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Cardiovascular

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

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RecordFirmDate
OPUS MODELS 4033 AND 4034 (K894267)Ela Medical, Inc.1989-09-20
10 FR PERCUTAN DOUBLE LUMEN INTRA-AORTIC BALLOON (K892797)Kontron Instruments, Inc.1989-09-20
RMI ARTERIAL PERFUSION CANNULA (K894243)Research Medical, Inc.1989-09-19
NR5000 E.C.G. AND PULSE OXIMETER MONITOR (K894919)Nirad , Ltd.1989-09-18
DAIG ELECTROPHYSIOLOGY CATHETER (K894500)Daig Corp.1989-09-18
CATHETER INTRODUCER SHEATH (K890766)Applied Vascular Devices, Inc.1989-09-18
TRI-LUMEN INTRA VASCULAR BALLOON CATHETER (K891021)Ideal Medical, Inc.1989-09-18
ASC-952 PHYSIOLOGICAL AMPLIFIER (K894735)Astro-Med, Inc.1989-09-18
MODEL 6888 LEAD TUNNELER (K894738)Cardiac Pacemakers, Inc.1989-09-13
KONTRON INTRA-AORTIC BALLOON PUMP MODEL K9000 (K892878)Kontron Instruments, Inc.1989-09-13
ELECTROTRACE DISP. RESTING EKG ELECTRODES (K894679)Jason Marketing Co.1989-09-13
DISP. ACCESSORY TO EXTERNAL TRANS. CARDIAC PACE. (K891122)Big Valley Medical1989-09-13
CARDIAC OUTPUR/SATURATED VENOUS OXYGEN MODULE (K893867)Spacelabs, Inc.1989-09-13
GUIDEWIRE (K890959)Guidewire Technologies, Inc.1989-09-12
DAIG VESSEL DILATOR (K894330)Daig Corp.1989-09-12
USCI UNCOATED GUIDING CATHETERS (K894682)C.R. Bard, Inc.1989-09-12
OPTIMA MPT AND SPT PACEMAKERS (K891231)Telectronics, Inc.1989-09-12
EPLAB (ELECTROCARDIOGRAPHIC MONITOR) (K893836)Quinton Electrophysiology Corp.1989-09-08
MODIFIED LABELING TO PERMANENT LEAD INTRODUCER (K894431)Daig Corp.1989-09-06
ARBO H79P DISPOSABLE MONITORING ELECTRODES (K894562)Arbo Medical, Inc.1989-09-05
VERIPOID 50 BIO-ELECTRICAL IMPEDANCE METER (K893963)V.S.B.B. Technologies, Inc.1989-09-05
STEALTH DILATION CATHETER SYSTEM (K893411)Target Therapeutics1989-09-05
ADAPTAID(TM) ADAPTER SLEEVE MODEL 366-33 (K894718)Intermedics, Inc.1989-09-05
ARBO TAB DISPOSABLE DIAGNOSTIC RESTING EKG ELECTRO (K894648)Arbo Medical, Inc.1989-09-05
BARD CATH LAB THERMODILUTION CATHETER (K893474)C.R. Bard, Inc.1989-09-05
OXIMETER (K893587)Radiometer America, Inc.1989-09-05
DIGITAL TRANSTELEPHONIC ECG MONITORING SYSTEM (K892370)Bio-Focus, Inc.1989-08-28
EDENTRACE 670 SYSTEM MULTICHANNEL RECORDER W/OXIM. (K893561)Edentec Corp.1989-08-25
MINIX 8341M AND MINIX ST 8331M PULSE GENERATORS (K894055)Medtronic Vascular1989-08-25
PULSE TIME PRODUCTS LIMITED, PM-3 (K892795)Pulse Time Products, Ltd.1989-08-25
HOME BLOOD PRESSURE KIT, ANEROID (K884420)Yamasu Co. , Ltd.1989-08-25
PULSE TIME PRODUCTS LIMITED, PM-2 (K892794)Pulse Time Products, Ltd.1989-08-25
