Atlas FDA

Cardiovascular

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

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RecordFirmDate
ACUSON S319 TRANSDUCER (K862159)Acuson Computed Sonography1986-07-24
MERIDIAN IMAGING SYSTEM (K861737)Johnson & Johnson Professionals, Inc.1986-07-24
RMI BALLOON-OCCLUSIVE CAROTID BY-PASS SHUNT (K861790)Research Medical, Inc.1986-07-21
THE NAVIGATOR STEERABLE GUIDE WIRE (K860430)Meadox Surgimed, Inc.1986-07-18
IMPLANTABLE ELECTRODE LEAD, MODEL 030-436 (K861767)Telectronics, Inc.1986-07-18
CARDIOMET 4000 GAS MONITORING SYSTEMS (K862069)Biomedical Sensors, Inc.1986-07-18
MICRON, MICROVASCULAR DOPPLER (K860651)Diagnostic Electronics Corp.1986-07-18
COBE ACCESSORY INTERFACE MODULE (AIM) (K861860)Cobe Laboratories, Inc.1986-07-18
ACUSON L382 AND L312 TRANSDUCERS (K861866)Acuson Computed Sonography1986-07-18
FUTUREMED ECG SYSTEM 500 (K862381)Futuremed Div. of Future Impex Corp.1986-07-17
DISPOSABLE STOPCOCK (K861783)Utah Medical Products, Inc.1986-07-17
STOCKERT-SHILEY CAPS 4 CHANNEL TEMP. MONITOR 1 (K862510)Shiley, Inc.1986-07-17
ANGIOFLOW (K854910)Angiomed U.S., Inc.1986-07-17
STOCKERT-SHILEY MULTIFLOW ROLLER PUMP MODULE (K861714)Shiley, Inc.1986-07-16
ANGIOMEDICS CATH SHEATH INTRODUC W/HEMOSTASIS VALV (K861238)Angiomedics, Inc.1986-07-16
ASTRA T2, T3, T4 & T6 MULTIPROGRAM PULSE GENERATOR (K860585)Cardiac Pacemakers, Inc.1986-07-16
STOCKERT-SHILEY DOUBLE HEAD PUMP MODULE (K862116)Shiley, Inc.1986-07-16
ARTERIAL BLOOD FILTER HOLDER MODEL NO. AF-HE (K862549)American Bentley1986-07-15
PINNACLE MULTI-PROGRAMMABLE PACING SYS (K853771)Cardio-Pace Medical, Inc.1986-07-15
SIEMENS SIRECUST MODELS 403P,403-2P & 403N (K855096)Analogic Corp.1986-07-15
SNAP-ON TORQUER (K862409)Advanced Cardiovascular Systems, Inc.1986-07-11
ALTERNATE SIZE E-Z-PACE ELECTRODE (K862298)Medtronic Vascular1986-07-11
TORAY SUPERSELECTIVE GUIDEWIRE,SUPERSELEC Y-K TYPE (K861115)Toray Industries (America), Inc.1986-07-11
CURITY CENTRAL VENOUS CATHETERIZATION TRAY (K861827)The Kendal Co.1986-07-11
MODEL 431-02 BIOPORE IMPLANTABLE PACING LEAD (K862257)Intermedics, Inc.1986-07-10
MEDTRONIC TEMPORARY AND IMPLANTABLE PACING LEADS (K862443)Medtronic Vascular1986-07-10
MODEL 437-01 BIOPORE IMPLANTABLE PACING LEAD (K862258)Intermedics, Inc.1986-07-10
ACS CORONARY GUIDING CATHETER (K861236)Advanced Cardiovascular Systems, Inc.1986-07-10
MODEL 433-01 BIOPORE IMPLANTABLE PACING LEAD (K862259)Intermedics, Inc.1986-07-10
CURITY CENTRAL VENOUS CATHETER (K861829)The Kendal Co.1986-07-10
CURITY VENOUS CATHETERIZATION KIT (K861828)The Kendal Co.1986-07-10
MODEL UST-SSD 880L1-5 TRANESOPHAGEAL PHASED ARRAY (K861710)Johnson & Johnson Professionals, Inc.1986-07-09
