Atlas FDA

Cardiovascular

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

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RecordFirmDate
DISPOSABLE ECG MONITORING ELECTRODE #4570 38X60MM (K950478)Nikomed U.S.A., Inc.1995-11-06
DISPOSABLE ECG MONITORING ELECTRODE #4533 32X45MM (K950474)Nikomed U.S.A., Inc.1995-11-06
DISPOSABLE ECG MONITORING ELECTRODE #4535 32X45MM (K950470)Nikomed U.S.A., Inc.1995-11-06
WITT BIOMEDICAL SERIES IV (K950436)Witt Biomedical Corporation1995-11-02
SPIRALGOLD & SPIRALOXY HOLLOW FIBER OXYGENATORS (K951247)Baxter Healthcare Corp1995-11-02
ANALYST, MODEL DSP 300 (K950760)Heart Sounds, Inc.1995-10-31
BLOOD PRESSURE CUFF 3 (K951041)Pedia Pals, Inc.1995-10-31
BLOOD PRESSURE CUFF 2 (K951040)Pedia Pals, Inc.1995-10-31
BLOOD PRESSURE CUFF 1 (K951039)Pedia Pals, Inc.1995-10-31
CARDIOMAGIC(R) SOFTWARE ENHANCEMENTS (K950003)Instromedix, Inc.1995-10-31
MINISCOPE MS-3 (K954066)Schiller America, Inc.1995-10-27
FEMOSTOP, FEMOSTOP PUMP (K954669)Radi Medical Systems AB1995-10-27
A-V IMPULSE SYSTEM MODEL 6060 (K951683)Novamedix , Ltd.1995-10-26
DIGITAL BLOOD PRESSURE METER - MODEL NO.: BPM883 (K951977)Integrated Display Technology, Ltd.1995-10-24
HEARTVIEW(TM) 12-LEAD ELECTROCARDIOGRAPH RECORDER/TRANSMITTER (K950004)Aerotel, Ltd.1995-10-24
5F ENVOY GUIDING CATHETER (MODIFICATION) (K954251)Cordis Neurovascular, Inc.1995-10-23
NELLCOR SYMPHONY N-3100 BLOOD PRESSURE MONITOR (K953472)Nellcor, Inc.1995-10-20
6200 VITAL SIGNS MONITOR (K953415)Bci Intl., Inc.1995-10-19
EAGLE 3000 PATIENT MONITOR (K952474)Marquette Electronics, Inc.1995-10-19
SYMMETRY SMALL VESSEL BALLOON DILATATION CATHETER (K953602)Boston Scientific Corp1995-10-18
RADIFOCUS GLIDEWIRE FOR CORONARY USE WITH PLATINUM (OR GOLD) COIL (K953533)Terumo Medical Corp.1995-10-18
ECOTABS (K950587)Msb , Ltd.1995-10-16
VITALOGRAPH 2110 SOFTWARE INTERFACE (K950854)Vitalograph , Ltd.1995-10-12
TRANSVENOUS, PERMANENT TINED TARGET TIP PACING LEADS (K951858)Medtronic Vascular1995-10-12
AIRPERFECT 1000 (SINGLE-USER SYSTEM), AIRPERFECT 2000 (MULTI-USER SYSTEM) (K951684)Digital Air Corp.1995-10-06
AFFINITY ARTERIAL BLOOD FILTER (K952532)Avecor Cardiovascular, Inc.1995-10-06
DIASTAT VASCULAR ACCESS GRAFT (K953287)W. L. Gore & Associates, Inc.1995-10-06
DIASTAT VASCULAR ACCESS GRAFT (K953288)W. L. Gore & Associates, Inc.1995-10-06
ZYMED TELEMETRY SYSTEM; MODEL T8010 (K951370)Zymed Medical Instrumentation1995-10-06
CARDIMA, INC. FORERUNNER (K951603)Cardima, Inc.1995-10-05
CATHETER, BALLOON TYPE (K950398)Interventional Therapeutics Corp.1995-10-05
1481 T DIGITAL TELEMETRY SYSTEM WITH S-T SEGMENT ANALYSIS OPTION (K951371)Siemens Medical Solutions USA, Inc.1995-10-04
