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Cardiovascular

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

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RecordFirmDate
ATRAUMAX SURGICAL CLAMP (K950492)Applied Medical Resources1995-05-08
LARGE TIP (4MM) DIAGNOSTIC-ELECTROHYSIOLOGY CATHETERS (K951744)Boston Scientific Corp1995-05-04
KENEX INJECTOR HEAD SUPPORT (AS EXHIBIT 2) (K951005)Kenex , Ltd.1995-05-04
CVD BULLETT HI-FLO INFUSION CATHETER (K951503)Cardiovascular Dynamics, Inc.1995-05-04
ECHOMARK(R) ELECTROPHYSIOLOGY CATHETER (K933417)Echocath, Inc.1995-05-04
PACETRAK (K943123)Universal Medical, Inc.1995-05-03
HEARTRAK (K943124)Universal Medical, Inc.1995-05-03
CCS MAESTRO(R) II SERIES 200 MODELS 235 AND 227 CARDIAC PACEMAKER (K950210)Cardiac Control Systems, Inc.1995-05-03
SCIMED SCEPTOR PTCA GUIDE WIRE (K950534)Scimed Life Systems, Inc.1995-04-28
PRECEDER GUIDEWIRE (K950352)Boston Scientific Corp1995-04-28
CG-1000 PERSONAL ECG TRANSMITTER (K935909)Card Guard Scientific Survival , Ltd.1995-04-28
HEAT EXCHANGER MODIFICATION FOR DUO AND OPTIMA (K944267)Cobe Cardiovascular, Inc.1995-04-28
SIMON NITINOL FILTER (K944353)Nitinol Medical Technologies, Inc.1995-04-28
SCIMED SCEPTOR EXCHANGE GUIDE WIRE (K950535)Scimed Life Systems, Inc.1995-04-28
CORDIS INTRODUCING CATHETER (K945524)Cordis Corp.1995-04-26
NOPROFILE OLBERT CATHETER SYSTEM (K944989)Meadox Medicals, Div. Boston Scientific Corp.1995-04-26
OMNI-TRAC MODIFICATION (K935020)Invivo Research, Inc.1995-04-26
HEART RATE VARIABILITY SOFTWARE OPTION (K950779)Spacelabs, Inc.1995-04-25
MARQUETTE DEFIB ELECTRODE (K941262)Marquette Electronics, Inc.1995-04-20
OPEN TIP MULTI-ELECTRODE CATHETER, MODIFICATION (K933451)Electro-Catheter Corp.1995-04-19
KAPLAN-SIMPSON INFUSASLEEVE CATHETER (K950615)Localmed, Inc.1995-04-19
TIP DEFLECTOR (GENESIS) (K943257)Electro-Catheter Corp.1995-04-19
CLOSED TIP MULTI-ELECTRODE CATHETER, MODIFICATION (K933450)Electro-Catheter Corp.1995-04-19
HOLTER FOR WINDOWS (K930564)North East Monitoring, Inc.1995-04-19
SCIMED(R) COURIER GUIDE CATHETER (K946272)Scimed Peripheral Interventions1995-04-17
SCIMED(R) CHOICE(TM) PT EXCHANGE PTCA GUIDE WIRE (K950266)Scimed Life Systems, Inc.1995-04-14
CORDIS STEERABLE GUIDEWIRES (K950316)Cordis Corp.1995-04-14
GEMSCOM SERIES 6000, MODELS 6100, 6200 & 6300 (K940009)General Devices1995-04-14
ARBO DIAGNOSTIC ECG PATIENT CABLES & LEADWIRES ARBO SHIELDED MULTI-LEAD CABLE & LEAD SYSTEM (K940323)Arbo Medical, Inc.1995-04-12
BRAEMAR MODEL DL700 AMBULATORY ELECTROCARDIOGRAPHIC RECORDER (K945130)Braemar Corp.1995-04-12
MERCURY (K940081)Mennen Medical, Inc.1995-04-12
DASHER-14 (K950069)Target Therapeutics1995-04-12
SC 6000/ SC 6000P/ R50 (K944350)Siemens Medical Solutions USA, Inc.1995-04-10
