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Cardiovascular

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

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RecordFirmDate
DUALTHERM(R) CARDIAC OUTPUT COMPUTER (K925285)B. Braun of America, Inc.1993-07-21
MODIFIED MODEL M1403A TELEMETRY MONITORING SYSTEM (K920429)Hewlett-Packard Co.1993-07-20
CC ARHYTHMIS MONITORING OPTION (K923747)Hewlett-Packard Co.1993-07-20
CARDIAC OUTPUT PULMONARY ARTERY CATHETER & MONITOR (K925444)Ami-Med Corp.1993-07-19
SDI OXYGEN/DIGITAL OXYGEN TRANSDUCERS (DOT) (K920966)Aristo Medical Products, Inc.1993-07-16
PSG DIRECTIONAL HYDROPHILIC GUIDE WIRE (K931327)Peripheral Systems Group1993-07-14
HE-30 GOLD (K931967)Bentley Laboratories, Inc.1993-07-13
TROPIC-AIR (K923104)Seabrook Medical Systems, Inc.1993-07-13
CARDIO-PAK BASIC PUMP PACK (K923231)Cardio-Med-Associates, Inc.1993-07-09
LAPAROSCOPIC CHOLANGIOGRAPHY CATHETER KIT (K930787)Advanced Surgical, Inc.1993-07-09
BIO-PROBE(R) BLOOD FLOW MONITORING SYST(TX-50/50P) (K924208)Medtronic Bio-Medicus, Inc.1993-07-08
BP8800T/8000IR/8300G NON-INVASIVE BLOOD PRES. SYST (K921048)Colin Medical Instruments Corp.1993-07-01
CRITIKON VITAL SIGNS MODULE (K915697)Critikon Company, LLC1993-07-01
SCIMED TRANSPORT STEERABLE GUIDE WIRE AND ACCESS. (K931584)Scimed1993-07-01
SYSTEM 7110 NON-INVASIVE BLOOD PRESSURE MONITOR (K923595)Advanced Medical Instruments, Inc.1993-07-01
EL2-SERIES BLOOD COLLECTION REERVOIR (K930154)Electromedics, Inc.1993-07-01
ZEPHYR INFUSION CATHETER (K921247)Target Therapeutics1993-06-29
CVIS INSIGHT IMAGING CATHETER (K924922)Cardiovascular Imaging Systems, Inc.1993-06-29
CRI CYNOSAR CATHETER (K924227)Catheter Research C/O Burditt, Bowles & Radzius1993-06-29
BALT GUIDING CATHETER (K925632)Target Therapeutics1993-06-29
SCIMED(R) ENTRE(TM) II PTCA GUIDE WIRE & ACCESSORY (K931514)Scimed Life Systems, Inc.1993-06-25
DPD DEFIBRILLATOR (K930548)Medical Research Laboratories, Inc.1993-06-25
BALT INTRODUCER (K925633)Target Therapeutics1993-06-25
SCHNEIDER MAGNUM PERIPHERAL RECANALIZATION GUIDEWI (K931577)Schneider Intl., Ltd.1993-06-23
ESCORT 100/300 SERIES B PATIENT MONITORS (K930004)Medical Data Electronics1993-06-23
CORDIS 7 FRENCH THRULUMEN CATHETER (K922891)Cordis Corp.1993-06-23
SIGNATURE(TM) CUSTOM TUBING PACK (K924529)Avecor Cardiovascular, Inc.1993-06-23
INTERSEPT FILTERED CARDIOTOMY RESERVOIR (K926226)Medtronic Vascular1993-06-22
CARPENTIER-EDWARDS PHYSIO ANNULOPLASTY RING (K926138)Baxter Healthcare Corp1993-06-22
CARDIOMAGIC SOFTWARE (K925639)Instromedix, Inc.1993-06-22
POSSIS MEDICAL MYOPORE BIPOLAR SUTURELESS MYCARDIA (K925099)Possis Medical, Inc.1993-06-22
BARD(R) BLOOD CARDIOPLEGIA HEAT EXCHANGER/TUBE SET (K930299)C.R. Bard, Inc.1993-06-22
