Atlas FDA

1987

4,160 FDA 510(k) clearances · Clearance year

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RecordFirmDate
DAHLBERG MODEL UL IN-THE-EAR HEARING AID (K871525)Dahlberg Electronics, Inc.1987-05-19
MCCONNELL ORTHOPEDIC STERILE UPRIGHT SUPPORT (K871805)Mcconnell Orthopedic1987-05-19
MCCONNEL ORTHOPEDIC ARTHROSCOPY SUPPORT ASSEMBLY (K871804)Mcconnell Orthopedic1987-05-19
HR-5000 ELECTROSURGICAL DEVICE (K864869)Ime Co. , Ltd.1987-05-19
LUTEMOLL (BIOPLAST) (K871038)B. L. Dental Co.1987-05-19
BABYSET(TM) MODIFIED JACKSON-REES CIRCUIT W/VALVE (K871669)Life Design Systems, Inc.1987-05-19
MODEL 20-C WITH AN SA-20B/U OPT. ATTACH. HEMORRHO. (K871029)Directed Energy, Inc.1987-05-18
TANNE CORNEAL CUTTING BLOCK (K871646)Ocular Instruments, Inc.1987-05-18
ORMCO GEL-ETCH (K871591)Scientific Pharmaceuticals, Inc.1987-05-18
ALLERGAN HUMPHREY AUTO-REFRACTOR, MODELS 525 & 540 (K871611)Allergan Humphrey1987-05-18
KIRSCHNER MODULAR HIP SYSTEM (K871401)Kirschner Medical Corp.1987-05-18
OPTHA PREP (K871706)Treace Medical, Inc.1987-05-18
REAGENTS 1263,1273,1284,1425,014301,053583 (K871531)American Research Products Co.1987-05-18
MODIFIED USE OF PULL-APART INTRODUCER SET (K871730)Quinton, Inc.1987-05-18
CYCLO-BRUSH (K870782)Medline Industries, Inc.1987-05-18
TOPCON COMPUTERIZED TONOMETER CT-10 (K871335)Topcon Instrument Corporation of America1987-05-18
DENTAL DIAMOND BURS (K871639)E&D Dental Manufacturing Co.1987-05-18
ANESTHASSIST (K871564)Anestech, Inc.1987-05-18
MODEL 20-C WITH AN SA-20A/U OPT. ATTACH. HEMORRHO. (K871032)Directed Energy, Inc.1987-05-18
ENZYMATIC CHOLESTEROL REAGENT SET (K871676)Michclone Associates, Inc.1987-05-18
EMED-F-SYSTEM (K871690)Novel GmbH1987-05-15
MODEL 10-C WITH AN SA-10A/U OPT. ATTACH. HEMORRHO. (K871030)Directed Energy, Inc.1987-05-15
TICARCILLIN/CLVULINIC ACID 85 MCG SUSCEPTIBILITY D (K871674)Organon Teknika Corp.1987-05-15
10-C/SA-10B/U OPT 20-C/20A/U BEAM SA-10B/U HEMORRH (K871031)Directed Energy, Inc.1987-05-15
PRECINORM(R) PROTEIN (K871027)Boehringer Mannheim Corp.1987-05-15
CELL LIFTER (K871559)Corning Costar Corp.1987-05-15
KALLESTAD QM300 PROTEIN ANALYSIS SYSTEM (K871339)Kallestad Diag, A Div. of Erbamont, Inc.1987-05-15
GAMBRO POLYFLUX 130 AND 160 HEMODIALYZER (K871108)Gambro, Inc.1987-05-15
DRIPRIDE DISPOSABLE UNDERPADS (K871725)Weyerhaeuser Co.1987-05-15
SPOTTEST FLAGELLA STAIN (K871606)Difco Laboratories, Inc.1987-05-15
GASTROTOPO (K861291)Houston Biomedical, Inc.1987-05-15
THE SPIRA ELEKTRO 2 (K871151)Warren E. Collins, Inc.1987-05-15
I-125 ANTI-THYROGLOBULIN ANTIBODY IRMA TEST KIT (K871193)Cronus1987-05-15
