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Cardiovascular

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

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RecordFirmDate
PASSIVE PLUS ENDOCARDIAL PACING LEADS VAR. MODELS (K932892)Siemens-Pacesetter, Inc.1994-07-06
CARBOMEDICS(R) PROSTHETIC HEART VALVE HOLDER HANDLE (K942736)Carbomedics, Inc.1994-07-06
EXACTA PERCUTANEOUS INTRODUCER SHEATH (K941428)Ohmeda Medical1994-07-06
OMNI-CENTRAL STATION MONITOR (K936051)Invivo Research, Inc.1994-07-06
ADVANCE PRESSURE MONITOR/HIGH PRESSURE LINES (K911884)Advance Medical Designs, Inc.1994-07-05
VX4 RECORDING PULSE OXIMETER (K935510)Vitalog Monitoring,Inc.1994-07-01
HAND ANEROID SPHYGMOMANOMETER (K940493)Welch Allyn, Inc.1994-07-01
IMPULSE 4000 DEFIBRILLATOR/TRANSCUTANEOUS PACER ANALYZER (K941404)Hogan & Hartson1994-06-29
AVECOR PRE-BYPASS FILTER (K940126)Avecor Cardiovascular, Inc.1994-06-28
SCIMED TRIGUIDE GUIDING CATHETER (K941137)Scimed Life Systems, Inc.1994-06-22
ZIPPREP ELECTRODE (K940802)Aspect Medical Systems, Inc.1994-06-22
PULSE OXIMETER (K941289)Bci Intl., Inc.1994-06-22
620CSR DISPLAY DRIVER (K932894)Vidco, Inc.1994-06-20
HAND CONTROLLED SYRINGE (K942329)Abbott Laboratories1994-06-20
AFFINITY CVR (K936003)Avecor Cardiovascular, Inc.1994-06-20
PLATINUM PLUS GUIDEWIRE (K935997)Boston Scientific Corp1994-06-17
SILICONE BIPOLAR LEAD MODELS 1136T, 1142T &1146T (K930876)Siemens-Pacesetter, Inc.1994-06-15
PRESSURE MONITORING EXTENSION (K942482)Surgical Technologies, Inc.1994-06-14
DYE MANAGEMENT SYSTEM (K941254)Abbott Laboratories1994-06-13
SCHNEIDER GUIDEZILLA SOFTIP GUIDING CATHETER (K935292)Boston Scientific Scimed, Inc.1994-06-10
K-SNAP (K940586)Katecho, Inc.1994-06-09
LIFEPAK 300 AUTOMATIC ADVISORY DEFRILLATOR (K925936)Physio-Control Corp.1994-06-08
CATH-SEAL (K935077)Universal Medical Instrument Corp.1994-06-07
MODEL T131 MEMORY TRANSMITTER (K933021)Biometric Products, Inc.1994-06-06
MARINR SERIES EP DIAGNOSTIC CATHETERS (K931794)Medtronic Cardiorhythm1994-06-06
BARD(R) EXPANDED PTFE VASCULAR GRAFT (K940816)C.R. Bard, Inc.1994-06-02
CARDIOMETRICS FLOWIRE DOPPLER GUIDE WIRES (K941485)Cardio Metrics, Inc.1994-05-31
TRANSIT INFUSION CATHETER (K936260)Cordis Corp.1994-05-31
PLEXUS 2 & 3.5 HOLLOW FIBER OXYGENATORS (K931444)Sorin Biomedica, Fiat, USA, Inc.1994-05-27
SARNS ULTRASONIC AIR SENSOR (K940651)3M Health Care, Sarns1994-05-24
SWAN-GANZ CC0/SVO2 THERMODILUTION CATHETER (K940795)Baxter Edwards1994-05-24
SCIMED 0.014 PTCA GUIDE WIRE WITH ICE HYDROPHILIC COATING (K941895)Scimed Life Systems, Inc.1994-05-24
MEDICON INSTRUMENTS TROCARS, TROCAR SLEEVES AND REDUCTION SLEEVES (K936247)Medicon Instruments, Inc.1994-05-19
BURRON EXPEDITER BRAIDED BALLOON PTA CATHETER (K930745)B.Braun Medical, Inc.1994-05-19