ULTRAMED TF 122 ULTRASON VASCU IMAG & DOPPLER SYST (K861378)Ultramed, Inc.1986-07-07
MODEL 438-01 CARDIFIX IMPLANTABLE PACING LEAD (K862052)Intermedics, Inc.1986-07-03
MODEL 435-02 CARDIFIX IMPLANTABLE PACING LEAD (K862276)Intermedics, Inc.1986-07-02
DIGITAL SUBTRACTION ANGIOGRAPHY CATHETERS AND SETS (K860867)Medical Components, Inc.1986-07-02
PANASONIC BLOOD PRESSURE METER, ZH-852AP, ZH-858PP (K860634)Panasonic Co. Div. Matsu Elec. Corp. America1986-07-01
S&W TYPE 888 ELECTRODE (K861158)National Medical Technology1986-07-01
MODIFIED MODELS 8320/8322/8329/8316/8317/8318 (K861719)Medtronic Vascular1986-07-01
CARDIO PORT 500 24-H ECG AMBULATORY MONITOR SYSTEM (K862375)Grandcor Medical Systems1986-07-01
CARDIOSCAN DOPPLER OPTION (K860579)Interspec, Inc.1986-06-30
TB SERIES BIPOLAR PACING LEADS (K861403)Oscor Medical Corp.1986-06-27
STAND & HIGH FLOW FEMORAL-VENTRICULAR PIGTAIL CATH (K862006)Cordis Corp.1986-06-27
SUCTION CONTROL VALVE (NONADJUSTABLE) CAT.RLV-2100 (K861428)American Omni Medical, Inc.1986-06-26
CORDIS HI-FLEX PERVENOUS BIPOLAR LEAD (K860846)Cordis Corp.1986-06-26
PACESETTER/SIEMENS PULSE GENERA W/VS-1 HEAD CAVITY (K861422)Pacesetter Systems1986-06-26
OXYGENATOR MODEL NOS. BENTLEY-10A & BENTLEY-10B (K860673)American Bentley1986-06-26
ORG-7201 MULTIPARAMETER TELEMETRY MONITOR (K860239)Nihon Kohden America, Inc.1986-06-26
BARD-PARKER CAROTID SHUNT (K860136)Bd Becton Dickinson Vacutainer Systems Preanalytic1986-06-25
S80 IMPLANTABLE CARDIAC PACING LEAD (K854963)Sorin Biomedica, Fiat, USA, Inc.1986-06-24
SARNS PORTABLE POWER MODULE (K861388)3M Health Care, Sarns1986-06-23
MEDNOVA BLOOD PRESSURE CUFF (K854813)Mednova Corp.1986-06-20
SUDS(HCG)CONTROL SET (URINE&SERUM) & HCG REF.SERUM (K862048)Murex Corp.1986-06-19
MODIFIED TELEFLEX MEDICAL INTRODUCER CATHETER (K861951)Teleflex, Inc.1986-06-19
MODIFY LABEL/PASYS & MOD 8316/17/18 IMPLAN PUL GEN (K862037)Medtronic Vascular1986-06-17
MODIFY LABEL/SPECTRAX S & SX IMPLANT PULSE GENER (K862038)Medtronic Vascular1986-06-17
MODIFIED LABEL FOR/SPECTRAX SXT IMPLANT. PULSE GEN (K862071)Medtronic Vascular1986-06-17
DISPOSABLE FLUSH DEVICE (K860681)Hewlett-Packard Co.1986-06-17
ERG 550 ERGOMETER BICYCLE (K854491)Robert Bosch Corp.1986-06-16
PHYSIO-DYNE ECG/HR 3 (K854847)Physio-Dyne Industrument Corp.1986-06-16
ERG 551 ERGOMETER, BICYCLE (K854492)Robert Bosch Corp.1986-06-16
ACS ROTATING HEMO VALVE - DUAL ACCESS TYPE (K861847)Advanced Cardiovascular Systems, Inc.1986-06-16
ERG 555 COUCH ERGOMETER (K854493)Robert Bosch Corp.1986-06-16
MODEL 486-02 ENDOCARDIAL PACING LEAD (K860547)Intermedics, Inc.1986-06-13
MODEL 492-02 ENDOCARDIAL PACING LEAD (K860548)Intermedics, Inc.1986-06-13