QM2/QM300 BUFFER AND DILUENT PACK (K871343)Kallestad Diag, A Div. of Erbamont, Inc.1987-05-15
AEROSOL ONE, NEBULIZER PUMP (K870428)Ashai Co. , Ltd.1987-05-15
ANAEROBIC TRANSPORT POUCH (CATALYST-FREE) (K871709)Difco Laboratories, Inc.1987-05-15
PRECIMAT(R) C3 (K871024)Boehringer Mannheim Corp.1987-05-15
CURITY CONTINUOUS EPIDURAL ANESTHESIA TRAY (K871066)The Kendal Co.1987-05-15
EFER ARTHROSCOPE (K870654)Roseburg SA1987-05-14
PENTAMAX 1 MODEL B TABLE SYSTEM (K870707)Spectrum X-Ray Corp.1987-05-14
CIBA CORNING MAGIC(R) LITE T4 IMMUNOASSAY (K870965)Ciba Corning Diagnostics Corp.1987-05-14
PRECIMAT(R) TRANSFERRIN (K871022)Boehringer Mannheim Corp.1987-05-14
VISION (TM) HDL CHOLESTEROL (K871461)Abbott Laboratories1987-05-14
TOTAL BILIRUBIN REAGENT 1372,1425,1284,1273,053583 (K871530)American Research Products Co.1987-05-14
MEDTRONIC MODEL 4220 AMBULATORY ECG MONITOR (K870652)Medtronic Vascular1987-05-14
HPROLACTIN KIT (K871542)Immuchem Corp.1987-05-14
H-H HARRIS NEONATAL NASAL CANNULA SET FOR CPAP (K871351)Holter-Hausner Intl.1987-05-14
BADGWELL SAMPLING CATHETER (K870858)Dryden Corp.1987-05-14
PRECIMAT(R) C4 (K871023)Boehringer Mannheim Corp.1987-05-14
SIEMENS MAIN FLOW BACTERIA FILTER (K871366)Siemens Elema AB1987-05-14
SMILJANIC BONE REPOSITIONING FORCEPS (K871535)Link America, Inc.1987-05-14
IMMUSTRIP(TM) DSDNA ELISA TEST SYSTEM (K870903)Immunomedics, Inc.1987-05-14
SIMPSON PERIPHERAL ATHEROCATH(TM) (K871011)Devices For Vascular Intervention, Inc.1987-05-14
WESTERN RAGWEED ALLERGEN DISC (K871660)Incstar Corp.1987-05-14
JOHNSON INTRATRACHEAL OXYGEN CATHETER SET (K870181)Cook, Inc.1987-05-14
X-CEL X-RAY MODELS ORT90W, ORT90M AND ORT90R (K871116)X-Cel X-Ray Corp.1987-05-14
HARTFORD TOTAL HIP SYSTEM (TRI-WEDGE) (K870128)Richards Medical Co., Inc.1987-05-13
ALKALINE PEPTONE WATER (K871640)Bd Becton Dickinson Vacutainer Systems Preanalytic1987-05-13
ABBOTT A-GENT LD-1 ISOZYME REAGENT (K871240)Abbott Laboratories1987-05-13
BUFFALO GREEN MONKEY KIDNEY CELLS (K871613)Viromed Laboratories, Inc.1987-05-13
TODD HEWITT W/CNA (LIM BROTH) (K871447)Remel Co.1987-05-13
THE GONOGEN II TEST KIT FOR NEISSERIA GONORRHOEAE (K871105)New Horizons Diagnostics Co.1987-05-13
CREATINE KINASE FOR CONTINUOUS FLOW INSTRUMENTS (K871677)Catachem, Inc.1987-05-12
HEARTSTART 2000, MANUAL DEFIBRILLATOR (K871136)First Medical Devices Corp.1987-05-12
AVL MODEL 985 ELECTROLYTE ANALYZER (K870657)Avl Scientific Corp.1987-05-12
40CC PERCUTANEOUS FURL DOU. LUMEN BALLOON CATHETER (K864567)Aries Medical, Inc.1987-05-12
KODAK EKTACHEM DT SLIDES (CA) (K870035)Eastman Kodak Company1987-05-12
