Atlas FDA

1980

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

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RecordFirmDate
DIALYSIS CONTROL UNIT-CENTRY 2000 (K802250)Cobe Laboratories, Inc.1980-12-10
BIOLOGICAL INDICATOR - KEMMED & BIOSURE (K802228)Kem Medical Products Corp.1980-12-09
CHEMICAL INDICATOR - KEM MED & BIO SURE (K802229)Kem Medical Products Corp.1980-12-09
BIOLUMIN. SCREENING FOR BACT. BY ATP A. (K803077)Technology, Inc.1980-12-05
GENERATOR, HIGH VOLT, X-RAY, DIAG. MPX80 (K802548)General Electric Co.1980-12-02
PHADEBAS RAST TEST (K802556)Pharmacia, Inc.1980-12-02
GENERATOR, HIGH VOLT, X-RAY, MPX 100 (K802549)General Electric Co.1980-12-02
GENERATOR, HIGH VOLT, X-RAY, MPX 125 (K802550)General Electric Co.1980-12-02
GENERATOR, HIGH VOLT, X-RAY, MPX100/125 (K802551)General Electric Co.1980-12-02
VON WILLEBRAND FACTOR ASSAY (K802356)Bio/Data Corp.1980-12-01
TRAVENOL ULTRASONIC NEBULIZER CUPS (K802054)Travenol Laboratories, S.A.1980-12-01
SIEMENS-ELEMA PULSE GENERATOR 668 (K801324)Siemens Elema AB1980-12-01
INTERMEDICS' LIFELINE TLE ENDOCARDIAL (K801172)Intermedics, Inc.1980-12-01
LOW PROFILE LEAD CONNECTOR MODIFICATION (4002) (K801284)Medtronic Vascular1980-12-01
MS-2 IDENTIFICATION SYSTEM (K802309)Abbott Laboratories1980-12-01
TENSMATE EMPIMODEL 9980 (K802507)Empi1980-12-01
SOLAR TONE (K802304)Bloomex International, Inc.1980-12-01
GLYCO-TROL HUMAN GLYCOSYLATED HOM. CONT. (K802432)Clin Tech Diagnostics Corp.1980-12-01
GRISTINA GLENOID PROSTHESIS (K802124)Howmedica Corp.1980-12-01
T/K (ATA/AMA) UNIVERSAL BIOPAK (K802308)Bioware Products1980-12-01
SINVISION 2001 ULTRASOUND SCANNER (K802484)National Ultrasound Corp.1980-12-01
AUXILIARY TRAY (K802088)American Pharmaseal Div. Ahsc1980-11-28
PDS THERMAL DILUTION CARDIAC MODULE(OUT) (K802316)General Electric Co.1980-11-26
PERICARDIOCENTESIS KIT (K802289)Stanco Medical, Inc.1980-11-26
CONTIUOUS WAVE DOPPLER ULTRASOUND (K802670)American Edwards Laboratories1980-11-26
ENTERMED ENTUNIT (K802712)Jedmed Instrument Co.1980-11-26
RESPIRGARD (K802763)Marquest Medical Products, Inc.1980-11-26
GENERAL ULTRASOUND EXAM. TABLE (K802254)Engineering Dynamics Corp.1980-11-26
MODEL 4700A ELECTROCARDIOGRAPH (K802718)Hewlett-Packard Co.1980-11-26
SPECIAL PROCEDURE AQAROSE FILM (K802395)Electrophoresis Corp.1980-11-26
A2 IMAGE PROCESSING SYSTEM (K802475)Medtronic Vascular1980-11-26
HP MODEL 8880A FILTER (K802686)Hewlett-Packard Co.1980-11-26
GENERAL PROCEDURE AGAROSE FILM (K802396)Electrophoresis Corp. of America1980-11-26
TECA MODEL-10 ELECTROMYOGRAPH (K802637)Teca, Inc.1980-11-26
MODEL T-6 EEG TELEPHONE TRANSMITTER (K802656)Telediagnostic Systems, Inc.1980-11-26
UCA CREAM PRODUCT REFORMULATION (K802648)Vanaray Laboratories, Inc.1980-11-26
RIONET HEARING AID (K802812)Kindel & Anderson1980-11-26
COBE/STOCKERT BATTERY MODULE (K802714)Cobe Laboratories, Inc.1980-11-26
CHEMISTRY ANALYZER IMPACT 400 (K802609)Gilford Instrument Laboratories, Inc.1980-11-26
BIOMETRIC ERG SYSTEM (K802472)Biometric Analysis Group, Inc.1980-11-26
CAFFEINE REAGENT DIAZO COLORIMETRY (K802630)American Monitor Corp.1980-11-26
NORMOCAP CR-102, RECORDER UNIT (K802762)Instrumentarium-Datex1980-11-26
APTEK ULTRASOUND PROCEDURE TRAY (K802666)Aptek , Ltd.1980-11-26
ARTERIOVENOUS BLOOD TUBING SETS (K802874)Extracorporeal Medical Specialities, Inc.1980-11-25
CELLAMIN (K802796)Secol Co.1980-11-24
NARCO AIR-SHEILDS SYS. 100 MONITOR SYS (K802800)Narco Air-Shields1980-11-24
KETAC-CEM IN REF. TO K802048 (K802819)Espe Dental Products1980-11-24
ANSWER AT-HOME PREGNANCY TEST KIT (K802660)Armkel, LLC1980-11-24
ROBERTSON OBTURATION MONITOR INSUFFLA (K802374)Endotek Corp.1980-11-24