SIEMENS SIRECUST 700 BEDSIDE MONITOR MODIFICATIONS (K933177)Siemens Medical Solutions USA, Inc.1995-04-10
SIEMENS CLINICAL WORK STATION (K935043)Siemens Medical Electronics1995-04-07
ARBO H85V/H87V/H27V DISPOS MONIT ELECTRODES (K935437)Arbo Medical, Inc.1995-04-06
BSC/CA MODEL 940 IAB (K940298)Boston Scientific Corp1995-04-06
IS-1/QUADRIPOLAR TERMINAL CAP, PART NUMBER 6011069 (K950140)Pacesetter, Inc.1995-04-06
QUEST CORONARY SINUS PERFUSION CANNULA -FRCC (K941916)Quest Medical, Inc.1995-04-06
TELEPHONE ELECTROCARDIOGRAPH TRANSMITTER (K934975)Rlt Medical Assoc., Inc.1995-04-06
SCHNEIDER GEX(TM) .014/.018 GUIDEWIRE EXCHANGE CATHETER (K950047)Isomedix Operations, Inc.1995-04-05
MEDTRONIC(R) 8.2 FRENCH SHERPA(R) SUPER PEAK FLOW(TM) CORONARY GUIDING CATHETER (K950026)Medtronics Interventional Vascular1995-04-05
SCIMED 6 FRENCH EXPO ANGIOGRAPHIC CATHETER (K950731)Scimed Life Systems, Inc.1995-04-05
ACS HI-TORQUE EXTRA S'PORT(TM) GUIDE WIRE (K950156)Advanced Cardiovascular Systems, Inc.1995-04-05
NOVATRANS II (K951129)Medex, Inc.1995-04-05
CARRYALL ENHANCEMENTS (K943931)Instromedix, Inc.1995-04-04
M-PATH NITINOL GUIDEWIRE (K946356)Microvena Corp.1995-03-31
SCIMED(R) CHOICE(TM) PTCA GUIDE WIRE (K950141)Scimed Life Systems, Inc.1995-03-31
SCIMED(R) CHICE(TM) EXCHANGE PTCA GUIDE WIRE (K950113)Scimed Life Systems, Inc.1995-03-31
BAXTER REINFORCED EXPANDED PTFE STEPPED VASCULAR GRAFT (K944844)Baxter Healthcare Corp1995-03-31
SCIMED(R) SCEPTOR(TM) PTCA GUIDE WIRE (K946240)Scimed Life Systems, Inc.1995-03-31
JOSTRA HL-15 MODULAR HEART-LUNG MACHINE (HEREINAFTER CALLED THE HL-15 OR THE DEVICE (K945720)Jostra Bentley1995-03-29
CORDIS AVANTI CATHETER SHEATH INTRODUCER (K945616)Cordis Corp.1995-03-29
PULSE OXIMETER MODEL 305 (K943842)Palco Laboratories, Inc.1995-03-24
PRESSSION S III (K942796)Chattanooga Group, Inc.1995-03-24
9.5 FR SENSATION DL INTRA-AORTIC BALLON CATHETER (K943919)Boston Scientific Corp1995-03-23
SIEMENS 1481 T TRANSMITTER, ENHANCED (K945037)Siemens Medical Solutions USA, Inc.1995-03-21
SCIMED(R) ENTRE PTCA GUIDE WIRE (K946180)Scimed Life Systems, Inc.1995-03-17
LOW PRESSURE INJECTION TUBING, COILED LINE, EXTENSION TUBING (K942381)Apogee, Inc.1995-03-17
3301T OXITEMP (K946185)Bci Intl., Inc.1995-03-17
CARDIOVIT AT-1, P-80 (K946205)Schiller America, Inc.1995-03-16
INTERMEDICS TRIANGLE CHEST PROBE MODEL 526-04 (K933278)Intermedics, Inc.1995-03-15
MEDIFRIEND PROFESSIONAL SPHYGMOMANOMETER (K950778)Shanghai Medifriend Medical Products Co., Ltd.1995-03-14
SCIMED(R) TRIDUIGE(R) GUIDE CATHETERS (K946204)Scimed Life Systems, Inc.1995-03-13
ZOLL PD 1600 SEMI-AUTOMATIC EXTERNAL DEFIBRILLATOR (K942344)Zoll Medical Corp1995-03-13
FLUORO-TIP(R) HEMOSTASIS VALVE INTRODUCER SET (K945396)B.Braun Medical, Inc.1995-03-13
