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Cardiovascular

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

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RecordFirmDate
4240 DYNAMIC BP/HEART RATE MONITOR (K914260)Suntech Medical Instruments, Inc.1992-09-04
AUTOTRANSFUSION BLOOD COLLECTION RESERVOIR (K915737)Electromedics, Inc.1992-09-03
DUAL LEAD (ECG1 & ECG2) ARRHYTHMIA ANALYSIS (K920743)Nihon Kohden America, Inc.1992-09-03
LEOCOR CORFLO PUMP -- MODIFICATION (K924110)Leocor, Inc.1992-09-01
LUKENS 2-0 BRAIDED SILK SUTURES (K922254)Quinton, Inc.1992-09-01
USCI LINX EZ GUIDE WIRE EXTENSION W/PRO/PEL COAT (K920980)C.R. Bard, Inc.1992-08-24
TEC ROTATING DUAL HEMOVALVE (K912664)Intensive Technology, Inc.1992-08-24
COWBOY II (K920308)Kinetic Concepts, Inc.1992-08-24
GUIDEWIRES, VARIOUS TYPES (K920884)Acme-Monaco Corp.1992-08-19
MEDILOG EXCEL ECG ANALYSIS SYSTEM (MODIFIED) (K920295)Oxford Medilog, Inc.1992-08-18
SCIMED VIPER CATHETER (K915347)Scimed1992-08-17
NEW EXTRUSION VENDOR FOR POLYURETHANE TUBING (K914489)Telectronics Pacing Systems, Inc.1992-08-17
CPI MODEL 2215 (K923398)Seamed Corp.1992-08-14
CATHETER INTRODUCER (K920528)Boston Scientific Corp1992-08-12
ACS ANGIOTRAK(TM) SYSTEM (K921719)Advanced Cardiovascular Systems, Inc.1992-08-07
BAIR HUGGER TORSO BLANKET - ARMS IN MODEL 540 (K921165)Augustine Medical, Inc.1992-08-06
POLYCATH #WMC-900 (K912270)Worldwide Medical1992-08-05
ADAPTING SLEEVE KIT MODEL 4023 (K921318)Siemens-Pacesetter, Inc.1992-08-03
MODELS M1722A, M1723A, M1724A DEFIBRILLATORS (K915757)Hewlett-Packard Co.1992-07-30
MEDRAD MCT-PLUS INJECTOR (K913624)Medrad, Inc.1992-07-30
LIFE-TEL L.B.E. (LIFE-PAK 5 BATTERY ELIMINATOR) (K922563)Raco Products Co.1992-07-28
CATHETER TWO STAGE VENOUS RETURN (K915268)Dlp, Inc.1992-07-27
JAGWIRE(TM) RECANALIZATION GUIDEWIRE (K922302)Boston Scientific Corp1992-07-24
MEDROYAL ANGIOGRAPHIC CONTROL SYRINGE (K920135)Medroyal, Inc.1992-07-24
CUFF-M (K921997)Lorin Medical, Inc.1992-07-23
SCIMED AVENUE CORONARY GUIDEWIRE INSERTION TOOL (K922410)Scimed Life Systems, Inc.1992-07-23
PIM 1.0 LASER DOPPLER PERFUSION IMAGER (K920844)Lisca Development AB1992-07-21
TOTAL CROSS .021 PERCUT. TRANSLUMINAL ANGIO. CATH. (K921856)Schneider Intl., Ltd.1992-07-21
CBIS CATHETER PULL-BACK DEVICE (K921879)Cardiovascular Imaging Systems, Inc.1992-07-16
NOVAMETRIX MODEL 7100 COMB. END TIDAL CO2 & PUL OX (K920379)Novametrix Medical Systems, Inc.1992-07-15
ACCUTRACKER DX (K913844)Suntech Medical Instruments, Inc.1992-07-14
UPH-2000 UNIVERSAL OXIMETRY PROBE HOLDER (K914538)Innovative Medical Products, Inc.1992-07-14
