Atlas FDA

Cardiovascular

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

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RecordFirmDate
RESUBMISSION OF MODEL 030-437 IMPLANT. ELECTRODE (K870610)Telectronics, Inc.1987-03-20
TARGET THERAPEUTICS TAPER GUIDE WIRE (K864316)Target Therapeutics1987-03-20
ADDITIONAL CARDIAC PACING LEADS #1020 THROUGH 1035 (K870824)Pacesetter Systems1987-03-20
PERCUTANEOUS INTRODUCER W/SIDE PORT 3 WAY STOPCOCK (K870374)Daig Corp.1987-03-18
BODY WATCH BODY COMPOSITION ANALYZER MODEL 2010 (K863833)Body Watch, Inc.1987-03-17
ARIES TAPERED SHEATH (K870189)Aries Medical, Inc.1987-03-16
HORIZON 1100 CARDIAC MONITOR (K864843)Mennen Medical, Inc.1987-03-16
RMI VENOUS DRAINAGE CANNULA (K870109)Research Medical, Inc.1987-03-16
GRUNWALD BI-CAVAL & JONES BI-CAVAL CANNULA (K870507)Research Medical, Inc.1987-03-16
S&W ELECTRODE TYPES 888, 844, 988 AND 944 (K864586)S & W Medico Teknik1987-03-13
PREGELLED DISPOSABLE ELECTRODE, SILVER-SILVER (K865011)Labeltape Meditect, Inc.1987-03-13
NIBP NON-INVAS. BLOOD PRESS. CART. MODEL 88 35 340 (K864737)Siemens Medical Solutions USA, Inc.1987-03-12
MODEL 78534C MONITOR/TERMINAL W/OPTIONS A03 (K870380)Hewlett-Packard Co.1987-03-11
TRACETS 2000/ELECTRODES (K863674)Lectec Corp.1987-03-11
SPACELABS MODEL 90419 PULSE OXIMETER MODULE (K864279)Spacelabs, Inc.1987-03-11
ERA-20 (K853194)Biotronik Sales, Inc.1987-03-11
DISPOS GEL EXTERNAL PACING ELECTRODE/LOW IMPEDANCE (K864985)Medac, Inc.1987-03-10
CARDIOFAX-V ECG-834OA (K865032)Nihon Kohden America, Inc.1987-03-10
CARDIOFAX-V ECG-8240A (K865030)Nihon Kohden America, Inc.1987-03-10
CARDIOMAX-II (K861543)Columbus Instruments Intl. Corp.1987-03-10
V-PACE(TM) TRANSLUMINAL VENTRICULAR/ MODEL SP5540 (K864507)Spectramed, Inc.1987-03-06
OMNI-TRAK (K864889)Invivo Research Labs, Inc.1987-03-06
502 OXYGEN SATURATION MONITOR (K864613)Criticare Systems, Inc.1987-03-04
MODEL PY...U UNIPOLAR & BIPOLAR PACING LEAD (K870034)Oscor Medical Corp.1987-03-03
ETP 180A NON-INVASIVE EXTERNAL PACEMAKER (K864989)Medac, Inc.1987-03-03
ETP 300 NON-INVASIVE EXTERNAL PACEMAKER (K864986)Medac, Inc.1987-03-03
BIOCHEM MICROSPAN 1040 OXIMETER (K870163)Biochem International, Inc.1987-03-03
ASPIRATING NEEDLE, CATALOG CODE #12006 (K865079)Dlp, Inc.1987-03-03
DAIG PACEMAKER LEAD ADAPTOR (K870562)Daig Corp.1987-03-03
MODEL EV4543 MINIATURE TEMPORARY CARDIAC PACEMAKER (K870323)Pace Medical1987-03-03
DISPOS GEL EXTERNAL PACING ELECTRODE/HI IMPEDANCE (K864987)Medac, Inc.1987-03-03
ETP 180E NON-INVASIVE EXTERNAL PACEMAKER (K864988)Medac, Inc.1987-03-03
SOFTIP CORONARY SINUS CARDIOPLEGIA CATHETER (K863342)Angiomedics, Inc.1987-03-03
