLE & SCOTT MICK IMPLANTER (K801983)Mick Radio-Nuclear Instruments, Inc.1980-10-23
SD-700 BLOOD PRESSURE MONITOR (K802201)Industrial & Biomedical Sensors Corp.1980-10-23
VIEW-LITE, MODEL-S (K802215)Med-Western Electronics, Inc.1980-10-23
IL TOTAL PROTEIN REAGENT (K802310)Instrumentation Laboratory CO1980-10-23
ORTHO BOVINE ALBUMIN SOLUTION 30% PROTE (K802404)Ortho Diagnostics, Inc.1980-10-23
MINI MICK APPLICATOR (K802032)Mick Radio-Nuclear Instruments, Inc.1980-10-23
IN-LINE SCAN HEAD MARK IV DUPLEX ULTRA (K801973)Advanced Technology Laboratories, Inc.1980-10-23
AB O2 CONSUMPTION CALCULATOR 980 (K802417)Siemens Elema AB1980-10-23
CRITERION II PACING SYSTEM MONITORS (K802325)Dart Medical Equipment1980-10-23
PAPILLOTOME PRODUCT (K802444)Mill-Rose Laboratory1980-10-23
URINARY CATHETER CARE TRAYS #3700&3710 (K801787)The Healthcare Group Laboratories, Inc.1980-10-21
FOLEY CATHETERIZATION TRAY (K801820)Abco Dealers, Inc.1980-10-21
URETHRAL CATHETERIZATION TRAYS (K801785)The Healthcare Group Laboratories, Inc.1980-10-21
EMIT-STM URINE CONTROLS (K802622)Syva Co.1980-10-20
HEPA-SHURE -L (K802120)Nuclear Medical Laboratories, Inc.1980-10-20
REGIONAL INTRAVENOUS ANESTHESIA KIT (K802290)Stanco Medical, Inc.1980-10-17
FIGURETRIM (K802269)Colne Medical Co. , Ltd.1980-10-13
KEMTROL SERUM CONTROL-NORMAL (K802108)Helena Laboratories1980-10-10
WHITE KNIGHT DRAPE SEAL (K802280)G.D. Searle and Co.1980-10-10
WIDEX HEARING AID #'S A18+T & A18+H (K802306)Hearing Aid Co.1980-10-10
SHEATH DILATOR SET (K802327)Stanco Medical, Inc.1980-10-10
REAGENTS USED-QUAN. MEASURE OF SERUM (K802154)Panmed, Inc.1980-10-10
GLUCOSE DIAGNOSTIC REAGENT (K801897)Connecticut Diagnostics, Ltd.1980-10-10
OP-SITE SKIN CLOSURE SUTURE ADHESIVE (K801884)Acme United Corp.1980-10-10
8-HYDROXYQUINOLINE, CRESOLPHTHALEIN COM. (K802164)Panmed, Inc.1980-10-10
INPERSOL-CAPD ADMINISTRATION SET (K801881)Abbott Laboratories1980-10-10
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Track 1980 automatically

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