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Cardiovascular

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

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RecordFirmDate
BIOZ SYSTEM (K963183)Cardiodynamics International Corp.1996-11-26
NELLCOR SYMPHONY N-3000 PATIENT MONITOR WITH SPO2 AND ECG AND N-3200 DISPLAY/PRINTER (K963400)Nellcor Puritan Bennett, Inc.1996-11-26
OXI TEMP (K963496)Bci Intl., Inc.1996-11-26
TRACE RITE SOLID GEL ECG ELECTRODES (K964213)Bio-Detek, Inc.1996-11-25
VASCUTEK CARDIOVASCULAR FABRIC: VASCUTEK GELSEAL PATCH,VASCUTEK GELSOFT PATCH,VASCUTEK THIN WALL CAROTID PATCH (K963611)Vascutek, Ltd.1996-11-21
TEBCO (THORACIC ELECTRICAL BIOIMPEDANCE CARDIAC OUTPUT) (K962128)Hemo Sapiens, Inc.1996-11-21
VITALMAX 4000/MINIPACK 3100/3000 (K951226)Pace Tech, Inc.1996-11-21
MEDTRONIC MUSTANG STEERABLE GUIDE WIRE (M-45FR, M45FX) (K961917)Medtronics Interventional Vascular1996-11-20
MEDI-TRACE 5700 RESTING ECG ELECTRODE (K963151)Graphic Controls Corp.1996-11-19
BURKE CONGENITAL THORACOSCOPY INSTRUMENTS (K962771)Pilling Weck, Inc.1996-11-19
CARDIOSERV S (K962551)Marquette Electronics, Inc.1996-11-19
SCHNEIDER GUIDER SOFTIP GUIDING CATHETERS (K961999)Boston Scientific Scimed, Inc.1996-11-19
SIMON NITINOL FILTER SYSTEM (K963016)Nitinol Medical Technologies, Inc.1996-11-18
SIMON NITINOL FILTER/STRAIGHT LINE SYSTEM (K963014)Nitinol Medical Technologies, Inc.1996-11-18
INTRA-AORTIC BALLOON PUMP SYSTEM 97 MODIFIED (K961509)Datascope Corp.1996-11-15
MEDI-TRACE 3600 SERIES OF ECG MONITORING ELECTRODE (K963038)Graphic Controls Corp.1996-11-15
HEARTPORT MULTIFIRE CLIP APPLIER (K961333)Heartport, Inc.1996-11-15
FULL AUTO WRIST BLOOD PRESSURE METER MODEL SE-5000 (K952827)Sein Electronics Co., Ltd.1996-11-14
FULL AUTO FUZZY BLOOD PRESSURE METER MODEL SE-7000 (K952826)Sein Electronics Co., Ltd.1996-11-14
UNIPOLAR IPG GROUND CABLE, MODEL 5473 (K961520)Medtronic Vascular1996-11-13
CORDIS ST STEERABLE GUIDEWIRE (K963214)Cordis Corp.1996-11-13
PACE-1A CARDIAC STIMULATOR (K963579)Radionics, Inc.1996-11-08
EXTERNAL PACEMAKER ANALYZER, MODEL PMT 100 (K961582)North American Technical Services Corp.1996-11-08
CATH SEAL (K962180)Universal Medical Instrument Corp.1996-11-07
HEARTPORT CABLE BULLDOG CLAMP (K962366)Heartport, Inc.1996-11-07
CINCH QR SGW EXTENSION (K963171)Cordis Corp.1996-11-07
WLP GRADIENT SEQUENTIAL VERSION/WLP PROLITE/WLP WLP-II LITE (K961797)Wright Linear Pump, Inc.1996-11-06
WLP SINGLE-SEGMENT VERSION WLP SOLO VII (K961891)Wright Linear Pump, Inc.1996-11-06
WLP SEQUENTIAL VERSION MODEL WLP SOLO VI, WLP SOLO SEQUENTIAL (K961292)Wright Linear Pump, Inc.1996-11-06
MODIFIED LABELING OF CARDIAC ASSIST INTRA-AORTIC BALLOON CATHETERS: MODEL 930 - 940, 30 - 40 CC SENSATION AND NICATH 30C (K963187)Boston Scientific Corp1996-11-04
LIFEPAK 500 (K955854)Physio-Control Corp.1996-11-04
MICROFERRET CATHETER (K961668)Cook, Inc.1996-11-04
