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Cardiovascular

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

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RecordFirmDate
ADVANCE LASER FLOWMETER, ALF 21 (K903633)Transonic Systems, Inc.1990-10-09
RTM 36-05, 60-05, RTD 36-05, 60-05 RADIO. LEADWIRE (K901780)Medtronic Vascular1990-10-09
MODEL 9444 TELETRACE II ECG MONITORING SYSTEM (K903960)Medtronic Vascular1990-10-09
LIQUID DETECTOR (K903495)Life-Tech Intl., Inc.1990-10-05
RSI FEMORAL GUIDING CATHETER (K902943)Retroperfusion Systems, Inc.1990-10-03
THE OPHTHIMUS SYSTEM (K896017)Hightech Vision1990-10-02
SOFTOUCH GUIDING CATHETER (K902953)Mallinckrodt Medical1990-09-28
GUIDEWIRE TORQUE DEVICE AND GUIDEWIRE INTRODUCER (K903606)North American Instrument Corp.1990-09-27
MODIFIED HEARTSTART DEFIBRILLATION ELECTRODE (K902429)Laerdal Mfg. Corp.1990-09-27
MODIFICATION TYPE 9266 SA02 SYSTEM ATHENA (K902779)S & W Medico Teknik1990-09-27
SITERITE NEEDLE GUIDE (K903158)Dymax Corp1990-09-27
BARD FILTERED CARDIOTOMY RESERVOIR (K902856)C.R. Bard, Inc.1990-09-27
ROADRUNNER WIRE GUIDE (K901899)Cook, Inc.1990-09-27
RESUBMITTED MULTIORGAN PERFUSION CANNULA (K902394)Fresenius USA, Inc.1990-09-27
MEDRAD MARK V-PLUS INJECTOR (K903390)Medrad, Inc.1990-09-26
PERCUTANEOUS INTRODUCER SET (K902275)Thomas Medical Products, Inc.1990-09-26
PERCUTANEOUS CATHETER INTRODUCER KIT (K903906)Intec Medical, Inc.1990-09-26
SCHNEIDER MONORAIL(TM) SOFTRAC-PTA(TM) CATHETER (K902091)Schneider Intl., Ltd.1990-09-26
MODELS 5069/5071 MYOCARDIAL PACING LEADS (K902002)Medtronic Vascular1990-09-26
PERCOR STAT DL 8.5 FR 40CC IAB ONLY/LABELING CHANG (K902057)Datascope Corp.1990-09-25
TRANSESOPHAGEAL PROBE HOLDER & DISINFECTING COLUMN (K903414)Echo Ultrasound1990-09-19
NEOS (TM) 02 B PULSE GENERATOR (K903081)Biotronik, GmbH & Co.1990-09-14
GOLD GATORS (K903729)Lead-Lok, Inc.1990-09-14
CRI CYNOSAR CATHETER (K900320)Catheter Research C/O Burditt, Bowles & Radzius1990-09-14
ROTABLATOR (K901206)Heart Technology, Inc.1990-09-14
9.5F PERCU DOUBLE LUMEN INTRA-AORTIC BALLOON (K892222)Kontron Instruments, Inc.1990-09-14
PERSONAL 120/210 BASIC ELECTROCARDIOGRAPH (K902368)Esaote Biomedica Spa1990-09-11
OXIMETRY PROBE CATHETERS (K901736)Baxter Healthcare Corp1990-09-11
FUKUDA DENSHI MODEL FCP-2201 MODIFICATION (K903704)Fukuda Denshi USA, Inc.1990-09-07
AXILLOBIFEMORAL GORE-TEX VASCULAR GRAFT (K901641)W. L. Gore & Associates, Inc.1990-09-05
(PBS) PORTABLE BYPASS SYSTEM, MODEL 1000 (K901253)Bio Medicus, Inc.1990-09-05
BIOCHEM 6100 NON-INVASIVE MONITOR (K903222)Biochem International, Inc.1990-09-04
.018 HI-TORQUE FLOPPY GUIDE WIRE W/ PRESHAPED TIP (K902755)Advanced Cardiovascular Systems, Inc.1990-09-04
