Atlas FDA

Cardiovascular

19,134 FDA 510(k) clearances · Medical specialty

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RecordFirmDate
PORTA-FIB LPD (K801544)Narco Bio-Systems1980-07-14
SHILEY CARDIOTOMY RESERVOIR W/FILTER (K801375)Shiley, Inc.1980-07-14
STERILE, DISP DOME, INDIVID. PKG. (K801239)Pacific Domes, Inc.1980-07-14
MODEL P-380 PHYSIOLOGICAL PRESSURE TRAN. (K801138)Gics Pharmaceuticals1980-07-14
ADAPTAID ELEMA LEAD ADAPTER KIT 365-17 (K801038)Intermedics, Inc.1980-07-08
EC-4 PLETHYSMOGRAPH (K801291)D. E. Hokanson, Inc.1980-07-08
MULTICOR (GAMMA) MODEL 336 & MODEL 337 (K801106)Cordis Corp.1980-07-08
ABBY II PATIENT MONITOR OR VITAL SIGNS M (K801515)Abbott Medical Electronics Co.1980-07-08
SERIES 602 CKG RECORDER (MODIFIED) (K801485)Cardio Kinetics, Inc.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
SAPHENOUS VEIN CANNULAE (K801396)Texas Medical Products, Inc.1980-06-30
VASCULAR CLAMP (K801395)Texas Medical Products, Inc.1980-06-30
PERMANENT & TEMP. PACEMAKER ELECTRODE (K800795)Daig Corp.1980-06-30
DISPOSABLE PERFUSION CONNECTORS (K801405)Texas Medical Products, Inc.1980-06-30
UNIPOLAR PROGRAMMABLE LITHIUM CARD. GEN. (K801241)Arco Medical Products Co.1980-06-30
DISPOSABLE SUMP SETS (K801392)Texas Medical Products, 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
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
MICROTHIN-P1 (MOD. 0622) (K801121)Cardiac Pacemakers, Inc.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
CORONARY PERFUSION CONNECTOR PLUG (K801399)Texas Medical Products, Inc.1980-06-30
PROGRAMMABLE BIPOLAR CARDIAC GENERATOR (K800837)Arco Medical Products Co.1980-06-30
MEDTRONIC MODELS 5966/5967, ETC. (K800069)Medtronic Vascular1980-06-26
CAMBRIDGE CARDIAC DIAGNOSTIC SYSTEM (K801224)Cambridge Instruments, Inc.1980-06-26
D300 DOME (K801136)Gics Pharmaceuticals1980-06-20
ULTRA-CHEK PACEMAKER MONITOR (K801022)Powers Medical Systmes1980-06-17
CONPHAR CHECKMATE SPHYGMOMANOMETER (K801187)Conphar, Inc.1980-06-09
CONPHAR DESK TOP MERCURY SPHYGMOMAN (K801188)Conphar, Inc.1980-06-09
CONPHAR DELUXE ANEROID SPHYGMOMANOMETER (K801186)Conphar, Inc.1980-06-09
PEDIATRIC ARTERIAL BLOOD FILTER #AF-5 (K801147)Bentley Laboratories, Inc.1980-06-04
ARCOLITH 3022&ARCOLITH 3023 CARDIAC GEN. (K800838)Arco Medical Products Co.1980-06-04
CONPHAR SPRAGUE RAPPAPORT STETHOSCOPE (K801184)Conphar, Inc.1980-06-04
CONPHAR SUPERTONE STETHOSCOPE (K801189)Conphar, Inc.1980-06-04
BUILT-IN TEMPERATURE MONITORING (K801240)Bentley Laboratories, Inc.1980-06-04
CONPHAR WALL MODEL MERCURY SPHYGMOMAN. (K801182)Conphar, Inc.1980-06-04
CONPHAR BOWLS STETHOSCOPE (K801185)Conphar, Inc.1980-06-04
LIFELINE TLE (TRAEBECULAR LODGING ELEC (K792300)Intermedics, Inc.1980-06-04
ABCO PEDIATRIC STETHOSCOPE (K801215)Abco Dealers, Inc.1980-06-04
SAMPLING MANIFOLD H530 (K801200)C.R. Bard, Inc.1980-06-04
LIFELINE TLE J-SHAPED ATRIAL ENDOCARDIAL (K792301)Intermedics, Inc.1980-06-04
TONOTEST BLOOD PRESSURE MONITOR (K800904)Retlif, Inc.1980-06-04
CONPHAR DUAL HEAD STETHOSCOPE (K801183)Conphar, Inc.1980-06-04
UNICUF, BLOOD PRESSURE CUFF (K801099)Frontier Products1980-05-30
LEAD, TINED PACING, IMPLANTABLE (K800354)Daig Corp.1980-05-30