INSTANT MEMORY 2000 (K924187)Telescan Medical Systems1993-06-16
SCIMED ENCORE(TM) ADVANTAGE KIT/ESSENTIALS KIT (K925608)Scimed Life Systems, Inc.1993-06-16
MODEL 1148T TRANSVENOUS, SCREW-IN LEAD (K925347)Siemens-Pacesetter, Inc.1993-06-10
TERUMO CORONARY GUIDE WIRE (K925852)Terumo Medical Corp.1993-06-10
SARNS TURBO MEMBRANE OXYGENA. W/INT. CARDIOTOMY R. (K925076)3M Health Care, Sarns1993-06-07
SCHNEIDER SOFTIP SST ANGIOGRAPHIC (DIAG) CATHETER (K926003)Schneider Intl., Ltd.1993-06-07
PLEXUS PULSER I, PLEXUS PULSER II (K924891)Dobre, Inc.1993-06-07
SCHNEIDER MATCH-35 PERCUTANEOUS TRANSLUMINAL ANGIO (K926271)Schneider Intl., Ltd.1993-06-07
SARNS TURBO MEMBRANE OXYGENA. W/INT. RESERVOIR (K925075)3M Health Care, Sarns1993-06-07
DOC-TITE(TM) GUIDE WIRE EXTENSION (K931171)Advanced Cardiovascular Systems, Inc.1993-06-04
CARDIO2 CYCLE (K926233)Ergometrix, Inc.1993-06-04
MEDTRONIC BIO-MEDICUS HANDCRANK MODEL 150 (K926357)Medtronic Bio-Medicus, Inc.1993-06-02
CVIS LONGVIEW (K930311)Cardiovascular Imaging Systems, Inc.1993-06-02
DUAL LUMEN L-CATH CATHETER SYSTEM (K925979)Luther Medical Products, Inc.1993-05-27
CORDIS NIHON CATHETER SHEATH INTRODUCER (K931102)Cordis Corp.1993-05-27
CLEANCUFF(TM) (K931087)Med-Con, Inc.1993-05-27
ATRIUM'S HYBRID PTFE (K925123)Atrium Medical Corp.1993-05-27
HEMASHIELD MICROVEL/WOVEN DOUBLE VELOUR FABRIC (K931386)Meadox Medicals, Div. Boston Scientific Corp.1993-05-27
NELLCOR PORTABLE PULSE OXIMETER MODEL N-20 (K915699)Nellcor, Inc.1993-05-27
NEW LEAD INTRODUCER KITS, VARIOUS MODELS (K926340)Telectronics Pacing Systems, Inc.1993-05-27
URESIL VALVE CUTTER WITH INTERCHANGEABLE HEADS (K930011)Uresil Corp.1993-05-26
BIOCHEM 9100 MULTIGAS MONITOR IBP MODULE (K921388)Biochem International, Inc.1993-05-26
CATHETER GUIDEWIRE (PERIPHERAL USE) (K930961)Target Therapeutics1993-05-26
CRI ELECTRONIC CONTROL SYSTEM (K924125)Catheter Research C/O Burditt, Bowles & Radzius1993-05-26
SELECTIVE INFUSION II CATHETER (K914751)Advanced Cardiovascular Systems, Inc.1993-05-24
SARNS RETROGRADE CANNULA (K925442)3M Health Care, Sarns1993-05-21
AMBULATORY BLOOD PRESSURE MONITOR, MDL# 5100-01 (K925899)Welch Allyn, Inc.1993-05-21
ACCEMT DG(TM) BALLOON ANGIOPLASTY CATH, MODIFIED (K924358)Cook, Inc.1993-05-20
CARDIOPULMONARY BYPASS LEVEL SENSING MONITOR (K910599)Jtl Medical Corp.1993-05-20
MEADOX(R) SURGIMED OLBERT CATHETER SYSTEM(R) (K921706)Meadox Medicals, Div. Boston Scientific Corp.1993-05-20
MAVERICK PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY CAT (K925945)Scimed Life Systems, Inc.1993-05-20
EXTERNAL DEMAND PACEMAKER (K923621)Oscor Medical Corp.1993-05-19
STOCKERT CAPS1 CARDIOPLEGIC CONTROL MODULE (K925661)Sorin Biomedica, Fiat, USA, Inc.1993-05-18
LIFEPAK 10 DEFIBRILLATOR/MONITOR W/OPT PACEMAKER (K931053)Physio-Control Corp.1993-05-18