LIFESTAT 100 (K853561)Physio-Control Corp.1986-06-09
SCHNEIDER-SHILEY WIRE TORQUER (K861606)Shiley, Inc.1986-06-09
SCHNEIDER-SHILEY INFLATION SYRINGES (K861607)Shiley, Inc.1986-06-09
COLIN ELECTRONICS CO., LTD. STBP 680 (K854481)Colin Medical Instruments Corp.1986-06-09
MODEL 43200A CARDIAC MONITOR (K861992)Hewlett-Packard Co.1986-06-09
MICRO ANASTOMOSIS CLAMP (K861924)Pilling Co.1986-06-06
ENDOCARDIAL CARBON-TIP LEAD (K861481)Pacesetter Systems1986-06-06
SOFTWARE MODULE/2035 PROG AND ASTRA/T PULSE GEN (K860584)Cardiac Pacemakers, Inc.1986-06-06
MODEL 8604 OXYGEN/PULSE MONITOR (K860051)Nonin Medical, Inc.1986-06-05
PARAGON 420, CARDIAC MONITOR (K861067)Life Sensing Instrument Company, Inc.1986-06-05
INTRAVASCULAR CATHETER W/DOPPLER TRANSDUCER (K860121)NuMED, Inc.1986-06-02
THERMORITE MODEL HC-83 HYPO/HYPERTHERMIA UNIT (K854856)Thermorite, Inc.1986-06-02
INTERFACE CRYSTALLOID CARDIOPLEGIC FILTER MODEL 70 (K861226)Medical, Inc.1986-06-02
CRITICHEM CONTINUOUS BLOOD GAS MONTITOR, CVGM-1000 (K861277)Critichem, Inc.1986-06-02
CARDIOCAP MONITOR (K853953)Instrumentarium Corp.1986-06-02
HORIZON 2000 NON-INVASIVE BLOOD PRESSURE CAP. (K854942)Mennen Medical, Inc.1986-06-02
RMI POROUS VENT PLUG (K861322)Research Medical, Inc.1986-05-30
GAMBRO ULTRASONIC BLOOD LEVEL DETECTOR ULD 10-200 (K860076)Gambro, Inc.1986-05-30
STOCKERT-SHILEY AORTIC ROOT CANNULAE (K861310)Shiley, Inc.1986-05-30
ACS WHOLEY HI-TORQUE GUIDE WIRE (K861765)Advanced Cardiovascular Systems, Inc.1986-05-30
SARNS FILTERED CARDIOTOMY RESERVOIR (K860702)3M Health Care, Sarns1986-05-28
CPS-3000 CARDIOPLEGIA RESERVOIR (K861102)Gish Biomedical, Inc.1986-05-28
CAPIOX III CARDIOPULMONARY BYPASS OXYGENATOR (K861177)Terumo Medical Corp.1986-05-28
IMPLANT PROG PULSE GENERATOR, UNIPOLAR & BIPOLAR (K860573)Telectronics, Inc.1986-05-28
CAROTID BALLOON SHUNT (K860497)Imodex, Inc.1986-05-28
CAROTID BYPASS SHUNT (K860742)Clincal Instruments Corp.1986-05-28
ACS HI-TORQUE TAPERED DIAMETER GUIDE WIRE (K861574)Advanced Cardiovascular Systems, Inc.1986-05-28
CAROTID BYPASS SHUNT WITH SAMPLING ARM (K860743)Clincal Instruments Corp.1986-05-28
MEDIASTINAL AUTOTRANSFUSION SYSTEM (K860775)Cardio Metrics, Inc.1986-05-28
SCHNEIDER-SHILEY PRESSURE MANOMETER (K861605)Shiley, Inc.1986-05-28
TORAY ANTHRON BYPASS TUBES (K861116)Toray Industries (America), Inc.1986-05-28
CHEST DRAINAGE PACK, CDP-1000 (K861103)Gish Biomedical, Inc.1986-05-28
STOCKERT-SHILEY VENOUS CATH & AORTIC ARCH CANNULA (K861496)Shiley, Inc.1986-05-27
CARDIOPULMONARY CANNULA TUBING (K861096)Bio Medicus, Inc.1986-05-21
PC ARRHYTHMIA DETECTION/ANALYSIS - ARRHYTHMIA III (K860980)Spacelabs, Inc.1986-05-21
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