PULSE HEART RATE MONITOR (K943243)Sensor Dynamics, Inc.1995-03-10
PRO-SPORT HEART RATE MONITOR (K943242)Sensor Dynamics, Inc.1995-03-10
NELLCOR SYMPHONY(TM) N-3100 BLOOD PRESSURE MONITOR AND CONNECTED TO THE NELLCOR SYMPHONY(TM) N-3000 PULSE OXIMETER (K945947)Nellcor, Inc.1995-03-08
IMD PSD 410 PACEMAKER TRANSMITTER (K943995)Integrated Medical Devices, Inc.1995-03-07
CONTROL (K944284)Daig Corp.1995-03-03
SHERPA SHERPA II AND ASCENT CORONARY GUIDING CATHETERS (K944668)Medtronics Interventional Vascular1995-03-03
SCIMED CHIOCE PLUS PTCA GUIDE WIRE (K945129)Scimed Life Systems, Inc.1995-03-03
SCIMED 6 FRENCH MICRO-MAX(TM) GUIDE CATHETER (K950094)Scimed Life Systems, Inc.1995-03-03
RMI CIRKUIT-GUARD(TM) PRESSURE RELIEF VALVE (K945931)Research Industries Corp.1995-03-03
POWERFLEX(TM) 5F PTA BALLOON CATHETER (K946052)Cordis Corp.1995-03-03
EK-VIEW(TM) ECG MANAGEMENT SYSTEM (K946115)Apcot Medical Systems1995-03-01
DINAMAP VITAL SIGNS MONITOR MODELS 9300 AND 9320/9340 (K942700)Critikon Company, LLC1995-03-01
CANDELA SHEATH SETS (K950634)Candela Laser Corp.1995-03-01
CANDEKA DUKATIR SETS (K950635)Candela Laser Corp.1995-03-01
SILICORE SEMI-FLOATER (K934787)Electro-Catheter Corp.1995-02-24
ACS GUIDE WIRES WITH MODIFIED PACKAGE INSERT (K946029)Advanced Cardiovascular Systems, Inc.1995-02-24
EKG VEST (K932903)Cardiotronics, Inc.1995-02-24
CVD PERIFLOW(TM) BALLOON DILATATION CATHETER (K945943)Cardio-Dynamics, Inc.1995-02-24
DATASCOPE 95 AND 97 IAB PUMP CONSOLE (K942454)Datascope Corp.1995-02-24
VASOGENICS EECP-MC2 (K940264)Vasogenics, Inc.1995-02-23
INTERGRATED MONITORING ARCHIVING AND COMMUNICATIONS SYSTEMS (IMACS) (K941762)Hogan & Hartson1995-02-22
CVPRO CARDIOVASCULAR PATCH (K943736)W. L. Gore & Associates, Inc.1995-02-22
INTRODUCER NEEDLE (SEVERAL SIZES) (K933522)Mediziv Medical Products 1987 , Ltd.1995-02-21
MEDSAT OXYGEN SATURATION SYSTEM (K941922)Medtronic Bio-Medicus, Inc.1995-02-17
HEWLETT-PACKARD M1021A MIX VEN OXY SAT PLUG-IN MODULE (K942842)Hewlett-Packard GmbH1995-02-16
PANASONIC WRIST BLOOD PRESSURE METER (K942422)King & Spalding1995-02-15
NAIS WRIST BLOOD PRESSURE METER (K942423)King & Spalding1995-02-15
SONAMET BODY COMPOSITION ANALYZER (K924972)Life Measurement Instruments, Inc.1995-02-13
REDIFURL AND TEPERSEAL DL INTRA-AORTIC BALLOON CATHETERS WITH HYDROMER COATING (K935184)St. Jude Medical, Inc.1995-02-10
ZOLL POWERBASE(TM) (K942850)Zoll Medical Corp1995-02-10
MONARCH AP(TM) (K943597)Merit Medical Systems, Inc.1995-02-10
BAXTER HANDLE MODEL 1150 (K944214)Baxter Edwards1995-02-10
VIVALINK AED DEFIBRILLATOR (K940445)Survivalink Corp.1995-02-09
SCIMED TRANSENT EX STEERABLE GUIDE WIRE AND ACCESSORIES (K944677)Scimed Peripheral Interventions1995-02-08
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