ELECTRO BLUE ECG ELECTRODE-PEDIATRIC CLOTH (K902738)Labeltape Meditect, Inc.1990-09-04
COOK CORONARY GUIDING CATHETER (K902905)Cook, Inc.1990-09-04
ADD'L TRANSDUCER FOR USE W/EUB-565 ULTRASOUND (K901657)Hitachi Medical Corp. of America1990-09-04
PE ELECTROPHYSIOLOGY LAB SYSTEM (PEEP) (K902716)Prucka Engineering, Inc.1990-09-04
ADD'L TRANSDUCER FOR USE W/EUB-165 ULTRASOUND (K901658)Hitachi Medical Corp. of America1990-09-04
SILVER MACTRODE (K902176)Marquette Electronics, Inc.1990-09-04
MODEL 610 MODIFIED (K903657)First Medical Devices Corp.1990-09-04
CATHSCANNER(R) PTA BALLOON DILATATION CATHETER (K902454)Endosonics Corp.1990-08-30
CLEARVIEW(TM) ANGIOSCOPIC IRRIGATION PUMP (K902444)Intramed Laboratories, Inc.1990-08-30
VITALMAX 500 PULSE OXIMETER W/TEMP. AND RESPIRA. (K901066)Pace Tech, Inc.1990-08-28
WORKSTATION FEMORAL INTRAVASCULAR RETRIEVAL SET (K902477)Medical Engineering and Development Institute1990-08-24
BP50 BLOOD PRESSURE AND PULSE MONITOR (K901392)Pulse Time Products, Ltd.1990-08-23
MORTARA INSTRUMENT MODEL ELI 50 (K902652)Mortara Instrument, Inc.1990-08-23
MODEL MSC SA02-5000 PULSE OXIMETER (K902192)Medical Systems Corp.1990-08-23
INTRODUCER, PERCUTANEOUS (K900658)Novoste Puerto Rico, Inc.1990-08-23
A1-A,A1-B,A1-ABP,A1-MBP,A1-Z,A6-A,A6-B,PEH PACE. (K902889)Biotronik, GmbH & Co.1990-08-23
MODELS 6207/6208/6209/6210/6211/6212/6214 (PLI'S) (K900515)Medtronic Vascular1990-08-23
CARDIOVISTA (K902486)Cardionostics, Inc.1990-08-23
MODELS 706 ECG/PRESSURE/RESP./SAO2, 705 ECG/RESP. (K901504)Ivy Biomedical Systems, Inc.1990-08-23
BYRD DILATOR SHEATH SET - TEFLON (K902469)Medical Engineering and Development Institute1990-08-23
COBE SATURATION/HEMATOCRIT MONITOR W/ FIBER OPTIC (K902758)Cobe Laboratories, Inc.1990-08-23
ARIES TAPERSEAL(TM) SHEATH (K903442)Aries Medical, Inc.1990-08-23
MORSE DT MANIFOLD (K902472)North American Instrument Corp.1990-08-23
OSCILLOMETRIC PULSE DETECTION DEVICE (K902453)Thomas J. Fogarty, M.D.1990-08-23
MCR4000 & MCR4000F CARDIOTOMY RESERVOIR (K902355)Medtronic Vascular1990-08-23
MANAN ARTERIAL CATHETER NEEDLE (K900978)Manan Medical Products, Inc.1990-08-23
CENTRALSCOPE 12 (K901072)Marquette Electronics, Inc.1990-08-23
FUKUDA DENSHI MODEL FX-3101 (K901817)Fukuda Denshi USA, Inc.1990-08-23
PERCOR STAT-DL 8.5 FR INTRA-AORTIC BALLOON (K896497)Datascope Corp.1990-08-17
ANTEGRADE/RETROGRADE Y W/INTEGRAL SELECTOR SWIT. (K900994)Dlp, Inc.1990-08-15
ITC ANGIOGRAPHIC CATHETER (K900757)Interventional Therapeutics Corp.1990-08-14
PERFUSION MONITOR (K900860)Cardio Metrics, Inc.1990-08-14
BAIR HUGGER(R) PATIENT WARMING SYSTEM-MODIFICATION (K903360)Augustine Medical, Inc.1990-08-14
BARD EXTRACORPOREAL CIRCULATION CANNULAE (K902277)C.R. Bard, Inc.1990-08-14