SERUM T4 BY ENZYME IMMUNOASSAY (K802573)Worthington Diagnostic Systems1980-11-24
PLASTIC ADHESIVE BANDAGE (K802764)Dyn-A-Med Products1980-11-24
HELIOMAT (K802684)Vivadent (Usa), Inc.1980-11-24
MONOJECT ROOT CANAL FILLING MAT. NEEDLE (K802811)Sherwood Medical Co.1980-11-24
CYBREX TOBRAMYCIN (K802668)Abbott Laboratories1980-11-24
CONTACT SEAL (K802682)Vivadent (Usa), Inc.1980-11-24
IN VITRO DIAGNOSTIC STANDARDS (K802278)Supelco, Inc.1980-11-24
HELIOSIT (K802683)Vivadent (Usa), Inc.1980-11-24
CARDIOACTIVE DRUGS CONTROL (K802672)Fisher Scientific Co., LLC1980-11-24
MEDIUM SIZE OXYGEN HOOD #1547 (K802653)Ann Arbor Plastics, Inc.1980-11-24
HELIOBOND (K802681)Vivadent (Usa), Inc.1980-11-24
VITAMIN B12 FOLATE RADIOASSAY (K802037)Corning Medical & Scientific1980-11-21
RIGHT ATRIAL LINE KIT (K802287)Stanco Medical, Inc.1980-11-20
SWAN GANZ CATHETER PLACEMENT KIT (K802288)Stanco Medical, Inc.1980-11-20
EXTENDED BALLJOINT GRIP (K802723)Howmedica Corp.1980-11-19
CARBIDE CUTTING INSTRUMENT/INTRAARTICU (K802598)The Anspach Effort, Inc.1980-11-19
TERPERATUR SENSING DEVICE (K802607)Burditt & Calkins-Siemens-Elema1980-11-19
FMS-02 FLOOR-UNIT MODEL MICROSCOPE (K802713)Jedmed Instrument Co.1980-11-19
MICROLET FAMILY OF NEEDLE/DEPTH ELECT- (K802249)Progress Mankind Technology1980-11-19
PMT DEPTHALON DEPTH #2102 (K802152)Progress Mankind Technology1980-11-19
FOLDING ROLL-ABOUT CHAIR (K802744)Winco Winfield Co., Inc.1980-11-19
PMT DEPTHALON DEPTH CORTICOGRAPHY ELEC (K802151)Progress Mankind Technology1980-11-19
SAVE MOR (K801945)Cardia Concepts Corp.1980-11-19
INSTRUMENTS NONSTERILE & STERILE (K802726)Ascep, Inc.1980-11-19
CONVALESCENT RECLINER (K802803)Winfield Co., Inc.1980-11-19
MAPPING PROBE MODEL #6540 (K802058)Cardiac Pacemakers, Inc.1980-11-19
LATEX PENROSE TUBING CAT. #20400,414,416 (K802761)American Hospital Supply Corp.1980-11-19
ENDOTRACHEAL TUBE HOLDER (K802675)Respiratory Support Products, Inc.1980-11-19
HELFET ELBOW PROSTHESIS (K802460)Depuy, Inc.1980-11-19
THE CRITERION II PACING SYS. MONITOR (K802782)Dart Medical Equipment1980-11-19
CARDIACINDEX COMPUTER MODEL SP 1435 (K802476)Gould, Inc.1980-11-19
CPR TRAVELER (K801947)Cardia Concepts Corp.1980-11-19
HOFFMAN LEG LENGTHENING DEVICE (K802776)Howmedica Corp.1980-11-19
EXTERNAL FIXATION SYSTEM (K802722)Howmedica Corp.1980-11-19
CHRONOCOR IV MODEL 250 (K802221)Cordis Corp.1980-11-19
CPR HELPER (K801946)Cardia Concepts Corp.1980-11-19
MODEL 3003 UNIPOLAR DEMAND CARDIAC GEN. (K802588)Arco Medical Products Co.1980-11-19
FOLDING SHOWER-COMMODE CHAIR (K802745)Winco Winfield Co., Inc.1980-11-19
LITHICRON 0520 P-SYNCHRONEOUS PULSE GEN. (K792609)Medcor, Inc.1980-11-19
REIGNING DENTURE (K802490)Oki Shiks USA , Ltd.1980-11-19
CAVITRON ULTRASONIC SURG. ASPIR. CUSA (K801623)Cavitron Corp.1980-11-18
IC-2 VENTILATOR (K801890)Bio-Med Devices, Inc.1980-11-18
SHARPS CADDY MAGNETIC & SHARPS CADDY FOA (K802866)Instranetics, Inc.1980-11-17
A.M.P.C.O. SKIN SCRUB TRAY (K802570)Associated Medical Products Co.1980-11-14
SILENTSLEEP (K801927)Slumber Research, Inc.1980-11-14
MEDTRONIC MODEL 6958 (K800870)Medtronic Vascular1980-11-13
WORRELL PATELLA FEMORAL SHIELD (K801934)Depuy, Inc.1980-11-13
SPONGE SURGICAL GUAZE RADIOPAQUE (K802504)Barnhardt Mfg. Co.1980-11-12
TOUCHLESS CLEAN-CATH (K802665)Diamed Division Ill. Tool Works, Inc.1980-11-12
T4 RADIOIMMUNOASSAY KIT (K802469)American Diagnostic Corp.1980-11-12
GAS GENERATING KIT SYSTEM FOR CAMPYLOB. (K802494)Oxoid U.S.A., Inc.1980-11-12
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Every clearance here is in the API, with alerts when new ones post.