AMR-ACV CLAMPS (K962668)Applied Medical Resources1996-11-04
INTERMEDICS MODEL 436-07 BIPOLAR & MODEL 437-07 UNIPOLAR IMPLANTABLE ENDOCARDIAL PACING LEAD (K955122)Intermedics, Inc.1996-11-04
MAXIMA FORTE HARDSHELL VENOUS RESERVOIR (K961836)Medtronic Vascular1996-11-01
AUTOMATIC TUBING CLAMP SYSTEM (ATC) (K961364)Rocky Mountain Research, Inc.1996-10-31
BARD WILLIAM HARVEY HF-6000 MEMBRANE OXYGENATOR (K954850)C.R. Bard, Inc.1996-10-30
BARD QUANTUM CVR (K962726)C.R. Bard, Inc.1996-10-30
DEFIBRILLATOR ANALYZER, DELTA 1000 (K961595)Netech Corp.1996-10-29
ELS AUTOMATIC TUBING CLAMP SYSTEM (K961598)Rocky Mountain Research, Inc.1996-10-29
MEDI-TRACE 200, MEDI-TRACE 200-30 (K960968)Graphic Controls Corp.1996-10-28
EUREDUC PNEUMATIC DRAINAGE SYSTEM (K954788)Eureduc1996-10-28
KSEA MODEL 383320 20 ANGIOMAT (K960486)Karl Storz Endoscopy1996-10-25
CORDIS STABILIZER PLUS XS (K962932)Cordis Corp.1996-10-25
MEDI-TRACE COMBINATION DEFIBRILLATION & ECG ELECTRODE FOR LAERDAL (K955923)Graphic Controls Corp.1996-10-24
MEDI-TRACE COMBINATION DEFIBRILLATION & ECG ELECTRODE FOR HEWLETT PACKARD DEFIBRILLATORS (K955882)Graphic Controls Corp.1996-10-24
USCI PRO FLO XT,SOFT TIP, AND XT SOFT TIP ANGIOGRAPHIC (K960056)C.R. Bard, Inc.1996-10-23
CORDIS OPTA PTA BALLOON CATHETER (K962945)Cordis Corp.1996-10-23
AS/3 LIGHT MONITOR (K961247)Datex Division Instrumentarium Corp.1996-10-23
ELECTRODE RECORDING CATHETER (K954651)Boston Scientific Corp1996-10-22
VISTA BRITE TIP CATHETERS (K962830)Cordis Corp.1996-10-17
ARROW BIPOLAR PACING/BALLOON WEDGE PRESSURE CATHETER (K960479)Arrow Intl., Inc.1996-10-17
LAGUNA SOFTIP DIAGNOSTIC CATHETERS (K961499)Boston Scientific Scimed, Inc.1996-10-17
LOG-A-RYTHM MODEL 100 AND MODEL 1001 (K952790)Nian-Crae, Inc.1996-10-17
CAPIOX SX10 HOLLOW FIBER OXYGENATOR WITH DETACHABLE HARDSHELL VENOUS RESERVOIR (K960074)Terumo Medical Corp.1996-10-16
SPYGLASS ANGIOGRAPHIC CATHETER (K962805)Daig Corp.1996-10-15
FLOWTRON EXCEL PUMP (K961166)Hne Healthcare, Inc.1996-10-11
CORDIS AVANTI TRANS-RADIAL CATHETER SHEATH INTRODUCER KIT (K962746)Cordis Corp.1996-10-11
TRIMFLO PARENCHYMAL BLOOD FLOW MONITORING PROBE KIT (K961368)Vasamedics, LLC1996-10-11
USCI BIPOLAR BALLOON PACING ELECTRODE WITH BH COATING (K955712)C.R. Bard, Inc.1996-10-11
HP M2600A OMNICARE TELEMETRY SYSTEM MODEL M2600A (K961165)Hewlett-Packard Co.1996-10-10
OHMEDA 3800 PULSE OXIMETER (K962127)Ohmeda Medical1996-10-10
4F NYLEX ANGIOGRAPHIC CATHETER (K962759)Cordis Corp.1996-10-10
HP CATHSTATION - MODEL M1264B (K961401)Hewlett-Packard Co.1996-10-08
CARDIOVIEW TRANSTELEPHONIC SOFTWARE (K955891)Micromedical, Inc.1996-10-08
CAPIOX SX25 HOLLOW FIBER OXYGENATOR WITH DETACHABLE HARDSHELL RESERVOIR (K962667)Terumo Medical Corp.1996-10-07
RNS STERILE, DISPOSABLE CT BIOPSY TRAY (K955685)Contour Fabricators of Florida, Inc.1996-10-04
IMPRA CARBOFLO EPTFE VASCULAR GRAFT (K962639)Impra, Inc.1996-10-03
