Atlas FDA

Cardiovascular

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

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RecordFirmDate
MINATURE PRESSURE TRANSDUCER (K834040)Carbomedics, Inc.1984-02-10
TDK ECG ELECTRODE MEL-08 (K833899)Tdk Corp.1984-02-10
IMPLANTABLE BIPOLAR CARDIAC PULSE GEN (K833427)Telectronics, Inc.1984-02-10
GRADUATED GUIDE WIRE BOWL 8 (K834237)Sterile Design, Inc.1984-02-04
PORTABLE DEFIBRILLATOR (K840167)Honeywell, Inc.1984-02-04
CCS MODEL AV-102 IMPLANTABLE A-V DATA (K834342)Cardiac Control Systems, Inc.1984-02-04
LIFEPAK 7D (K840047)Physio-Control Corp.1984-02-04
LAL TEST RELEASE & BONCHEK CAR/JACKET (K833555)Shiley, Inc.1984-02-04
MAHURKAR DUAL LIMEN FEMORAL CATHETER (K834109)Quinton, Inc.1984-02-04
TRANS-PACE (K834262)Micromedical Devices, Inc.1984-02-04
SOFTIP CATHETER (K834275)Angiomedics, Inc.1984-02-04
DIAGNOSTIC RADIOLOGY CATHETERS (K834459)American Edwards Laboratories1984-02-04
IL HEPARINIZED FLOW DIRECTED THERMAL (K833836)Instrumentation Laboratory CO1984-02-04
HEART CATHETERIZATION TRAY SET (K840022)Medi-Plast Intl., Inc.1984-02-04
VERTEX PERCUTANEOUS CATHETER INTRODUC (K840017)Professional Medical Services1984-02-04
ELECATH HEPARIN COATED TEMP. PACING (K840109)Electro-Catheter Corp.1984-02-04
CARDIOTOMY RESERVORS BCR-3000/3500-Q-120 (K834373)American Bentley1984-02-04
PULSE GENERATOR MODEL 688 (K833519)Burditt & Calkins-Siemens-Elema1984-01-30
PROGRAMMABLE STIMULATOR 2352 (K833421)Medtronic Vascular1984-01-30
CARDIODATA PACE RECORDER (K834257)Cardio Data1984-01-30
HEPARIN-COATED BALLOON THERMODILUT (K833572)Critikon Company, LLC1984-01-30
LIFEPAK 7P (K832876)Physio-Control Corp.1984-01-30
CARDIOTOMY RESERVOIR SC3500F (K834041)Scimed Life Systems, Inc.1984-01-30
INFUSION PORT BALLOON THERMODILUTION (K833918)Critikon Company, LLC1984-01-30
ELECTRODE LEAD CONSTRUCTION (K834533)Telectronics, Inc.1984-01-30
VITAL SIGNS MONITOR 3 (K833584)Physio-Control Corp.1984-01-30
VERIFORM II (K833583)American Medical Systems, Inc.1984-01-30
AC ADAPTERS FOR BLOOD PRESSURE METERS (K833753)Philips Park1984-01-30
CONDUCTANCE METER (K833619)Circadian, Inc.1984-01-27
MAX I (K831763)Trade Max, Inc.1984-01-27
ALPHA CARDIAC OUTPUT CARDULE #1899 (K832644)Spacelabs, Inc.1984-01-27
ADULT MONITORING ELECTOR@@RODE 9431-300 (K833695)Marquette Electronics, Inc.1984-01-27
TREND PROCESSOR OPTION FOR #515 NEONAT (K833552)Ge Medical Systems Information Technologies1984-01-27
ADULT VENT CATHETER (K834352)Dlp, Inc.1984-01-27
HOLLOW FIBER MEMBRANE OXYGENATOR-HF4000 (K833078)Cordis Corp.1984-01-27
ALPHA NON-INVASIVE BP CARDULE (K832764)Spacelabs, Inc.1984-01-27
HOLTA-MED INFORMER PLAYBACK (K832354)Holta-Med1984-01-27
VASOSCAN (K833902)Sonicaid, Inc.1984-01-27
HYBRID PERIPHERAL DILATION CATHETER (K834220)American Edwards Laboratories1984-01-27
RAYDEN MEDICAL MINI PULSE VOLUME RECORD (K833155)Burditt & Calkins-Siemens-Elema1984-01-26
ROTARY VASCULAR KNIFE (K833547)Formedco, Inc.1984-01-26
ECG INTERFERENCE FILTER TF-03 (K832888)La Jolla Technology, Inc.1984-01-18
ANGIOPLASTY INFLATION DEVICE & CARTR (K834107)Cordis Corp.1984-01-13
CENTRAL VEIN CATH. TRAY CC-20-1420 (K833573)Intermed, Inc.1984-01-11
PORTA PULSE III #D320 (K833751)Medical Research Laboratories, Inc.1984-01-11
PERCUTANEOUS SHEATH INTRODUCER TRAYS (K833574)Intermed, Inc.1984-01-11
HEPARIN COATED BALLOON THERMODILU (K834037)Nova Medical Specialties1984-01-10
TELEMETRY SYS SERIES 7700 ECG (K832817)Marquette Electronics, Inc.1984-01-10
AMBULATORY MONITORING DEVICE (K833162)Oxford Medilog, Inc.1984-01-10
HEPARIN COATED BALLOON THERMODILU (K834036)Nova Medical Specialties1984-01-10