MODEL 5650 OPTIMATE PERSONAL PROGRAMMER (K884522)Teletronics, Inc.1989-08-25
MODEL 3110 HEART WIRE & 3110P PEDIATRIC HEART WIRE (K890988)Pace Medical1989-08-25
ELECTRONIC BLOOD PRESSURE MONITORS (K894062)Hanson Scale Co.1989-08-24
USCI PTA BALLOON DILATATION CATHETER (K890405)C.R. Bard, Inc.1989-08-17
C.A.B. RING (K894268)Medi-Sharp, Inc.1989-08-17
OPTIMA MPT SERIES III PACEMAKER, UNIPOLAR/BIPOLAR (K894185)Telectronics Pacing Systems, Inc.1989-08-17
USCI PROBING CATHETER (K890152)C.R. Bard, Inc.1989-08-17
TARGET CATHETERS AND GUIDE WIRES FOR PEDIATRIC USE (K894084)Target Therapeutics1989-08-17
USCI PROBE LINX EXTENSION WIRE (K890404)C.R. Bard, Inc.1989-08-17
GENERAL SURGICAL INSTRUMENTS (K894670)Nopa Instruments1989-08-10
INTRO-FLEX SHEATH INTRODUCER W/AMC THROMBOSHIELD (K885179)Baxter Healthcare Corp1989-08-09
USCI CORONARY INFUSION CATHETER (K891069)C.R. Bard, Inc.1989-08-09
MODIFIED LABEL TO PERCU. INTRO. W/SIDEPORT & 3-WAY (K894430)Daig Corp.1989-08-09
CARDIAC COMPUTATION SOFTWARE PACKAGE (K890636)Elscint, Inc.1989-08-07
VOLUME COMPUTATION SOFTWARE PACKAGE (K890638)Elscint, Inc.1989-08-07
PERCUTANEOUS INTRODUCER (K893658)Medamicus, Inc.1989-08-03
BURRON TEFLON-COATED GUIDEWIRE (K884183)Burron Medical, Inc.1989-08-03
SENSOCOR TM R-TEST 24OXL (K894234)Sensocor1989-08-03
MODELS HP 43110MC, 43200MC W/CASE & 43200M NO CASE (K893403)Hewlett-Packard Co.1989-08-03
SIEMENS SAO2 + PULS OXIMETRY CARTRIDGE (K893470)Siemens Medical Electronics1989-08-03
SARNS PRESSURE ADJUSTABLE SAFETY SYSTEM (K893683)3M Company1989-08-03
INTRAVASCULAR CATHETER WITH HYDROPHILIC COATING (K891580)Boston Scientific Corp1989-08-03
ASC-950 ECG AMPLIFIER (K894161)Astro-Med, Inc.1989-08-03
SILICONE BI-LUMEN IRRIGATION EMBOLECTOMY CATH. (K893680)Cathlab Corp.1989-08-01
DVM-4200 BLOOD FLOWMETER (K892707)Koven and Assoc., Inc.1989-07-28
MEDTRONIC MODEL 9443 IN-OFFICE TRANSMITTER (K894140)Medtronic Vascular1989-07-27
IMEX RHYTHM TEK (K890114)Racom, Inc.1989-07-27
ANGIOGRAPHY CUSTOM PACKS (K891572)Procedure Packs, Inc.1989-07-24
FOGARTY(R) THRU-LUMEN EMBOLECTOMY CATHETER (K892410)Baxter Healthcare Corp1989-07-20
INTERSPEC TRANSESOPHAGEAL PROBE MODEL 4515 (K892944)Interspec, Inc.1989-07-19
CARDIOCAP(TM) DR-104 REPORTER (K885058)Datex Division Instrumentarium Corp.1989-07-14
MODELS 1113 AND 1114 PACEMAKER LEADS (K893763)Possis Medical, Inc.1989-07-14
MODEL V420 DIRECT PRESSURE MONITOR & 427 WAVEFORM (K893232)Camino Laboratories, Inc.1989-07-14
IMPLANTABLE PACING LEADS W/IS-1 CONN., UNIPOLAR (K894040)Medtronic Vascular1989-07-14