GORE-TEX CARDIOVASCULAR PATCH (K940906)W. L. Gore & Associates, Inc.1994-05-18
AOR-TEX VASCULAR GRAFT (K933987)W. L. Gore & Associates, Inc.1994-05-17
HP M1175A, M1176A, COMPONENT MONITORING SYSTEM (K941811)Hewlett-Packard Co.1994-05-17
REUSABLE CW DOPPLER PROBES: MODELS P8M05S8A, P8M05N5A, & LCW-8 (K934638)Koven Technology, Inc.1994-05-13
WEDGE PRESSURE BALLOON CATHETER BY J-LLOYD (K935403)J-Lloyd Medical, Inc.1994-05-12
ONTRAC STEERABLE GUIDEWIRE (K941229)Lake Region Mfg., Inc.1994-05-12
ENDOSURG DISPOSABLE SECONDARY TROCAR (K940036)Endosurg1994-05-12
BIFURCATED LEAD ADAPTORS, 3.2MM & 5.0 MM (K934899)Telectronics Pacing Systems, Inc.1994-05-12
SCIMED 6 FRENCH ANGIOGRAPHIC CATHETER MODIFICATION (K934541)Scimed Life Systems, Inc.1994-05-12
AFFINITY VENOUS RESERVIOR BAG (K935717)Avecor Cardiovascular, Inc.1994-05-10
SCIMED 10 FR LARGE LUMEN TRIGUIDE-FLEX GUID CATH (K940545)Scimed Life Systems, Inc.1994-05-06
EP MEDICAL, INC. EP-3 CLINICAL STIMULATOR (K935590)Ep Medical, Inc.1994-05-05
520 DISPLAY DRIVER- STATUS I (K926298)Vidco, Inc.1994-05-04
DIASTAT(TM) VASCULAR ACCESS GRAFT/CLASS III (K940824)W. L. Gore & Associates, Inc.1994-05-04
MEDTRONIC GCIII CORONARY GUIDING CATHETER (K935738)Medtronics Interventional Vascular1994-05-04
ACS POWERBASE(TM) CORONARY GUIDING CATHETER (K940559)Advanced Cardiovascular Systems, Inc.1994-05-03
FLOW DIRECTED THERMODILUTION BALLOON CATHETER (K935404)J-Lloyd Medical, Inc.1994-05-03
MISCELLANEOUS PACING LEAD (K925168)Oscor Medical Corp.1994-05-03
DIASTAT VASCULAR ACCESS GRAFT (K940062)W. L. Gore & Associates, Inc.1994-05-02
MINIX/MINIX ST PULSE GENERATORS (K932884)Medtronic Vascular1994-05-02
MEDTRONIS(R) PACING LEADS AND LEAD ADAPTORS, MODIF (K933055)Medtronic Vascular1994-05-02
ANGIOGRAPHIC BALLOON CATHETER BY J-LLOYD (K935402)J-Lloyd Medical, Inc.1994-04-26
METRONIC BUCHBINDER ENVOY PERCUTANEOUS CATHETERS (K935425)Medtronics Interventional Vascular1994-04-26
MANUAL STETOSCOPE (K940578)Bhs Intl., Inc.1994-04-26
ZYMED HOLTER SCANNER MODEL 2010 (K930806)Agilent Technologies1994-04-25
SURGIPUMP (K935763)W.O.M. World of Medicine GmbH1994-04-21
INNERSENSE DISPOSABLE MICROTRANSDUCER (K941283)Becton Dickinson Vascular Access, Inc.1994-04-19
SCIMED 8 FRENCH TRIGUIDE GUIDING CATHETER (K940603)Scimed Life Systems, Inc.1994-04-19
MARQUETTE EAGLE MONITOR (K920790)Marquette Electronics, Inc.1994-04-19
NGBCD & NGBCDP CARDIOPLEGIA DELIVERY SYSTEMS (K934847)Sorin Biomedical, Inc.1994-04-15
SORIN BLOOD CARDIOPLEGIA SYSTEM (K934763)Sorin Biomedical, Inc.1994-04-15
ACS ROTATING HEMOSTATIC VALVE & ACS DUOSTAT ROTATING HEMOSTATIC VALVE (K934624)Advanced Cardiovascular Systems, Inc.1994-04-13
BIOCHEM MODEL 3302 NEWOX2 OXIMETER (K920083)Biochem International, Inc.1994-04-11
