Atlas FDA

Cardiovascular

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

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RecordFirmDate
CORDIS MULTICOR II MODEL 402D PACER (K863417)Cordis Corp.1986-10-08
MODEL 725TH HANDHELD TRANSCEIVER (PROGRAMMER) (K863582)Cook Pacemaker Corp.1986-10-08
MODIFICATION OF STERILITY CYCLE PARAMETERS (K863365)Coratomic, Inc.1986-10-08
Q4000 AND Q3040 ELECTROCARDIOGRAPH MONITOR (K863159)Quinton, Inc.1986-10-06
SIREDOC 60 AND SIREDOC 220 (K863331)Siemens Medical Solutions USA, Inc.1986-10-06
TRACKER INFUSION CATHETER (K862117)Target Therapeutics1986-10-01
STOCKERT-SHILEY CAPS TIMER MODULE (K862973)Shiley, Inc.1986-10-01
NOVEMPERC DOUBLE LUMEN INTRA-AORTIC BALLOON (K860638)Kontron Instruments, Inc.1986-10-01
MEDCOMP DISPOSABLE MANIFOLD SYSTEM (K863661)Medical Components, Inc.1986-09-29
BARD WILLIAM HARVEY CARDIOTOMY RESERVOIR (K862920)C.R. Bard, Inc.1986-09-29
CORDIPAK CARDIAC CATHETERIZATION PACK (K863337)Angi-Pak Corp.1986-09-29
PROGRAMMER MODEL 2035/ELECTROGRAM CABLE MODEL 6580 (K863045)Cardiac Pacemakers, Inc.1986-09-29
HEPARIN-COATED EXTRACORPOREAL CIRCUITS (K861641)American Bentley1986-09-29
SENSORMEDICS OXYSHUTTLE(TM) (K862617)Sensor Medics Corp.1986-09-26
DR-2C (MODIFICATION) (K862596)General Devices1986-09-26
MODEL 352-01 SILICONE RUBBER ISOLATION SLEEVE (K863418)Intermedics, Inc.1986-09-24
BUCHBINDER(TM) MULTIFLEX(TM) GUIDEWIRE (K862937)Versaflex Delivery Systems, Inc.1986-09-24
MODIFIED CARDIOCAP MONITOR (K862455)Datex Division Instrumentarium Corp.1986-09-24
MODIFIED PTCA GUIDING CATHETERS (K862975)Cordis Corp.1986-09-23
USCI (R) DISPOSABLE INFLATION DEVICE (K863037)C.R. Bard, Inc.1986-09-23
SCIMED II-SM25 MEMBRANE OXYGENATOR SYSTEM (K862918)Scimed Life Systems, Inc.1986-09-23
BIOTRONIK PERMANENT PACEMAKER ELECTRODE (K863480)Biotronik Sales, Inc.1986-09-23
SPACELABS SERIES 90700 PATIENT MONITORS (K862951)Spacelabs, Inc.1986-09-23
MODIFIED MAHURKAR SUBCLAVIAN & FEMORAL CATHETERS (K863322)Quinton, Inc.1986-09-19
ADDITIONAL TARGET THERAPEUTICS GUIDE WIRES (K862983)Target Therapeutics1986-09-19
MODEL 430-01 BIOPORE IMPLANTABLE PACING LEAD (K862054)Intermedics, Inc.1986-09-19
UMI STEERABLE TORQUE GUIDE WIRE (K863178)Universal Medical Instrument Corp.1986-09-19
MODEL 432-01 BIOPORE IMPLANTABLE PACING LEAD (K862053)Intermedics, Inc.1986-09-19
CARDIOFAX ECG-6551 (ELECTROCARDIOGRPH) (K863116)Nihon Kohden America, Inc.1986-09-17
SKINTACT AG ELECTRODES (K862618)Leon H. Lang Co.1986-09-15
VASCUTEK VASCULAR PROSTHESES, EXTRA SOFT/LOW WOVEN (K861808)Cobe Laboratories, Inc.1986-09-15
CARDIAN II CR45A (K861621)Cardiac Recorders, Ltd.1986-09-12
