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Cardiovascular

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

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RecordFirmDate
APM DISPOS. BLOOD PRESSURE TRANSDUCER (K851888)Honeywell, Inc.1985-08-06
DEFI 2 (K851931)S & W Medico Teknik1985-08-05
SILENT GUARD CAT. NO. SG-30 (K851465)American Omni Medical, Inc.1985-08-05
BARD CRITICAL CARE THERMODILUTIN CATHETER W/INFUSI (K850952)C.R. Bard, Inc.1985-08-05
AJDJUSTABLE SUCTION CONTROL VALVE (K851406)American Omni Medical, Inc.1985-08-05
OCCLUSION & OCCLUSION-IRRIGATION (K844918)Clincal Instruments Corp.1985-08-05
ADVANCED CARDIOVASCULAR SYS LOW PROFILE PTA BALLOO (K851854)Advanced Cardiovascular Systems, Inc.1985-08-05
CARIOLINE(ELECTROCARDIOGRAPH) (K852770)Remco Italia S.P.A.1985-08-01
OMRON DIGITAL BP MONITOR HEM-400C (K851707)Omron Tateisi Electronics Co.1985-07-31
POROCOAT SCHATZKER II ACETABULUM (K852193)Depuy, Inc.1985-07-30
LIFESCOPE 8 DEC-8108A AND DEC-8204A (K852270)Nihon Kohden America, Inc.1985-07-30
ARTERIAL FILTER AFS-XX /FILTER HOLDER AFS-HXX (K851003)Gish Biomedical, Inc.1985-07-29
WHOLEY HI-TORQUE GUIDE WIRES (K852354)Advanced Cardiovascular Systems, Inc.1985-07-29
P.C.A. TOTAL HIP FEMORAL COMPONENT MODIFICATION (K852964)Howmedica Corp.1985-07-29
DOPLETTE 10 (K851269)Imex Medical Systems, Inc.1985-07-29
SLIM VENT UNIPO PACING LEAD USING POLYU 90A,30-281 (K852915)Telectronics, Inc.1985-07-29
MORTARA INSTRUMENT MODEL EL-1 (K851702)Mortara Instrument, Inc.1985-07-29
3.5. MHZ PROBE FOR AUSONICS 150 & 357 REAL TIME CA (K851616)Ausonics Pty , Ltd.1985-07-29
329 CORDIS ENCOR PREVENOUS ARTRIAL & VENTRICULAR (K852253)Cordis Corp.1985-07-29
SLIM ART/J-SVC IND PACING LEAD USING POLY #30-283 (K852917)Telectronics, Inc.1985-07-29
SLIM ART J. BIP PACING LEAD USING POLY #030-2821 (K852918)Telectronics, Inc.1985-07-29
SLIM VENT BIPO PACING LEAD USING A90 INSUL,#30-284 (K852916)Telectronics, Inc.1985-07-29
MEDILOG M3 (K852883)Oxford Medilog, Inc.1985-07-26
MEDILOG M1 (K852884)Oxford Medilog, Inc.1985-07-26
ELA MEDICAL CARDIAC PACEMAKERS MULTIL 2 #1251&2251 (K853017)Ela Medical, Inc.1985-07-25
#335-01 SILIC RUB ISOLA SLEEVE FOR INT #281-03 SIZ (K853034)Intermedics, Inc.1985-07-25
MEDI-TRACE DISPOSABLE PRESSURE TRANSDUCER (K850898)Medi-Trace Products Division1985-07-25
COACH TM- THE AEROBIC FITNESS MONITOR (K851335)Biotechnology, Inc.1985-07-24
HIGH PRESSURE FLEX. CONNECTING TUBING (K841092)Tronomed, Inc.1985-07-24
ECG MONITOR MODEL RM102 (K851496)Honeywell, Inc.1985-07-24