HP M1205A OMNICARE COMPONENT TRANSPORT MONITORING SYSTEM MODEL 24 (K950821)Hewlett-Packard Co.1995-10-03
MINIFLEX MODEL 340, 341, AND 342 PULSE GENERATORS (K953417)Cook Pacemaker Corp.1995-09-29
NANOS, PIKOS 01/E01, 01-A, E01-B, LP 01/LP E01 (K952328)Biotronik, Inc.1995-09-29
DEROYAL INDUSTRIS, INC. BLOOD PRESSURE CUFF (K953952)Deroyal Industries, Inc.1995-09-28
LIFEPAK 10 DEFIBRILLATOR/MONITOR/PACEMAKER, AND LIFEPAK 11 CARDIAC MONITOR (K945511)Physio-Control Corp.1995-09-26
SINGLE LEAD DIGITAL TELEMETRY TRANSMITTER (K952885)Spacelabs Medical, Inc.1995-09-26
MEDRAD SPECTRIS MR INJECTOR (K935668)Medrad, Inc.1995-09-25
FASGUIDE (K951159)Target Therapeutics1995-09-25
PRECEDER GUIDEWIRE (K953023)Boston Scientific Corp1995-09-21
OXILINK (SMALL, MEDIUM, LARGE) (K953126)Bci Intl., Inc.1995-09-21
RESPIRATORY AND CARDIAC SPECTRAL FREQUENCY SIGNAL PROCESSOR (K941252)Ansar1995-09-20
SCIMED TRIGUIDE GUIDE CATHETERS (K953515)Scimed Life Systems, Inc.1995-09-19
LIFE SOUND SENSOR (K952651)Flowscan, Inc.1995-09-19
EPICARDIA (K952846)Medicomp, Inc.1995-09-18
AUSCULATOR GPS (K953218)Lyte Industries, Inc.1995-09-18
CARDIO SERV (K951110)Hellige GmbH1995-09-15
GENERICUFF (K953466)Generic Medical, Inc.1995-09-15
DUAL FUNCTION PACING WEDGE PRESSURE BALLOON CATHETER BY J-LLOYD (K950440)J-Lloyd Medical, Inc.1995-09-15
UST-5268P-5 TRANSDUCER (K950607)Aloka Co., Ltd.1995-09-15
CUFF GUARD (K952825)Bowen Medical Services, Inc.1995-09-15
DISPOSABLE ECG MONITORING ELECTRODE #4600 60MM, #4610 45MM (K950479)Nikomed U.S.A., Inc.1995-09-13
BAIR HUGGER MODEL 655 BLANKET (K952864)Augustine Medical, Inc.1995-09-12
EVOLUTION MICROCATHETER (K953114)Boston Scientific Corp1995-09-12
HEARTCARD CARDIAC EVENT MONITOR (K944362)Instromedix, Inc.1995-09-07
MARQUETTE DEFIB ELECTRODES (K952101)Marquette Electronics, Inc.1995-09-07
TROPICAIR CONVECTIVE WARING SYSTEM (K946196)Seabrook Medical Systems, Inc.1995-09-06
DISPOSABLE ECG MONITORING ELECTRODE #4440 60MM, #4420 40MM (K950476)Nikomed U.S.A., Inc.1995-09-06
TROPICAIR CONVECTIVE WARMING BLANKETS (K952086)Seabrook Medical Systems, Inc.1995-09-06
OPUS PACEMAKERS (MODELS 4001, 4003, 4004, 4023, 4024) (K952364)Ela Medical, Inc.1995-09-01
OSCILFLATOR (K952566)Surgical Technologies, Inc.1995-08-31
PASSIVE PLUS PACING LEADS WITH TITANIUM NITRIDE COATING (K951950)Pacesetter, Inc.1995-08-31
PASSIVE PLUS PACING LEADS WITH TITANIUM NITRIDE COATING (K952206)Pacesetter, Inc.1995-08-31
CARDIOMETRICS ACCUTRAC INTRAVASCULAR GUIDE WIRE (K952562)Cardio Metrics, Inc.1995-08-29
BAIR HUGGER MODEL 600 UNIT, BLANKETS (K950416)Augustine Medical, Inc.1995-08-29
SMARTSAT PULSE OXIMETRY ANALYZER (K952327)Clinical Dynamics Corp.1995-08-25
