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Cardiovascular

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

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RecordFirmDate
MEDTRONIC MODELS 59401 5941 (K823831)Medtronic Vascular1983-03-16
PACEMAKER ELECTRODE PERM. & TEMP (K830464)Daig Corp.1983-03-16
CATHETER CONNECTION W/INTEGRAL INJECTATE (K830523)Gould, Inc.1983-03-16
VARIOUS CARDIOVASCULAR PRODUCTS (K823357)C.R. Bard, Inc.1983-03-11
HOLDER FOR BOS-2S INFANT BUBBLE OXYGENA- (K830167)American Bentley1983-03-11
MICRO FITNESS COMPUTER (K830003)Microfit, Inc.1983-03-10
CYBERLITH IX QUANTUM-UNIPOLAR CARDIAC (K823863)Intermedics, Inc.1983-03-10
PATCH (K823345)Shiley, Inc.1983-03-10
TELEMETRY SYSTEM (K823906)Transkinetic Systems, Inc.1983-03-09
IL VIDEO 22,21 & II ATOMIC SPECTROPHOTO- (K830149)Instrumentation Laboratory CO1983-02-28
VEINPREP VEIN GRAFT PREP. KIT A277723 (K830150)Atrium Medical Corp.1983-02-28
POLYETHYLENE MONITORING CONNECTORS (K830420)Vertex Medical Corp.1983-02-28
LIFELINE UNIPOLAR J-LEAD #483-05 (K830463)Intermedics, Inc.1983-02-28
EPI CARDIA SYS. - AMBULATORY MONITOR (K830013)Medicomp, Inc.1983-02-28
CENTRAL VEIN CATHERIZATION KIT (K823758)Access Devices, Inc.1983-02-23
AFP SYSTEM PULSE GENERATOR MODEL 261/262 (K822639)Pacesetter Systems1983-02-18
IBM 588 DIGITAL ECG ACQUISITION/ANALYSIS (K830163)Intl. Business Machines1983-02-18
TRANSLUCENT POLY. CATH. CONNECTOR AND (K830237)Vertex Medical Corp.1983-02-18
COEURLOCK STERILE DISPOS. ANGIOGRAPHIC (K823920)Coeur Laboratories, Inc.1983-02-18
INTRA-AORTIC BALLOON SYSTEM (K823739)Smec, Inc.1983-02-18
USCI TEMP. ATRIO-VENTRICULAR ELECTRODE (K830094)C.R. Bard, Inc.1983-02-18
AFP PULSE GENERATOR (K823559)Pacesetter Systems1983-02-18
BEL BLOOD LEVEL DETECTOR (K823712)R. Scott Bell1983-02-07
USCI ELECTRONIC MANOMETER (K830093)C.R. Bard, Inc.1983-01-28
ARTERIAL BLOOD FILTER AF-1025-AF-1025BL (K830131)American Bentley1983-01-28
ARTERIAL BLOOD FILTER AF-1040-AF-1040BL (K830132)American Bentley1983-01-28
AUFRANC-TURNER ATS METAL BACKED ACETABU (K830097)Howmedica Corp.1983-01-28
INTRACATH-DA INTRAVENOUS CATH. PLACEMENT (K823064)Parke-Davis Co.1983-01-27
MODEL 78670A (K823268)Hewlett-Packard Co.1983-01-26
PERCOR INTRA-AORTIC BALLOON INSERTION (K823342)Datascope Corp.1983-01-24
SIDEARM Y-ADAPTOR (K823243)American Edwards Laboratories1983-01-21
ZEE SPHYGMOMANOMETER (K823501)Zee Medical Products Co., Inc.1983-01-21
SIRECUST 456 (K830028)Analogic Corp.1983-01-21
S.M.P. CONTRAST MEDIA SET (K830022)Omega Technologies, Inc.1983-01-21
MODEL SP5800 #8 FRENCH INTRO. KIT (K823262)Gould, Inc.1983-01-18
LIFELINE -UNIPOLAR LEAD #487-05 (K823508)Intermedics, Inc.1983-01-14
SWITCHING UNIT ELECTRODE CATHETERS (K823361)Webster Laboratories, Inc.1983-01-14
CLEAR CARDIOPLEJIA DELIVERY SYSTEM (K823451)3M Health Care, Sarns1983-01-14
ALTA II ECG RECORDER (K822362)Scole Engineering Co.1983-01-14
GORE-TES EXPANDED PTFE PATCH (K821717)W. L. Gore & Associates, Inc.1983-01-12
ELECTRODE LEAD OF SILICONE ELASTOMETER (K823452)Telectronics, Inc.1983-01-08
OXYGEN CONSUMPTION MONITOR #OCM-0100 (K823359)Bentley Laboratories, Inc.1983-01-05
CARDF (K823731)Shiley, Inc.1983-01-05
BOS-2S, SPIRAFLO BUBBLE INFANT OXYGEN. (K823273)Bentley Laboratories, Inc.1983-01-05
INJECTION FILL TUBE (K823238)Vetrex Medical Corp.1982-12-30
MON-A-THERM MYOCARDIAL TEMP. SENSOR (K823435)Burditt & Calkins-Siemens-Elema1982-12-30
VENOUS RESERVOIR BAG #BMR-1400 (K823272)Bentley Laboratories, Inc.1982-12-30
VERTEX MONITORING CATHETER (K823253)Vertex Medical Corp.1982-12-30
FUKUDA DENSHI 6-CHANNEL AUTO. ELECTRO- (K823584)Brentwood Instruments, Inc.1982-12-30