LV-20 VOLUMETER, 20 MHZ DOPPLER BLOOD FLOW METER (K922034)Titronics Medical Instruments, Inc.1993-05-18
ANTEGRADE/RETROGRADE CARDIOPLEGIA VALVE SYSTEMS (K922840)Gish Biomedical, Inc.1993-05-17
CCS MAESTRO II SERIES 200 CARDIAC PACEMAKER (K923868)Cardiac Control Systems, Inc.1993-05-14
MEDTRONIC MINIX & MINIX ST PULSE GENERATORS (K930770)Medtronic Vascular1993-05-14
OMRON OSCILLOMETRIC DIGITAL BLOOD PRESSURE MONIT. (K930798)Omron Healthcare, Inc.1993-05-13
CARDIOTOMY RESERVOIR W/20 MICRON FILITER (K920178)Lifestream Int'L, Inc.1993-05-13
SYSTEM 7500 NIBP/SA02 (K924910)Advanced Medical Instruments, Inc.1993-05-13
BARD WILLIAM HARVEY TWO STAGE CANNULA (K930684)C.R. Bard, Inc.1993-05-11
COBE CMS-HF HOLLOW FIBER MEMBRANE OXYGENATOR (K923272)Cobe Laboratories, Inc.1993-05-11
MODIFICATION OF SARNS TWO STAGE VENOUS CANNULA (K920902)3M Health Care, Sarns1993-05-11
MODEL 3500 MR-COMPATIBLE PULSE OXIMETER (K924285)Magnetic Resonance Equipment Corp.1993-05-11
MEDTRONIC BIO-MEDICUS BIO-CONSOLE MODEL 540E (K924206)Medtronic Bio-Medicus, Inc.1993-05-07
SIEMENS SIRECUST 700 BEDSIDES/ACCESSORIES, MODIFI (K921930)Siemens Medical Electronics1993-05-07
CALF GARMENT DVT10(S) COMPRESSIBLE LIMB SLEEVE (K925717)Huntleigh Healthcare, Inc.1993-05-07
BARD(R) WILLIAM HARVEY(R) ARTERIAL STRAIGH CANNULA (K930620)C.R. Bard, Inc.1993-05-07
MODEL 320 MR-COMPATIBLE PULSE OXIMETER (K924282)Magnetic Resonance Equipment Corp.1993-05-07
CORDIS 9 F GUIDING CATHETER (K925131)Cordis Corp.1993-05-06
BARD WILLIAM HARVEY AORTIC ROOT CARDIOPLEGIA CANNU (K930593)C.R. Bard, Inc.1993-05-06
MEDTRONIC BIO-MEDICUS BIO-CONSOLE MODEL 550 (K924205)Medtronic Bio-Medicus, Inc.1993-05-06
MEDTRONIC INTERVENTIONAL VASCULAR SHERPA GUIDEWIRE (K925342)Medtronics Interventional Vascular1993-05-06
EP AMP, MODEL #901 (K925346)Quinton Electrophysiology Corp.1993-04-30
BALANCED(TM) NYLON BLADDER (K930604)Pymah Corp.1993-04-30
ITC CATHETERS W/ HYDROMER (K922609)Interventional Therapeutics Corp.1993-04-30
CARDIFIX ENDOCARDIAL PACING LEAD (K922042)Intermedics, Inc.1993-04-29
AMPLATZ GUIDEWIRES (K930622)Meadox Medicals, Div. Boston Scientific Corp.1993-04-29
MORTARA INSTRUMENT, INC. E-SCRIBE (K930558)Mortara Instrument, Inc.1993-04-27
THE ACTA FORMULA (K922703)Biosound, Inc.1993-04-27
SYSTEM 97 (K922235)Datascope Corp.1993-04-27
ARROW FISCHELL KINK RESIST PERCUT SHEATH INTRO SET (K924607)Arrow Intl., Inc.1993-04-22
NYLEX CATHETERS (K930479)Cordis Corp.1993-04-21
PLEUR-EVAC CARDIOTOMY RESERVOIR (K925046)Deknatel, Inc.1993-04-20
TRACET T-6000 (K930258)Lectec Corp.1993-04-16
K-DEFIB/PACE CARBON ELECTRODE (K926175)Katecho, Inc.1993-04-15
9055 IRCA OPTION FOR SYSTEM ATHENA 9050 NT (K930134)S & W Medico Teknik1993-04-09
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