STOCKERT-SHILEY CAPS AND CAPS DUAL PRESSURE MODULE (K862836)Shiley, Inc.1986-09-12
MODEL 6615 FLOSCAN DOPPLER DIAGNOSTIC CATHETER (K862673)Medtronic Vascular1986-09-11
ACS HI-TORQUE FLEX-T GUIDE WIRE (K862360)Advanced Cardiovascular Systems, Inc.1986-09-11
PULSE OXIMETER (K862426)Draeger Medical, Inc.1986-09-11
MODEL 617D (K863303)Quinton, Inc.1986-09-05
INTERFACE ARTERIAL BLOOD FILTER, MODEL 44 (K862609)Medical, Inc.1986-09-04
ACS WIRE SHAPER (K862567)Advanced Cardiovascular Systems, Inc.1986-09-04
ALTERNATE PACKAGE CONFIG. FOR IMPLANT. PULSE GEN. (K862974)Medtronic Vascular1986-09-04
INTERFACE ARTERIAL BLOOD FILTER, MODEL 42 (K862591)Medical, Inc.1986-09-04
MECHANICAL INFLATION DEVICE (K862547)American Edwards Laboratories1986-09-03
OLBERT CATHETER SYSTEM WITH SIDEWINDER CURVE (K862550)Meadox Surgimed, Inc.1986-09-02
HA-2 HUMAN BODY COMPOSITION ANALYZER (K860749)Dj Medical Instrument Corp. C/O Keller & Heckman1986-09-02
DESERET FLO-THRU INJECTATE TEMPERATURE SENSOR (K862119)Parke-Davis Co.1986-08-29
LEFT VENTRICULAR VENT VALVE MODEL NO. GLV (K862540)Gish Biomedical, Inc.1986-08-29
SCHNEIDER-SHILEY FLUSHING CATHETER (K862466)Shiley, Inc.1986-08-29
OSCOR MEDICAL FIX SCREW PACING LEAD/PEELABLE CATH (K861493)Oscor Medical Corp.1986-08-28
BURDICK DIVISION (E-500) (K861850)Mortara Instrument, Inc.1986-08-28
CERYX PACEMAKER MODELS 114, 314 & 614 (K854790)Vitatron Medical BV1986-08-28
SIEMENS-ELEMA (SICARD-P) (K861851)Mortara Instrument, Inc.1986-08-28
SCHNEIDER-SHILEY Y-CONNECTOR WITH ROTATOR (K862464)Shiley, Inc.1986-08-28
MINIOX 100 PULSE OXIMETER (K862798)Catalyst Research Corp.1986-08-28
OSCILLOMATE BLOOD PRESSURE MONITOR-MODEL 915 (K860488)Cas Medical Systems, Inc.1986-08-25
[CENTRAL VENOUS][MULTI-LUMEN] CATHETER W/FLEX TIP (K862056)Arrow Intl., Inc.1986-08-25
CIRCADIAN STRESS TEST SYSTEM (K860973)Circadian, Inc.1986-08-25
MODEL SC-1000 ELECTROCARDIOGRAPH SPECIFICATION (K862748)Cambridge Medical Instruments, Inc.1986-08-25
MINI-HOLTER, MODEL 2000 (K862526)Holter Recorders1986-08-25
MODEL FB-20 NON-INVASIVE BLOOD PRESSURE MONITOR (K861504)Fukuda Denshi USA, Inc.1986-08-25
ELECTROCARDIOGRAPH LEAD SWITCHING ADAPTOR (K861981)Vital Signs, Inc.1986-08-25
CLASSIC RESTING SILVER-SILVERCHLORIDE ELECTRODE (K862953)Classic Medical Products, Inc.1986-08-25
MODIFICATIONS TO CORDIS' SUPER FLOW CATHETERS (K862244)Cordis Corp.1986-08-25
INTERVASCULAR OCHSNER MICRON VASCULAR PROSTHESES (K862739)Intervascular, Inc.1986-08-21
MODIFIED CARDIOTOMY RESERVOIR 5M1470 (K862357)3M Health Care, Sarns1986-08-19
SEAMED MODEL 3000 (K860462)Seamed Corp.1986-08-19
MODIFICATION OF TISSUE DILATOR (K862288)Quinton, Inc.1986-08-19