BACKSTOP VALVE W/SIDE ARM (K823190)Vertex Medical Corp.1982-12-30
ELECTROCARDIOGRAPH #334 (K823488)Birtcher Corp.1982-12-30
NEUROMEDICS PACETRON HEART RATE MONITOR (K823290)Intermedics, Inc.1982-12-30
MODEL 8300 TESTER (K823197)Medicon, Inc.1982-12-30
CLEAR VINYL MONITORING CONNECTOR (K823340)Vertex Medical Corp.1982-12-30
HOLTER KIT MODEL #5000 SERIES (K823414)Andover Medical, Inc.1982-12-30
ELECTRODE, PACEMAKER, PERMANENT (K823033)Pacesetter Systems1982-12-30
TUOHY-BORST ADAPTER W/SIDE ARM (K823192)Vertex Medical Corp.1982-12-30
REUSABLE METAL STOPCOCK (K823254)Vertex Medical Corp.1982-12-30
MODELS DPT 1000/DPT 1000NS (K823286)Bio-Med Corp.1982-12-30
HOLTER RECORDER & PLAYBACK/ANALYSIS SYS (K822818)Marquette Electronics, Inc.1982-12-30
OXYGENATORS #BOS-10, 105, 5S (K823456)Bentley Laboratories, Inc.1982-12-30
JACKET & SET (K823533)Shiley, Inc.1982-12-30
ULTRA-ASEPT ANGIOGRAPHIC SYRINGE/SPARE (K823256)Vertex Medical Corp.1982-12-30
DISPOSABLE PLASTIC STOPCOCK (K823191)Vertex Medical Corp.1982-12-30
FEP-RINGED GORE-TEX@ VASCULAR GRAFT (K821826)W. L. Gore & Associates, Inc.1982-12-29
DURAPULSE (K823371)Cpm International, Inc.1982-12-22
TELEMETRY DECODER #540-02 (K823678)Intermedics, Inc.1982-12-22
THERMAL DILUTION CATHETER (K823484)Instrumentation Laboratory CO1982-12-22
MODEL RM 6000, 6100,6200 POLYGRAPH (K823281)Nihon Kohden America, Inc.1982-12-22
EXTRACORPOREAL BLOOD GAS SYSTEM (K822000)Cardiovascular Devices, Inc.1982-12-22
DATASCOPE MODEL 83 IABP SYSTEM (K821951)Datascope Corp.1982-12-21
CARDIAC ELEVATOR (K823094)Cardio Surgical Research, Inc.1982-12-15
SEA MED MODEL 880 (K823048)Seamed Corp.1982-12-15
HTS *1 (K822843)Global Office Automation System, Inc.1982-12-15
INTRA CATH-DSA INTRAVENOUS CATH PLACE. (K823065)Parke-Davis Co.1982-12-15
MINGOGRAF 4, MINGO CARD 4 & MINOCARD 3 (K822978)Siemens Corp.1982-12-15
OXYGENATOR 10 (K823343)Gambro, Inc.1982-12-15
ELECTROCARDIOGRAPH INTERPRETER (K822968)Suzuken Co., Ltd.1982-12-15
CORATOMIC #VX5-105 & VX5-205 PULSE GEN. (K822791)Coratomic, Inc.1982-12-15
FULL-DISCLOSURE AMBULATORY ECG SYSTEM (K823529)Clinical Data, Inc.1982-12-15
SMEC BALLOON SYSTEM (K823177)Smec, Inc.1982-12-15
IMPLANTABLE PACING LEAD, TINED #3262 & (K823447)Vascular Products, Inc.1982-12-03
READY-BOX BODY-TEMP MEDIA WARMER MALLIN- (K823356)Forma Scientific, Inc.1982-12-03
IMPLANTABLE PACING LEAD TINED #3390 & (K823448)Oscor, Inc.1982-12-03
PRODUCTS IMPLANTABLE PACING LEAD,TINED (K823446)Oscor, Inc.1982-12-03
CADIO-RESPIRATORY MONITOR #CR-2 (K823312)Electromed Intl., Ltd.1982-11-30
MIKRO-TIP CATHETER PRESSURE TRANSDUCER (K823434)Millar Instruments, Inc.1982-11-30
MEDTRONIC MODELS 4011 & 4511 (K822781)Medtronic Vascular1982-11-30
INTERSEPT PEDIACTRIC EXTRACORPOREAL FILT (K823108)Extracorporeal Medical Specialities, Inc.1982-11-30
BALLOON THERMODILUTION CATHETER #7164& (K823433)Critikon Company, LLC1982-11-30
THE 500 MONITOR SERIES (K823052)Vitatek1982-11-30
INTERFACE CARDIOTOMY BLOOD FILTER #50 (K823259)Medical, Inc.1982-11-24
INTERFACE CARDIOTOMY BLOOD FILTER #51 (K823260)Medical, Inc.1982-11-24
MINGOCARD 7 & MINGOPHONE 7 (K822983)Siemens Corp.1982-11-24
MODEL 525 NEO-TRAK NEONATAL RECORDER (K823210)Ge Medical Systems Information Technologies1982-11-24
CAPIOX II (K823125)Terumo Medical Corp.1982-11-24
COSMOS (K823220)Nihon Kohden America, Inc.1982-11-24
LIFESCOPE II/FOUR (K823249)Nihon Kohden America, Inc.1982-11-24
MODEL 366-07 ADAPT AID LEAD ADAPTER (K822704)Intermedics, Inc.1982-11-24
INTERFACE ARTERIAL BLOOD FILTER #40 (K823258)Medical, Inc.1982-11-24
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