VERSA-VIAL (K920177)Bioteque America, Inc.1992-07-13
CARDIO-CARD ECG MANAGEMENT SYSTEM (K920020)Nasiff Assoc., Inc.1992-07-09
SARNS 8000 MODULAR PERFUSION SYSTEM (K915183)3M Health Care, Sarns1992-07-08
EMD TRANSTELEPHONIC RECORDER AND RECEIVER # 1200 (K920765)Electronic Monitoring Devices, Inc.1992-07-07
LIFE-TEL L.B.E.(LIFE-PAK 5/10 BATTERY ELIMINATOR) (K920990)Raco Products Co.1992-07-06
ECG MODULATOR (K922412)Maguire Ent., Inc.1992-07-06
SHERPA GUIDING CATHETER WITH CATHETER INTRODUCER (K915351)Medtronics Interventional Vascular1992-06-29
GEL-TAC (K915328)Katecho, Inc.1992-06-29
P-300 CAPNOGRAPH AND PULSE OXIMETER (K915773)Pryon Corp.1992-06-24
TYPE 9050/NEO (K912183)S & W Medico Teknik1992-06-23
JOBST EXTREMITY PUMP SYSTEM 7500 (K921562)Jobst Institute, Inc.1992-06-22
BAIR HUGGER CUB BLANKET- SHORT MODEL 536 (K920432)Augustine Medical, Inc.1992-06-18
ARROW QUADPOLAR MAPPING/PACING CATHETER (K911065)Arrow Intl., Inc.1992-06-18
SCHNEIDER MONORAIL 421 PERCU TRANS ANGIO (PTA) BAL (K921943)Schneider Intl., Ltd.1992-06-17
MODEL #225-ST SHOCK-TRODE ADULT DEFIB PADS STERILE (K922227)Cardiotronics, Inc.1992-06-11
MODEL # 230 ST STEALTH-TRODE DEFIB PADS (STERILE) (K922172)Cardiotronics, Inc.1992-06-11
MODEL # 830 ST ADULT STIMULATION PADS (STERILE) (K922173)Cardiotronics, Inc.1992-06-11
MORSE HEMOSTATIC CATHETER INTRODUCER SET (K915078)North American Instrument Corp.1992-06-10
.10' HI-TORQUE FLOPPY, INTER. & STAND. GUIDE WIRE (K915723)Advanced Cardiovascular Systems, Inc.1992-06-09
SCIMED(R) CONTROLWIRE(TM) GUIDE WIRE (K914194)Scimed Life Systems, Inc.1992-06-09
R-GROUP INTL. ONE WALL PUNCTURE NEEDLE (K913267)R-Group Intl.1992-06-05
STEALTH DILATION CATHETER SYSTEM (MODIFIED) (K915895)Target Therapeutics1992-06-04
CARDIAC CATHERIZATION KIT (K914299)Abbott Laboratories1992-06-03
FAST-CATH HEMOSTASIS INTRODUCER (K920779)Daig Corp.1992-06-03
INTRODUCER CATHETER (K915625)Interventional Therapeutics Corp.1992-06-03
GORE TUNNELER, MODIFICATION (K920998)W. L. Gore & Associates, Inc.1992-06-03
CRIT-SCAN (K910077)Noninvasive Medical Technology Corp.1992-06-02
SILCLAMPS DEGANIA SILICONE (K920501)Puritas Health Care, Inc.1992-06-02
BSM-2100A CONFIGURED PATIENT MONITOR (K914092)Nihon Kohden America, Inc.1992-05-28
BR-50-J DISPOSABLE ECG ELECTRODE (K921579)Medicotest, Inc.1992-05-26
MODEL #125 CHILD STIMULATION PADS (K921606)Cardiotronics, Inc.1992-05-26
MODELS 6917T, 6917AT & 4951M EPICARDIAL PACE LEADS (K921124)Medtronic Vascular1992-05-22
LIFESTREAM CENTRIFUGAL PUMP SYSTEM MODEL 2100CP (K921550)St. Jude Medical, Inc.1992-05-21
E-Z-FLOW ANGIOGRAPHY CATHETERS, MODIFICATION (K914984)E-Z-Em, Inc.1992-05-20