MODEL SP1465 CARDIAC OUTPUT COMPUTER (K861092)Gould, Inc.1986-08-18
SPECTRUM POLYCORD I RECORDER SYSTEM (K862776)Cardionics, Inc.1986-08-18
INTERVASCULAROCHSNER 50 AND OCHSNER 500 VASCULAR (K854845)Intervascular, Inc.1986-08-18
PHYSIOLOGICAL MONITOR, MODELS 401,402 & 403 (K862647)Ivy Biomedical Systems, Inc.1986-08-18
OSC-80 OXIMETER (K862161)Waters Instruments, Inc.1986-08-18
AMBULATORY BLOOD PRESSURE MONITOR SPACELABS #90202 (K855127)Spacelabs, Inc.1986-08-14
DIFFERENTIAL STETHOSCOPE W/DUAL HEADS; STEREOSCOPE (K860473)Schering Corp.1986-08-14
SCHNEIDER-SHILEY OCCLUDER/FLUSHING CATH. STOPCOCK (K862465)Shiley, Inc.1986-08-11
SCHNEIDER-SHILEY SELDINGER INITIAL PUNCTURE INSTR (K862467)Shiley, Inc.1986-08-11
NEOS VS-1, PULSE GENERATOR (K860921)Biotronik Sales, Inc.1986-08-08
MODIFIED OSCOR PY PACING LEADS (K862330)Oscor Medical Corp.1986-08-08
POLY-TECH ANGIOGRAPHY CATHETER (K862030)Poly-Tech Medical Device Research & Development1986-08-08
GELMAN ARTERIAL FILTER (43, 33 AND 21 MICRON) (K862068)Gelman Sciences, Inc.1986-08-08
NEOGUARD ECG ELECTRODES (K861364)Cas Medical Systems, Inc.1986-08-06
EUROMED S-601 (K862765)Lectec Corp.1986-08-06
KENZ-ECG-102 SINGLE CHANNEL ELECTROCARDIOGRAPH (K862544)Suzuken Co., Ltd.1986-08-06
EM DIAGNOSTIC ECG ELECTRODE (K862746)Electromed Intl., Ltd.1986-08-06
PREMIE DISC ECG ELECTRODE W/PREATTACHED LEAD (K861246)Conmedcorp1986-08-06
SIGNA II RESTING ECG ELECTRODE (K862655)Kone Instruments, Inc.1986-08-06
GOULD XCALIBER (K862344)Bio-Tek Instruments, Inc.1986-08-06
MODEL MB-500 & MB-600 BLOOD PRESSURE MONITORS (K861375)Sharp Electronics Corp.1986-08-06
GEREONICS BIOPOTENTIAL SKIN ELECTRODES (K861099)Gereonics, Inc.1986-08-06
PREGELLED INFANT DISPOSABLE ECG ELECTRODE (K862756)Labeltape Meditect, Inc.1986-08-06
UMI CATH-SEAL, 13+14F & TRANSSEPTAL CATHETER INTRO (K861984)Universal Medical Instrument Corp.1986-08-05
CORDIS ANCOR ACTIVE FIXATION LEAD (K832422)Cordis Corp.1986-08-05
CORDIS HI-FLEX PERVENOUS ACTIVE FIXATION UNIPOLAR (K851064)Cordis Corp.1986-08-05
MEDTRONIC MODEL 5328 PROGRAMMABLE STIMULATOR (K861368)Medtronic Vascular1986-08-04
MIKROS, MIKROS VS-1, PULSE GENERATOR (K860922)Biotronik Sales, Inc.1986-08-04
MICROCOR E.C.G. MONITOR WITH A.C. ADAPTER (K861281)Microcor, Inc.1986-08-01
ACUSON L558 TRANSDUCER (K861579)Acuson Computed Sonography1986-07-30
PACEMAKER LEAD ADAPTER (K862656)Cordis Corp.1986-07-30
ACUSON S519 TRANSDUCER (K861596)Acuson Computed Sonography1986-07-30
SPACELABS P.C. CARDIAC OUTPUT/PRESSURE MODULE (K860689)Spacelabs, Inc.1986-07-30
MILLAR PULSED DOPPLER VELOCIMETER (K860766)Millar Instruments, Inc.1986-07-29
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