PLURIMUS CARDIAC EVALUATION SYSTEM (K864401)Vivix Corp.1987-03-03
MODEL EL-1 W/ST MONITOR OPTION (ACRONYM = ELI/STM) (K864580)Mortara Instrument, Inc.1987-02-20
NUMED BALLOON WEDGE PRESSURE CATHETER (K864943)NuMED, Inc.1987-02-20
SENTRON PRESSURE MEASURING CATH/PRESSURE INTERFACE (K864320)Cordis Corp.1987-02-20
MANIFOLD SWIVEL ROTATOR MODELS 014320 & 014321-TAB (K870073)Clinical Connections, Inc.1987-02-20
ENDOMYOCARDIAL BIOPSY DEVICE (K870186)Mansfield Scientific, Inc.1987-02-20
MODIFIED LASERFLO BLOOD PERFUSION MONITOR (K864259)Tsi, Inc.1987-02-20
Q700 ELECTROCARDIOGRAPH (K864700)Quinton, Inc.1987-02-19
BIOMA 2000 (K862808)E.B.S., Inc.1987-02-19
APPLISCOPE (K864978)Grandcor Medical Systems1987-02-19
KONTRON SUPERMON CARDIAC OUTPUT MODULE 7263 (K862261)Kontron Instruments, Inc.1987-02-19
NUMED BALLOON ANGIOGRAPHIC CATHETERS (K864940)NuMED, Inc.1987-02-19
RMI FEMORAL VENOUS DRAINAGE CANNULA (K863740)Research Medical, Inc.1987-02-19
ASTRA T2, T4 AND T6 (K865013)Cardiac Pacemakers, Inc.1987-02-19
ELECTROCARDIOGRAPH (K865031)Nihon Kohden America, Inc.1987-02-19
MODIFIED GAS-STAT(TM) MONITORING SYSTEM (K864703)Cardiovascular Devices, Inc.1987-02-19
MTC 6210A CARDIAC OUTPUT COMPUTER (K854371)Nihon Kohden America, Inc.1987-02-19
STOCKERT-SHILEY CAPS VENOUS OCCLUSION CLAMP (K864890)Shiley, Inc.1987-02-19
MODIFIED STBP-680 (K863891)Quinton, Inc.1987-02-19
INTERSEPT* CARDIOTOMY RESERVOIR WITH FILTER (K864895)Johnson & Johnson Professionals, Inc.1987-02-19
AMPLATZ MOVEABLE CORE GUIDEWIRE (K864058)Lake Region Mfg., Inc.1987-02-19
SCHNEIDER-SHILEY GUIDE WIRE (K864787)Shiley, Inc.1987-02-19
MODIFICATION (MATERIAL CHANGE) OF PEEL-AWAY SHEATH (K864705)Quinton, Inc.1987-02-13
IMAGENET DIGITAL OPHTHALMIC IMAGING SYSTEM (K870039)Par Microsystems Corp.1987-02-12
MULTILITH 3 MODELS 1350, 3350, 1370, 3370 (K863898)Ela Medical, Inc.1987-02-10
COLIN STBP-780 STRESS TEST BLOOD PRESSURE MONITOR (K864654)Colin Medical Instruments Corp.1987-02-10
MEDI-TRACE INFANT ELECTRODE (K864722)Graphic Controls Corp.1987-02-10
FRANTZ MEDICAL ELECTRODE (K863508)Frantz Medical Development, Ltd.1987-02-06
MODIFIED MODEL BIA-103 BODY COMPOSITION ANALYZER (K862383)Rjl Systems, Inc.1987-02-03
CAPS LOW LEVEL DETECTOR & DETECTOR/BUBBLE MONITOR (K864619)Shiley, Inc.1987-02-03
2120 NON-INVASIVE BLOOD PRESSURE MONITOR W/CUFF (K861987)Ohmeda Medical1987-02-03
DIALOG MODELS 748, 748K AND 748T PULSE GENERATORS (K862226)Pacesetter Systems1987-02-03
CEN STA MON AC/DC ALARM CENTRAL ACCES ALARM RECOR (K863100)Honeywell, Inc.1987-02-03
EUB 151 ULTRASOUND SYSTEM/EUB 150 ULTRASOUND (K862859)Biosound, Inc.1987-02-02
ATL'S ULTRAMARK 6 ULTRASOUND SYSTEM (K864657)Advanced Technology Laboratories, Inc.1987-02-02