TYPE 9293 INTERFACE PULSEOX (K896738)S & W Medico Teknik1990-08-14
INTERVENTIONAL MEDICAL Y ADAPTER W/ADJUST. VALVE (K900998)Intec Medical, Inc.1990-08-14
ALOKA UST-5514DTU-7.5 LINEAR DOPPLER TRANSDUCER (K901335)Ge Medical Systems Information Technologies1990-08-10
ACS .010 HI-TORQUE INTER. AND STANDARD GUIDE WIRE (K902207)Advanced Cardiovascular Systems, Inc.1990-08-08
ITC INTRODUCER CATHETER (K900756)Interventional Therapeutics Corp.1990-08-08
BIOTRONIK'S PS-ENDOCARDIAL LEADS (K896824)Biotronik, GmbH & Co.1990-08-08
LASERDISH POLYURETHANE VENTRICULAR LEAD W/TRAILING (K900645)Telectronics Pacing Systems, Inc.1990-08-08
MODIFIED ANGIOGRAPHIC INJECTOR AND SYRINGE (K902221)Mallinckrodt Group, Inc.1990-08-08
MODIFIED SOFTWARE TO THE SONOS 100 ULTRASOUND (K902088)Hewlett-Packard Co.1990-08-08
PHANTOM RADIOTRANSLUCENT ECG MONITORING ELECTRODE (K900682)Contour Electrodes, Inc.1990-07-31
MOVABLE CORE GUIDEWIRE (K902152)Guidewire Technologies, Inc.1990-07-31
NF-50-E DISPOSABLE ECG ELECTRODE (K902407)Medicotest, Inc.1990-07-31
APPLICARD (EKG) (K900459)Medi-Globe Corp.1990-07-31
TEFLON COATED GUIDEWIRE (K902153)Guidewire Technologies, Inc.1990-07-31
TRI ADAPTER W/ADJUSTABLE HEMOSTASIS VALVES (K901247)Intec Medical, Inc.1990-07-31
SUBCLAVIAN INTRODUCER SET (K902251)Infusaid Corp.1990-07-31
EPICARDIA 4000 (K900207)Medicomp, Inc.1990-07-31
HEWLETT-PACKARD SERIES OF DISPOSABLE NIBP CUFFS (K901252)Hewlett-Packard Co.1990-07-31
SPBC SERIES SINGLE PASS BLOOD CARDIOPLEGIA SYSTEM (K896807)Gish Biomedical, Inc.1990-07-31
ZAP-GUARD (K896985)Guardian Angel Products, Inc.1990-07-31
ESCORT MODEL 400T TELEMETRY ECG MONITOR (K902254)Medical Data Electronics1990-07-27
EM-SCAN HP-2 PEDIATRIC BODY COMPOSITION ANALYZER (K902042)Em-Scan, Inc.1990-07-26
MODELS 4201, 4231 & 4235 EXTENSION CABLES (K902679)Pace Medical1990-07-19
ISOFLO(TM) HIGH PRESSURE INJECTION LINES (K901382)Healthdyne Cardiovascular, Inc.1990-07-19
DISPOSABLE COURNAND, SELDINGER & ONE-WALL NEEDLES (K900664)Sterimed, Inc.1990-07-18
PAG MICROPROCESSOR-CONTROLLED MODULE (K900365)Life Sciences Manufacturing, Inc.1990-07-18
MODEL 78834C NEONATAL PULSE OXIMETER (SAO2) (K901819)Hewlett-Packard Co.1990-07-18
THREADED PADDLE PAIRS, INTERNAL ADULT PEDI INFANT (K902590)Marquette Electronics, Inc.1990-07-18
CWD/PPG MODULE (K896500)Life Sciences Manufacturing, Inc.1990-07-18
RED DOT 2269 INFANT MONITORING ELECTRODE (K902080)3M Company1990-07-18
MODEL 1730 NEOTRODE WITH ATTACHED LEADWIRE (K901555)Medtronic Vascular1990-07-18
VITALMAX 800 NON-INVASIVE VITAL SIGN MONITOR/PULSE (K900451)Pace Tech, Inc.1990-07-18
LEOCOR CORFLO(TM) PUMP (K900350)Leocor, Inc.1990-07-17
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