BARD PLAQUE ELECTRODE ARRAY (K893611)Bard Electrophysiology1989-07-14
SHILEY EQUIPMENT SUPPORT CARTS ESC-002 & ESCB-02 (K892446)Shiley, Inc.1989-07-14
DISPOSABLE TRANSDUCER MANIFOLD (K890676)L.O.N. Research, Inc.1989-07-14
NEWCHILL(TM) CARDIAC INSULATOR (K892804)Acacia Laboratories, Inc.1989-07-14
MYOPORE(TM) UNIPOLAR SUTURELESS MYOCARDIAL LEADS (K885175)Possis Medical, Inc.1989-07-14
MODIFIED STERILIZATION METHOD OF PTI HEART-LIFT (K893436)Pioneering Technologies, Inc.1989-07-14
VITATRACE (K893425)Lectec Corp.1989-07-14
SONOMICROMETER, ULTRASONIC DIMENSION SYSTEM, CARD. (K885349)Sonotek Corp.1989-06-22
PCA-10, 10CC DISP. ANGIOGRAPHY CONTROL SYRINGE (K890292)Coeur Laboratories, Inc.1989-06-22
SEER (K882818)Marquette Electronics, Inc.1989-06-22
MODIFIED GELMAN ARTERIAL FILTER (K892387)Gelman Sciences, Inc.1989-06-22
ACTA GENOS ELECTROCARDIOGRAPH (K884800)Parexel Intl. Corp.1989-06-22
HORIZON CENTRAL STATION (K892066)Mennen Medical, Inc.1989-06-22
BP-8800 BLOOD PRESSURE MONITOR (K890876)Colin Medical Instruments Corp.1989-06-22
EDENTEC MODEL 2001 MODULAR MEMORY UNIT (MMU) (K892227)Edentec Corp.1989-06-20
MODEL 5330 EXTERNAL A-V SEQUENTIAL DEMAND PULSE (K893633)Medtronic Vascular1989-06-20
PACEMAKER LEAD ADAPTER (K890018)Ela Medical, Inc.1989-06-20
GUIDE WIRE INTRODUCER (K890807)Datascope Corp.1989-06-20
L30-LB- INFANT LIMB BAND (K893245)Contour Electrodes, Inc.1989-06-20
SHOCK ADVISORY ADAPTER FOR USE W/LIFEPAK 9 (K892005)Physio-Control Corp.1989-06-20
PERIFLUX PF3 (K890828)Perimed, Inc.1989-06-20
CPM-1 SYSTEM OXIMETER/CARDIAC OUTPUT COMPUTER (K893392)Baxter Healthcare Corp1989-06-20
INTRA AORTIC BALLOON (K893243)Datascope Corp.1989-06-20
USCI GREY/BLACK GUIDE WIRE (K890505)C.R. Bard, Inc.1989-06-20
DAIG PACEL(TM) FLOW DIRECTED PACING CATHETER (K890794)Daig Corp.1989-06-20
MAX-1 (EXERCISE ELECTROCARDIOGRAPH) (K890323)Marquette Electronics, Inc.1989-06-16
TRANSESOPHAGEAL ULTRASOUND ACCESSORIES KIT (K891180)Ingress Technologies, Inc.1989-06-15
AUTO SUTURE SURGIPORT DEPTH GUIDE AND SKIRT (K893707)United States Surgical, A Division of Tyco Healthc1989-06-15
ROBICSEK INTRACARDIAC SUCTION WAND (K891906)Gish Biomedical, Inc.1989-06-13
PARAMED MODEL 9350 BLOOD PRESSURE MONITOR (9350) (K890198)Paramed Technology, Inc.1989-06-12
FRANZ(TM) MOVEABLE STYLET MAP CATHETER, MODIFIED (K892207)Ep Technologies, Inc.1989-06-12
ROTATING HEMOSTATIC VALVE (K890800)Datascope Corp.1989-06-12
RESUBMITTAL OF MI 1000C MICROIMAGER (K881979)Ausonics Pty , Ltd.1989-06-12
ATRAUMAX(TM) SURGICAL CLAMPS (K891296)Applied Vascular Devices, Inc.1989-06-07
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