40CC SURGICAL DOUBLE LUMEN BALLOON CATHETER (K864568)Aries Medical, Inc.1987-05-12
PCTE MICROPOROUS MEMBRANE FILTER (K870196)Poretics Corp.1987-05-12
DELFIA (TM) HTSH KIT (K871644)Lkb Instruments, Inc.1987-05-12
EASY-TEST EMIT GENTAMICIN (GENT) ITEM NO. 16640 (K871329)Em Diagnostic Systems, Inc.1987-05-12
COLORIMETRIC BUN REAGENT KIT (K871651)Biochemical Trade, Inc.1987-05-12
CONTACT LENS TWEEZERS (K871130)S. M. C. Medi-Tech Corp.1987-05-12
TAMPAX TAMPON, REGULAR (K871642)Tambrands, Inc.1987-05-12
HEARTSTART 2000, MANUAL MEDICAL CONTROL MODULE (K871135)First Medical Devices Corp.1987-05-12
DSP100 CAROTID PHONOANGIOGRAPHY MODULE (K864429)Intl. Acoustics, Inc.1987-05-12
T.O.P. 2000 (TOMOGRAPHIC ORIENTATED PLANNING) (K870221)Kermath Mfg. Corp.1987-05-12
IONOMETER EF AND ACCESSORIES (K870183)Smash Ent., Inc.1987-05-12
CONTOUR SOFT-E SERIES CONDUCTIVE SOLID GEL ELECTRO (K871412)Contour Electrodes, Inc.1987-05-12
GLUCOSE ENZYME - COLOR REAGENT SET (K871650)Biochemical Trade, Inc.1987-05-12
NEY-ORO 41 (K870677)Deringer-Ney, Inc.1987-05-12
EASY-TEST CHEM CAL LEVELS 1,2&3/ITEMS 67617 ABC/95 (K871638)Em Diagnostic Systems, Inc.1987-05-12
ACU-PREG-AL SLIDE TEST (K871294)Papibris Scientific, Inc.1987-05-12
PLAYTEX TAMPONS AND DEODORANT TAMPONS (K871197)Intl. Playtex, Inc.1987-05-12
BARD EMS SYSTEM 6000 E.S.U. (K871435)C.R. Bard, Inc.1987-05-11
RAPIDEX BIOLOGICAL SURFACTANT (K862282)Rapidex of London1987-05-11
THERMOMETER SHEATHS (K871465)Abco Dealers, Inc.1987-05-11
RECORD KEEPING/DATA MANAGEMENT SYSTEM (K865035)Critical Care Systems, Inc.1987-05-11
IVR-SP CUSTOM ANGIOGRAPHY TRAY (K870419)North Coast Medi-Tek1987-05-11
OMEGA SILICONE CHIN IMPLANT (K871070)Omega Silicone, Inc.1987-05-11
SINGLE LUMEN ACUTE CATHETER (K870328)Quinton, Inc.1987-05-11
CARDIAC PERFORMANCE MONITOR (K864583)Vascular Technology Incorporated1987-05-11
APPLICARD SYSTEM (ECG ELECTRODE SYSTEM) (K864260)Grandcor Medical Systems1987-05-11
OMEGA BIVALVE NASAL SPLINTS (K871073)Omega Silicone, Inc.1987-05-11
GASTROINTESTINAL TUBE (K870508)Penn Medical Devices, Inc.1987-05-11
3MHZ ANNULAR ARRAY (K864980)Philips Ultrasound, Inc.1987-05-11
SOLOLIFT - PATIENT TRANSFER STRETCHER (K871475)Adel Medical , Ltd.1987-05-11
RESUBMITTED TRIGLYCERIDE GPO - TWO VIAL (K871508)Trace Scientific , Ltd.1987-05-08
FNA THYROID BIOPSY KIT (K870863)Flint Laboratories Div. Travenol1987-05-08
BANDAGES CATALOG NUMBER: 101 TO 220 (K871495)I M, Inc.1987-05-08
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Track 1987 automatically

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