HIGH PRESSURE CONNECTING SETS, MODIFICATION (K914987)E-Z-Em, Inc.1992-05-20
MEDTRONIC BIO-MEDICUS BIO-CONSOLE MODEL 540-D (K914754)Medtronic Bio-Medicus, Inc.1992-05-20
GUIDE WIRES, MODIFICATION (K914986)E-Z-Em, Inc.1992-05-20
ACCESSORY TO GENESIS III (GCFM) (K913209)Biosound, Inc.1992-05-15
K-DEFIB/PACE ELECTRODE (K914955)Katecho, Inc.1992-05-14
CAMBRIDGE PC/GXT STRESS TEST SYSTEM (K921331)Health Watch, Inc.1992-05-11
RHYTHMSCAN PRECISION 6000 (K914577)Precision Health Care Systems, Inc.1992-05-08
ULTRA-THIN (K920547)Boston Scientific Corp1992-05-06
VASCULAR CATHETER & WIRE GUIDES W/MEDI-COAT(TM) (K914856)Cook, Inc.1992-05-01
HMS-4000 PHYSIOLOGICAL MONITOR, MODIFICATION (K914620)Vitalog Monitoring,Inc.1992-05-01
ZB-860PA MULTIPARAMETER TRANSMITTER (K913117)Nihon Kohden America, Inc.1992-04-29
K3 COMPUTER SYSTEMS (K902977)Donald L. King M.D.1992-04-28
ESCORT-LINK ARRHYTHMIA OPTION 23L (K915153)Medical Data Electronics1992-04-27
INTRALUMINAL ARTERY STRIPPER (K913803)Omni-Tract Surgical, Div. Minn. Scientific, Inc.1992-04-24
RIGHT ATRIAL CATHETER KITS (K920331)Akcess Medical Products, Inc.1992-04-22
FEMOSTOP (K915280)Radi Medical Systems AB1992-04-22
LIFE-AIR 1000 HYPOTHERMIC TREATMENT SYSTEM (K914382)Progressive Dynamics, Inc.1992-04-21
IDENTI LOOPS DEGANIA SILICONE (K920104)Puritas Health Care, Inc.1992-04-20
TARGET THERAPEUTICS COILS (K914786)Target Therapeutics1992-04-20
MILLAR NONMAGNECTIC MIKRO-TIP CATHETER PRESS. TRAN (K915775)Millar Instruments, Inc.1992-04-20
CORDIS ANGIOGRAPHIC DOPPLER CATHER (K915498)Cordis Corp.1992-04-17
DAIG FAST CATH TRANSSEPTAL SHEATH INTRODUCER (K920327)Daig Corp.1992-04-16
RMI SOFCLAMP (K920676)Research Medical, Inc.1992-04-15
A-V IMPULSE SYSTEM (K914461)Novamedix , Ltd.1992-04-15
PACEART CPTS-86/12 (K915632)Paceart, Inc.1992-04-14
PRESS 1 PRESS 2 9220 UPDATING OF THE MODULE (K912816)S & W Medico Teknik1992-04-10
EME MP3000 MONITORING AND DIAGNOSTIC RESTING ECG (K920867)Electro Medical Equipment Co., Inc.1992-04-10
DESERET GUIDEWIRE INTRODUCER III (K920408)Bd Becton Dickinson Vacutainer Systems Preanalytic1992-04-07
DESERET GUIDEWIRE INTRODUCER II (K920407)Bd Becton Dickinson Vacutainer Systems Preanalytic1992-04-07
UNISCAN 24 ECG ROCORDER (K920572)Uniscan , Ltd.1992-04-06
ARS-EKG 12K INTERPRETIVE ELECTROCARDIOGRAPHY SYST (K914206)Kardiosis Ltd. Co.1992-03-30
LIFE-AIR 1000 PATIENT WARMING COVERS (K914383)Progressive Dynamics, Inc.1992-03-30
GIKTER ECG CASSETTE TAPE RECORDER MODEL XR 300 (K921068)Datrix1992-03-30
CORDIS BIPAL 7 BIOPSY FORCEPS (K920289)Cordis Corp.1992-03-30
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