EAGLE 3000/3100 PATIENT MONITOR (K960272)Marquette Electronics, Inc.1996-10-02
DANESHVAR WOUND SUPPORT UNIT (K955827)Y. Daneshvar1996-10-02
EAGLE PATIENT MONITOR (K960418)Marquette Electronics, Inc.1996-10-02
CAPIOX SX18 HOLLOW FIBER OXYGENATOR WITH AND WITHOUT DETACHABLE HARDSHELL RESERVOIR (K961000)Terumo Medical Corp.1996-10-02
B. BRAUN GUIDEWIRES (K961107)B.Braun Medical, Inc.1996-10-01
HEARTPORT ENDOVASCULAR CARDIOPULMONARY BYPASS SYSTEM ANTEGRADE SYTEM (CATALOG NUMBER ECPB-A) ANTEGRADE/RETROGRADE SYSTEM (K962858)Heartport, Inc.1996-09-30
MAGLIFE (K950264)Odam1996-09-27
UNIPOLAR & BIOPLAR IMPLANTABLE ENDOCARDIAL PACING LEADS, WITH SILICONE RUBBER INSULATION & PASSIVE FIXATION (K953044)Biotronik, Inc.1996-09-27
EUREDUC PNEUMATIC DRAINAGE SYSTEM MODEL TP03 (K960902)Eureduc1996-09-26
VASO-SAFE ARTERIAL EMBOLECTOMY CATHETE (K961716)Ideas For Medicine, Inc.1996-09-19
CONTRAST INJECTION LINES (K960674)B.Braun Medical, Inc.1996-09-19
CORDIS WEBSTER T20 DIAGNOSTIC DEFLECTABLE TIP CATHETER (K953663)Cordis Webster, Inc.1996-09-18
RHYDER DIAGNOSTIC CATHETER (K962307)Fidus Medical Technology Corp.1996-09-17
RV PACING LEAD (K962467)Abbott Laboratories1996-09-17
BRAUN PERCUTANEOUS INTRODUCER SET (K961745)B.Braun Medical, Inc.1996-09-17
BIPORE BALLOON DILATATION CATHETER (K961980)Bipore, Inc.1996-09-12
FRONT LOAD INJECTOR TURRET MODEL 859-0001/200 ML FRONT LOAD SYRINGE MODEL 853-0211 (K960965)Coeur Laboratories, Inc.1996-09-12
INDEFLATOR PLUS 30/PLUS 30 PRIORITY PACK9WITH THE.096 OR.115 ROTATING HEMOSTATIC VALVE) (K962495)Advanced Cardiovascular Systems, Inc.1996-09-12
E100A PULSE OXIMETER FINGER SENSOR/PROBE (K954168)Epic Medical Equipment Services, Inc.1996-09-12
PERCUTANEOUS INTRODUCER SET (K961466)Thomas Medical Products, Inc.1996-09-12
HEARTPORT ENDOAORTIC CLAMP (K962510)Heartport, Inc.1996-09-11
CARD GUARD MODEL CG-6500 (K954350)Card Guard Scientific Survival , Ltd.1996-09-10
FORE RUNNER EXTERNAL DEFIBRILLATOR/DEFIBRILLATOR PADS (K955628)Heartstream, Inc.1996-09-10
HEMASHIELD FINESSE ULTRA-THIN, KNITTED CARDIOVASCULAR PATCH (K962342)Meadox Medicals, Div. Boston Scientific Corp.1996-09-10
0.014 INCH EXTRA LONG FLOPPY AND 0.014 EXTRA LONG INTERMEDIATE GUIDE WIRES WITH PHOSPHORYLCHOLINE (PC) POLYMER COATING (K962266)Biocompatibles Cardiovascular, Inc.1996-09-10
PERSONAL TELEMEDICINE SYSTEM (K952882)American Telecare, Inc.1996-09-09
PRUITT-INAHARA CAROTID SHUNT 400-40-8F/INAHARA-PRUITT CAROTID SHUNT 500-50-8F (K960715)Ideas For Medicine, Inc.1996-09-09
NEWMED ABP-LITE (K955887)Newmed Corp.1996-09-05
THUMPER CARDIOPULMONARY RESUSCITATOR (K962237)Michigan Instruments, Inc.1996-09-05
BETTER-VENTER (K961594)Circulatory Technology, Inc.1996-09-05
BARD TAPERSEAL INTRA-AORTIC BALLOON CATHETER & INTRODUCER KIT (K962177)C.R. Bard, Inc.1996-09-04
CAMBRIDGE HEART HI-RES ECG ELECTRODE (K962115)Cambridge Heart, Inc.1996-08-29
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