HEWLETT PACKARDT HP 85 W/ VITATRON PH1 PROGRAM HEA (K844484)Vitatron Medical BV1985-07-24
MODEL MB-309H, SHARP DIGITAL BLOOD PRESSURE MONITO (K851664)Sharp Electronics Corp.1985-07-24
HOMEDICA CEMENTED ACETABULAR COMPONENT 6262 (K851565)Howmedica Corp.1985-07-19
SUPRIMA II MODEL 254-26 (K852431)Intermedics, Inc.1985-07-19
SEA MED DDD PACING SYSTEM ANALYZER (K851900)Seamed Corp.1985-07-19
PERCUTANEOUS TRANSLUMINAL BLOOD DILATION CATHETER (K851848)Mansfield Scientific, Inc.1985-07-19
DIGITMATIC DM2 (K851128)Medimatic1985-07-19
SUPRIMA II MODEL 253-23 (K852430)Intermedics, Inc.1985-07-17
SUPRIMA II MODEL 254-28 (K852432)Intermedics, Inc.1985-07-17
CHRONOCOR V EXTERNAL PACER, MODEL 297A (K850822)Seamed Corp.1985-07-16
MEDTRONIC 5311 PACING SYSTEM ANALYZER (K850077)Medtronic Vascular1985-07-16
SCANLAN TUNNELER, SHEATH & TIP (K851825)Scanlan Intl., Inc.1985-07-12
ACCUCOM CARDIAC OUTPUT MONITOR (K851426)Lawrence Medical Systems, Inc.1985-07-12
SIRECUST 425, RESPECTIVELY SIRECUST 430 (K851637)Siemens Medical Solutions USA, Inc.1985-07-12
MODEL 483-06 POLYFLEX IMPLANTABLE PACING LEAD (K851457)Intermedics, Inc.1985-07-11
MEDTRONIC MODEL 5867-1A (K852236)Medtronic Vascular1985-07-11
IMPLANTABLE ELECTRODE ADAPTOR ASSEMBLE (K851461)Telectronics, Inc.1985-07-11
MANAN SELDINGER NEEDLE (K851833)Manan Manufacturing Co., Inc.1985-07-11
KENZ 80Z MARK II (K843731)Suzuken Co., Ltd.1985-07-11
NAMAN POTTS COURNAND NEEDLE (K851832)Manan Manufacturing Co., Inc.1985-07-11
MODEL 493-04 POLYFLEX R IMPLANTABLE PACING LEAD (K851458)Intermedics, Inc.1985-07-11
MANAN GWI GUIDE WIRE INTRODUCER (K851834)Manan Manufacturing Co., Inc.1985-07-11
CARDIAC COOLING JACKET (K851077)Pat O. Daily1985-07-11
BODY ANALYSIS SYSTEM (DEEMED SE 87/09/18) (K851415)Medi-Sport Testing, Inc.1985-07-08
CARDIAC EVENT RECORDER (K843533)Cryo2 Corp.1985-06-28
RMG-9 9 REMOTE MONITOR ACCESS. FOR G-2000 ELECTRO (K851628)Eaton Medical Group1985-06-27
CC-100 CLOCK/CALANDER MODULE ACCESS. FOR G-2000 EL (K851633)Eaton Medical Group1985-06-26
WIRE, GUIDE - MODIFICATION (K850828)Lake Region Mfg., Inc.1985-06-26
WIRE, GUIDE, CATHETER (K850829)Lake Region Mfg., Inc.1985-06-26
SCX-35 THREE CHANNEL ACCESS. FOR MODULE G-2000 ELE (K851626)Eaton Medical Group1985-06-26
SIRECUST 420 PATIENT DIALOG MONITOR (K851400)Siemens Medical Solutions USA, Inc.1985-06-26
GUIDE, WIRE, ANGIOGRAPHIC (K850827)Lake Region Mfg., Inc.1985-06-26
MODEL 9300 TREND ANALYZING BIO-MONITOR SYS (K844252)Medtronic Vascular1985-06-26
CARDIOSTAT 3 RECORDER (K851044)Siemens Elema AB1985-06-26
VENOUS RESERVOIR BAG BMR-1600 (K851376)American Bentley1985-06-25