MULTI-LUMEN INTRAVENOUS INFUSION CATH (K833825)Medical Parameters, Inc.1984-01-10
INVASIVE MONITORING KITS (K832907)American Pharmaseal Div. Ahsc1984-01-10
SENTINEL SYSTEMS (K833395)Quantitative Medicine, Inc.1984-01-10
LP200 & HP800 SERIES VASCULAR PROSTH (K833716)Intervascular, Inc.1984-01-10
GORE-TEX SURGICAL MEMBRANE (K831516)W. L. Gore & Associates, Inc.1984-01-06
INFANT VENT CATHETER 12001 W/SIDE VENT (K834039)Dlp, Inc.1984-01-03
NON-INVASIVE CLINICAL VASCULAR LAB (K832679)Life Sciences Manufacturing, Inc.1984-01-03
SARNS CARDIOPLEGIA CANNULA Y (K834025)3M Health Care, Sarns1984-01-03
BOS-CM40,50 HOLDER & RESERVOIR BAG (K833670)American Bentley1984-01-03
BTI BIOX III OXIMETER CRITICAL CAREUNI (K833826)Biox Technology, Inc.1983-12-30
LOW TRAUMA ARTERIAL FILTER H-640 (K831507)C.R. Bard, Inc.1983-12-29
USE OF TWEEN 80 AS A WETTING AGENT ON (K832802)American Bentley1983-12-29
PHYSIO-PROBE-HIGH PERMEABILITY CATH. (K833433)Research Industries Corp.1983-12-29
BLOOD OXYGENATOR HEAT EXHANGER COATING (K833518)American Bentley1983-12-29
CARDIOPLEGIA SYSTEM CCS-XXX SERIES (K833662)Gish Biomedical, Inc.1983-12-29
INTERSEPT 40 MICRON FILTER W/TUBING (K833476)Extracorporeal Medical Specialities, Inc.1983-12-27
CARDIOPULMONARY RESUSCITATOR (K833879)Michigan Instruments, Inc.1983-12-27
CARDIOTOMY RESERVOIR-FILTER 050-108-050 (K832671)Cobe Laboratories, Inc.1983-12-27
DUOFLO 6F (K833303)Argon Medical Corp.1983-12-27
INTERSEPT 40 MICRON FILTER (K833477)Extracorporeal Medical Specialities, Inc.1983-12-27
OPEN END SPRING GUIDE (K832607)C.R. Bard, Inc.1983-12-27
PERI-GUARD PERICARDIAL PATCH-HERNIA (K833021)Genetic1983-12-26
OLBERT CATHETER SYSTEM (K833616)Meadox Medicals, Div. Boston Scientific Corp.1983-12-26
LOW PROFILE STEERABLE-INTRAOPERATIVE (K833248)Advanced Cardiovascular Systems, Inc.1983-12-22
ACTIMETER UB-103 (K832724)Copal, Inc.1983-12-22
NARCOTRACE 80 (K830338)Narco Scientific1983-12-22
PRE-GELLED DISPOS ELECTRODE (K832877)Advance Tech Intl.1983-12-22
MONITORING SYSTEM AS100-AS115 RECORD (K832754)Air-Shields, Inc.1983-12-22
VASCUTEK VASCULAR PROTHESIS VP1200K/50K (K830016)Pacesetter Systems1983-12-21
TUBING CONNECTORS EC-2XXX SERIES (K833322)Gish Biomedical, Inc.1983-12-16
WILLIAM HARVEY H-71-5-F CARDIOTOMY (K833479)C.R. Bard, Inc.1983-12-16
CARIEL F12 (K823934)Odam1983-12-16
8 FRENCH DILATOR 15CM, W/LUER LOCK (K833965)Quinton, Inc.1983-12-16
BATTERY-OPERATED ELECTROCARDIOGRAPH (K832421)Somatronix Research Corp.1983-12-16
MAGNATRODE CARDIAC MONITORING ELECTRODE (K832516)R2 Corp.1983-12-16
EXTERNAL PULSE GENERATOR FOR TEMP. STIM (K831768)Oscor, Inc.1983-12-16
PACEMAKER SYS ANALYZER #384 (K833647)Pacesetter Systems1983-12-16
IMPLANTABLE PULSE GENERATOR (K834096)Intermedics, Inc.1983-12-16
MORTARA INSTRUMENT #101 (K832050)Mortara Instrument, Inc.1983-12-13
DIF-STET (K832882)Intersect Systems, Inc.1983-12-06
MINI-PECG (K832883)Intersect Systems, Inc.1983-12-06
ENDOCARDIAL SCREW-IN LEAD 859 & 861 (K833824)Pacesetter Systems1983-12-01
PHOTOFLO DUAL-MODE PHOTOPLETHYSMOGRAPH (K832374)Sonicaid, Inc.1983-12-01
NAMIC CONTINUOUS FLUSH DEVICE (K833271)North American Instrument Corp.1983-12-01
G-2000 (K832227)Eaton Medical Group1983-12-01
OPTIMA MDT PULSE GENERATOR W/TELEMETRY (K833798)Telectronics, Inc.1983-12-01
HOLTER PERFORMER FEATHER WEIGHT/CASS (K833823)Applied Cardiac Systems1983-12-01
SHILEY M2000 MEMBRANE OXYGENATOR (K833253)Shiley, Inc.1983-12-01
BIOSENSOR ASC SYSTEM (K831676)Biosensor Corp.1983-12-01
PATIENT MONITOR CM 135 (K831164)Honeywell, Inc.1983-12-01
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