SOFTTOUCH GUIDE CATHETER (K934685)Mallinckrodt Medical1994-04-07
FUKUDA DENSHI MODEL HG-301 (K921454)Fukuda Denshi USA, Inc.1994-04-01
SCIMED 5, 7, AND 8 FRENCH ANGIOGRAPHIC CATHETERS (K934581)Scimed Life Systems, Inc.1994-03-31
CARDIOVASCULAR AND VASCULAR GUIDEWIRE MODIFICATIONS (K935170)Lake Region Mfg., Inc.1994-03-31
ENVOY GUIDING CATHETER (K940187)Cordis Neurovascular, Inc.1994-03-30
CARD GUARD MODEL CG-8000 (K926515)Card Guard Scientific Survival , Ltd.1994-03-30
MEDTRONIC INTERVENTIONAL VASCULAR Y-ADAPTER, TRI-ADAPTER, TRI-ADAPTER & ACCESSORY PACKS (K940063)Medtronics Interventional Vascular1994-03-29
UNIPOWERR RECHARGEABLE BATTERY PACK (K935111)Unipower Corp.1994-03-28
CRITIKIT PLUS IN LINE ROOM/ICE TEMPERATURE INJECTATE KIT (K936182)Ohmeda Medical1994-03-25
EXACTA-SPEZIAL (K925295)Rudolf Riester GmbH & Co. KG1994-03-25
CHECK VALVE (FITTING) (K933084)Merit Medical Systems, Inc.1994-03-23
EXTERNAL VEIN STRIPPER (K933498)Applied Medical Resources1994-03-23
DIAGNOSTIC INTRAVASCULAR CATHETER (K925813)Target Therapeutics1994-03-23
SORIN BCD ADVANCED PEDIATRIC BLOOD CARDIOPLEGIA SYSTEMS (K936183)Sorin Biomedical, Inc.1994-03-23
MEDTRONIC MODEL 5028 TARGET TIP, BIPOLAR, IMPLANTABLE, TINED, VENTRICULAR, TRANSVENOUS LEAD (K933731)Medtronic Vascular1994-03-21
HEARTLINE TRANSTELEPHONIC ECG RECEIVING CONSOLE (K930314)Aerotel, Ltd.1994-03-18
VITAL-COMBO(R) (K922315)Physio-Control Corp.1994-03-16
E-FAX REMOTE MONITOR (K932863)Coherent Systems, Inc.1994-03-16
PROTECTOR INTRODUCER SHEATH (K930808)Boston Scientific /International Technologies1994-03-15
TORQUE DEVICE (K936032)Merit Medical Systems, Inc.1994-03-15
OXISAT (K934091)Marquette Electronics, Inc.1994-03-15
HASKEL CPR (K922093)Haskel, Inc.1994-03-14
MXT-2 12 LEAD MICRO-TRANSMITTER (K933012)Medical Electronic Record Exchange1994-03-14
NONIN MEDICAL, INC. FINGER PHANTOM FOR PULSE OXIMETERS (K940463)Nonin Medical, Inc.1994-03-14
COMPUTER ASSISTED ARCHIVAL TECH. PHYSIOLOGY STAT. (K931900)Archival Technologies, Inc.1994-03-11
MICROTRACK (K935929)Devices For Vascular Intervention, Inc.1994-03-10
SCIMED ENTRE PTCA GUIDE WIRE WITH J-TIP (K935905)Scimed Life Systems, Inc.1994-03-10
VAS-CATH INC. OPTI-PLAST ANGIOPLASTY CATHETER (K925485)Vas-Cath, Inc.1994-03-10
CABOT MEDICAL NIAGRA-TRS THERMAL RETENTION SYSTEM (K940171)Cabot Medical Corp.1994-03-09
CORFAX CARDIAC DATA TRANSMITTER (K931585)Ralin Medical, Inc.1994-03-07
PROSCOPES AND ADSCOPES (K935944)American Diagnostic Corp.1994-03-03
VENOUS RESERVIOR/CARDIOTOMY AUTOTRANSFUSION FILTER WITH DURAFLO II HEPARIN TREATMENT (K933713)Baxter Healthcare Corp1994-03-01
MEDRAD CT CUSTOM CONVENIENCE KIT (K933908)Medrad, Inc.1994-02-25
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