PERMANENT LEAD INTRADUCER (K800356)Daig Corp.1980-05-28
RESTERILIZATION OF IMPLANTABLE ELECTRODE (K800891)Telectronics, Inc.1980-05-28
ENDOCARD. PACING LEAD STD. LENGTH PL202 (K800350)Daig Corp.1980-05-28
ENDOCARD. PACING LEAD LONG LENGTH PL200 (K800349)Diag Corp.1980-05-28
PACEMAKER, ELECTRODE, PERM. & TEMP. (K800351)Daig Corp.1980-05-28
ANGIO-FLO MONITORING KIT (K801173)Hospital Products Co.1980-05-28
UNIPOLAR LEAD CONFIGURATION CONDUCTOR (K800348)Daig Corp.1980-05-28
LARGE SCREEN CRT DISPLAY #1311B (K801000)Hewlett-Packard Co.1980-05-28
ADAPTER KIT (K800353)Daig Corp.1980-05-28
LEAD, SUTURELESS MYOCARDIAL (K800355)Daig Corp.1980-05-28
AMBULATORY MONITOR AM-1 (K801001)Burdick Corp.1980-05-28
PACE-PULSE/COMPUTRAC (K800782)Bib, Inc.1980-05-28
PERM. INPLANT ENDOCARD. PAC. LEAD (K800347)Daig Corp.1980-05-28
PACEMAKER, ELECTRODE (K800352)Daig Corp.1980-05-28
3M R.F. CURRENT SUPPRESSOR (K801041)3M Company1980-05-23
HYPERSTETHOSCOPE, MODEL Z 00 (K801165)Demonbinder Electronics1980-05-23
R2 APEX-POST.,ANT.&POST. ELECT.(12 MODS) (K800935)R2 Corp.1980-05-23
R2 PADDLE TYPE CABLE-ADAPTOR #S 170,171 (K800936)R2 Corp.1980-05-23
R2(TM) ECG CABLE-ADAPTOR #'S 120-121-122 (K800931)R2 Corp.1980-05-23
ECG-RF-CHOKE CABLE-ADAPTER #'S 121,120 (K800932)R2 Corp.1980-05-23
USCI INTRALUMINAL GRAFT W/DACRON TIE (K801156)C.R. Bard, Inc.1980-05-23
R2 PLATE TYPE CABLE-ADAPTOR #S 175,176 (K800937)R2 Corp.1980-05-23
R2(TM) ECG ELECTRODE SET-#'S305-306 ETC. (K800930)R2 Corp.1980-05-23
MODEL 5985 PACEMAKER PULSE GENERATOR (K800285)Medtronic Vascular1980-05-20
SARNS 7000 MONITOR MODULE (K801097)3M Health Care, Sarns1980-05-20
PRESSURE MONITOR, MODEL 1131B (K801110)American Optical Corp.1980-05-20
PLASTIC TUBING ADAPTERS 5-IN-1- (K800880)Harvard Laboratories1980-05-14
ACCUDYNAMIC (K801048)Sorensen Research1980-05-14
SMEC BALLOON CANNULA (K790755)Smec, Inc.1980-05-14
DISPOSABLE PATIENT CABLE MODEL 5807 (K801064)Daig Corp.1980-05-14
PULSE GENERATORS MODELS 657 & 677 (K800387)Siemens Elema AB1980-05-02
DIGITAL ELECTRONIC B.P. MONITOR 2155 (K800778)Sears, Roebuck & Co.1980-04-29
QUICK FILL (K800823)Medrad, Inc.1980-04-29
EXTENSION LINE (K800622)Norton Performance Plastics Corp.1980-04-29
VENOUS M/A INTERNAL JUGULAR KIT (K800620)Norton Performance Plastics Corp.1980-04-24
SINGLE, 2&3 WAY SOLUTION SETS #14-070 ET (K800618)Norton Performance Plastics Corp.1980-04-24
THERMODILUTION CATHETER INTRO. KIT (K800619)Norton Performance Plastics Corp.1980-04-24
MOD. MCI 17 MANUAL CUFF INFLATOR (K800767)Medasonics, Inc.1980-04-24
FLEXIBLE LINEAR REDUCER F/MITRAL & TRIC. (K800147)Usifroid1980-04-24
MEDI-THERM (K800812)Gaymar Industries, Inc.1980-04-24
SERIES 602 CKGTM RECORDER (K800851)Cardio Kinetics, Inc.1980-04-24
KMA FLOW DIRECTED THERMODILUTION CATHETE (K800836)Kma, Inc.1980-04-24
PERCUTANEOUS CATHETER INTRODUCER ADAPTER (K800621)Norton Performance Plastics Corp.1980-04-24
ECHO-COMP (K800766)Digisonics, Inc.1980-04-24
MODEL 253-11 CYBERLITH PULSE GENERATOR (K800895)Intermedics, Inc.1980-04-24
EPR-200 PROGRAMMER MODEL 010 (K800376)Biotronik Sales, Inc.1980-04-21
NOMOS-01 PULSE GENERATOR (K800375)Biotronik Sales, Inc.1980-04-16
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