VENUOS RESERVOIR BAG BMR-1900 (K851401)American Bentley1985-06-25
LASERFLO BLOOD PERFUSION MONITOR 403 (K851057)Tsi, Inc.1985-06-24
MC-4000 SURGICAL INSTRUMENTS CARDIOVASCULAR (K851152)Cryomedics, Inc.1985-06-24
CARDIOVASCULAR CUSTOM SURGICAL KIT (K844593)Xanmed Corp.1985-06-21
FUKUDA DENSHI EH-11 (K834059)Fukuda Denshi USA, Inc.1985-06-21
PERCUTANEOUS ANGIOGRAPHIC NEEDLES (K845037)Mallinckrodt Critical Care1985-06-21
MULTICOR S, MODELS 330A/331A (K851420)Cordis Corp.1985-06-21
MEDTRONIC MODEL 6404 (K851948)Medtronic Vascular1985-06-20
GV MEDICAL, INC. LASTAC BALLOON DILATATION CATHETE (K851080)G V Medical, Inc.1985-06-20
LIGHT REFLECTION RHEOGRAPHY (K852378)Hemodynamics, Inc.1985-06-20
SERIES 7000/HOLTER RECORDER (K851971)Pfizer, Inc.1985-06-20
CENTRIMED SYSTEM 1 W/SYSTEM 1 ADAPTER (K851613)Centrimed Corp.1985-06-19
MODIFICATIONS TO ACS CORONARY GUIDING CATHETER W/T (K851574)Advanced Cardiovascular Systems, Inc.1985-06-19
MDI 2000 - PULSE GENERATOR (K850791)Micromedical Devices, Inc.1985-06-19
POLYMED LAB ARTERIAL EMBOLECTOMY CATHETER (K850015)Polymed Laboratories1985-06-19
TELEFLEX MEDICAL INTRODUCER NEEDLE (K851140)Teleflexmedical, Inc.1985-06-19
CENTRIMED SYSTEM 1 W/MANUAL PUMP DRIVE (K851615)Centrimed Corp.1985-06-19
BIO MEDICUS BIO PUMP MODEL BP-90 (K851855)Bio Medicus, Inc.1985-06-19
MEDTRONIC 5064 (K851890)Medtronic Vascular1985-06-19
CENTRIMED SYSTEM 1 W/24 VOLT BATTERY POWER SUPPLY (K851614)Centrimed Corp.1985-06-19
COBE GAS FILTER (K851289)Cobe Laboratories, Inc.1985-06-19
WHOLEY HI-TORQUE GUIDE WIRES (K852123)Advanced Cardiovascular Systems, Inc.1985-06-19
CORDIS MULTICOR S 330A & 331A CARDIAC PACEMAKERS (K844360)Cordis Corp.1985-06-18
AMBULATORY PH RECORDING DEVICE (K842349)Clinical Data Instruments, Inc.1985-06-14
SHARP DIGITAL BP MONITOR MB-371H (K850830)Sharp Electronics Corp.1985-06-13
OXFORD VDT-40 DISPLAY TERMINAL (K852207)Oxford Medilog, Inc.1985-06-11
OMNI-ATRICOR MODEL 308A (K851418)Cordis Corp.1985-06-11
DISPOS. PRESSURE KIT 1295K SERIES (K843273)Hewlett-Packard Co.1985-06-11
STANICOR GAMMA 333B/334A (K851416)Cordis Corp.1985-06-11
DOSIMETRIC RELEASE OF RAD. TUBING PAC (K833047)American Bentley1985-06-11
NORELCO ELECTRONIC DIGITAL BLOOD PRESSURE METER (K852037)Philips Park1985-06-11
CORDIS ELECTROPHYSIOLOGY STIMULATOR (K844815)Cordis Corp.1985-06-11
MULTICOR GAMMA MODELS 336/337 (K851417)Cordis Corp.1985-06-11
MULTICOR GAMMA 402 SERIES PACER (K851419)Cordis Corp.1985-06-11
LEVEEN INFLATOR DISPOSABLE INFLATION SYRINGE (K851402)Medi-Tech, Inc.1985-06-10
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