FST DISPOSABLE FIBER OPTIC TRANSDUCER #0100-00 (K864000)Fiberoptic Sensor Technlogies, Inc.1987-01-16
40CC PERCUTANEOUS FURL SINGLE INTRA-AORTIC BALLOON (K863185)Aries Medical, Inc.1987-01-16
MODEL 366-13 ADAPTAID STEP DOWN ADAPTER (K864326)Intermedics, Inc.1987-01-16
SYSTEM 90 TRANSPORT (K863219)Datascope Corp.1987-01-14
MICROPOROUS MONITORING ELECTRODES & ADAPTER BLOCK (K864868)Hewlett-Packard Co.1987-01-14
SIRECUST 888/888R NON-INVASIVE BLOOD PRESS MONITOR (K863042)Siemens Medical Solutions USA, Inc.1987-01-14
EDP-20 PACEMAKER (K860036)Biotronik Sales, Inc.1987-01-12
MINGOGRAF 410 (K864009)Siemens Medical Solutions USA, Inc.1987-01-12
MINOLTA/MARQUEST PULSOX-7 OXYGEN SATURATION MONIT. (K863918)Marquest Medical Products, Inc.1987-01-07
ACCUSAT (K863855)Datascope Corp.1987-01-06
MODEL 436-01 BIOPORE IMPLANTABLE PACING LEAD (K862051)Intermedics, Inc.1987-01-06
MEL-16-1, MEL-16-3 & MEL-16-5 TDK ECG ELECTRODES (K863369)Tdk Corp.1987-01-06
MODEL 5866-24 PACEMAKER LEAD ADAPTOR (K864856)Medtronic Vascular1987-01-06
SHEAR FORCE GAUGE (K864330)American Edwards Laboratories1987-01-06
MODIFICATION OF CARDIOINTEGRAM/CARDIOINTEGRAPH (K863153)Ocg Technology, Inc.1987-01-06
URESIL SUBCLAVIAN CATHETER (K863684)Uresil Corp.1987-01-06
CVI 8.5 FRENCH PERCUTANEOUS SHEATH INTRODUCER SYS. (K863917)Cardio-Vascular Innovations, Inc.1987-01-06
MODEL 366-14 INTERMEDICS LEAD CONNECTOR CAP (K864738)Intermedics, Inc.1987-01-06
ANGIOTOPO CATHETER (K861241)Houston Biomedical, Inc.1987-01-06
DISPOSABLE ECG MONITORING ELECTRODE (K863904)Clinical Data, Inc.1987-01-06
PACE IMPLANT. LEAD/TINED/ATRIAL/J/MODEL 3290 (K864153)Pace Medical1987-01-06
CVI 16 GAUGE CENTRAL VEIN CATHERIZATION SYSTEM (K863916)Cardio-Vascular Innovations, Inc.1987-01-06
MODIFICATION TO DYNASCOPE SERIES MONITORS (K863914)Fukuda Denshi USA, Inc.1987-01-06
MODIFIED PEEL-AWAY INTRODUCER SET LINE (K864352)Quinton, Inc.1987-01-06
ANCOR PERVENOUS ACTIVE FIXATION UNIPOLAR LEAD (K864640)Cordis Corp.1987-01-06
MEDTRONIC MODEL 5013 (K863536)Medtronic Vascular1987-01-06
MODIFIED RLV-2100 B (K864503)American Omni Medical, Inc.1987-01-06
CCS POLYSAFE(TM) ENDOCARDIAL PACING LEAD (K864601)Cardiac Control Systems, Inc.1987-01-06
LIFE-TRACE 18 SINGLE-TRACE CARDIAC MONITOR/RECORD. (K863535)Computerized Medical Systems, Inc.1987-01-06
PRUITT EMBOLECTOMY/IRRIGATION CATHETER (MODIFIED) (K864062)Ideas For Medicine, Inc.1987-01-06
METRIFLOW AFM-100 PERIPHERAL VASCULAR BLOOD FLOWME (K853952)Metriflow, Inc.1987-01-05
1990A BIO-RESISTANCE BODY COMPOSITION ANALYZER (K861205)Valhalla Scientific1987-01-05
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