QUEST VEIN GRAFT PERFUSION SET (K952531)Quest Medical, Inc.1995-08-24
TETRAFLUOROETHYLENE (TFE) POLYMER PLEDGET (K953289)Davis & Geck, Inc.1995-08-21
DIDECO ADULT ARTERIAL FILTERS D732 MICRO 20 W/20, D734 MICRO 40 W/40 MICRON SCREEN (K952270)Sorin Biomedical, Inc.1995-08-21
POLYETHYLENE TEREPHTHALATE (PET) PLEDGET (K953425)Davis & Geck, Inc.1995-08-21
TRANSIT INFUSION CATHETER (K952874)Cordis Neurovascular, Inc.1995-08-21
FINESSE GUIDEWIRE CORONARY (K952430)Flexmedics1995-08-18
FOGARTY-HYDRAGRIP SURGICAL CLAMPS (K951413)Baxter Healthcare Corp1995-08-18
MEDI-TECH PERCUTANEOUS INTRODUCER SYSTEM (K952828)Boston Scientific Corp1995-08-18
CVD PERIFLOW(TM) (SMALL VESSEL) BALLOON DILATATION CATHETER (K945693)Cardiovascular Dynamics, Inc.1995-08-17
BRAUN SELECTIVE ANGIOGRAPHIC CATHETER (K950882)B.Braun Medical, Inc.1995-08-17
HOLTER PACERCORDER(R) (K950020)Del Mar Avionics1995-08-17
NELLCOR SYMPHONY N-3000 PULSE OXIMETER (K952316)Nellcor, Inc.1995-08-17
MEDI-TECH PLATFORM GUIDE CATHETER (K952345)Medi-Tech, Inc.1995-08-17
CAPIOX SP PUMP HEAD (K943861)Terumo Corp.1995-08-15
NELLCOR N-20PA PORTABLE PULSE OXIMETER (K952222)Nellcor, Inc.1995-08-15
SPACELABS MEDICAL EXPANSION MODULE (MODEL 90352) (K945429)Spacelabs Medical, Inc.1995-08-15
SORBA MODEL CIC-1000 NON-INVASIVE HEMODYNAMIC MONITOR (K950389)Sorba Medical Systems, Inc.1995-08-15
BSC/CA 30 & 40 SENSATION, MODELS 930 & 940 (K952221)Boston Scientific Corp1995-08-11
HEWLETT-PACKARD MODEL M1264B CATHSTATION (K952173)Hewlett-Packard Co.1995-08-11
USCI INPUT INTRODUCER SET (K940092)Usci, Div. C.R. Bard, Inc.1995-08-10
ARROW MULTIPOLAR INTRACARDIAC ELECTRODE CATHETERS (K945229)Arrow Intl., Inc.1995-08-08
TRANSIT-2 INFUSION CATHETER (K950910)Cordis Neurovascular, Inc.1995-08-08
ACS POWERBASE GUILDING CATHETER (K952205)Advanced Cardiovascular Systems, Inc.1995-08-04
RAPID-TRAK(TM) INTRODUCER SHEATH (K950155)Cardio Vascular Concepts, Inc.1995-08-02
CORDIS BRITE TIP, ENVOY GUIDING CATHETER (K952185)Cordis Corp.1995-08-02
DYNABITE CARDIOVASCULAR BIOPSY FORCEPS (K951447)Portlyn Corp.1995-07-27
MULTIPACE (K934785)Electro-Catheter Corp.1995-07-27
SSCIMED CORONARY GUIDE WIRE/INFUSION CATHETER (K952872)Scimed Life Systems, Inc.1995-07-27
MOLLRING CUTTER (K950813)Cardio Vascular Concepts, Inc.1995-07-25
MEDTRONIC(R) GC III CORONARY GUIDING CATHETER (K950179)Medtronics Interventional Vascular1995-07-25
CAPIOX ARTERIAL FILTER (K943917)Terumo Medical Corp.1995-07-25
SCIMED ENCORE ADVANTAGE KIT AND THE ESSENTIALS KIT (K951802)Scimed Life Systems, Inc.1995-07-21
FEMOSTOP II (K944259)Radi Medical Systems AB1995-07-20
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