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Cardiovascular

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

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RecordFirmDate
PULSE GENERATOR, MODEL 240, EXTERNAL (K781327)Intermedics, Inc.1978-12-11
PACING MODELS MUM 860, MUM 890 (K781623)R.E. Brown Co., Inc.1978-12-08
PACING LEAD ADAPTER MODEL ACS 16 (K781622)R.E. Brown Co., Inc.1978-12-08
PACING LEAD MODELS, MAM 1260 MAM 1290 (K781621)R.E. Brown Co., Inc.1978-12-08
PACING LEAD MODEL MVM 860, MVM 890 (K781625)R.E. Brown Co., Inc.1978-12-08
PACING LEAD ADAPTER, ACV 14, ACV 23 (K781626)R.E. Brown Co., Inc.1978-12-08
PACING LEAD MODELS SA, 350, SAM 500 (K781619)R.E. Brown Co., Inc.1978-12-08
PACING LEAD MODELS, MDM 1060, MDM 1090 (K781620)R.E. Brown Co., Inc.1978-12-08
PACING LEAD ADAPTER MODEL ADB 21 (K781627)R.E. Brown Co., Inc.1978-12-08
PACEMAKER, MODEL 229-01 (K781738)Intermedics, Inc.1978-12-07
GENERATOR, PULSE, SORIN MODEL DL-1 (K780897)Bentley Laboratories, Inc.1978-12-06
MONITOR, NON-INVASIVE BLOOD PRESSURE (K782000)Automated Screening Devices1978-12-05
CHAMBER, MC-1 DISPOSABLE PRESSURE (K781890)Delta Medical Industries1978-12-04
BLOOD PRESSURE, DIGITAL MODEL #2153 (K781701)Sears, Roebuck & Co.1978-12-04
CARDIAC INSULATION PAD (K781990)Shiley, Inc.1978-12-04
ELECTRODES, IMPLANTABLE WITH ADAPTER (K781849)Telectronics, Inc.1978-12-04
PAD, COOLING #27-999 (K781764)Cobe Laboratories, Inc.1978-12-04
OVALITH 10BP (K781377)Coratomic, Inc.1978-12-04
TEMPORARY CARDIAC PACING WIRE (K781002)ETHICON, Inc.1978-12-04
TELEMETRY SYSTEM, BIOTEL 300 (K781836)Spacelabs, Inc.1978-12-04
UNIPOPLAR ENDOCARDIAL LEADS (K781326)American Technology, Inc.1978-12-04
ENDOCARDIAL BIPOLAR LEAD (K781456)American Technology, Inc.1978-12-04
ECG ANALYZER, HIGH SPEED (K781911)Cardio-Dynamics Laboratories, Inc.1978-11-30
BLOOD PRESSURE RECORDER (K781932)Cardiodyne, Inc.1978-11-29
CALIBRATOR, DYNAMIC (K781692)Waters Assoc., Inc.1978-11-29
EKG ELECTRODES, DISPOSABLE (K781940)Hayes Products, Inc.1978-11-29
CATHETER INTRODUCERS, ARTERISE (K781954)C.R. Bard, Inc.1978-11-29
DELTA-FLOW (K780479)Tri-Delta Intl.1978-11-22
CAMSCAN SYSTEM (K781845)American Optical Corp.1978-11-20
BLOOD PRESSURE DEVICE, 400 SERIES (K781906)Med-Tek Corp.1978-11-16
BLOOD PRESSURE CUFF COVER (K781671)David Cott Co.1978-11-16
FILTER, EXTRACORPOREAL BLOOD HOLDER (K781861)Surgikos, Inc.1978-11-15
OXYGENATOR, BLOOD BOS-10 (K781842)Bentley Laboratories, Inc.1978-11-08
ANGIOGRAPHIC GUIDE WIRE (K781561)Wilson Medical Instruments Co.1978-11-07
RECORDER, HOLTER ELECTROCARDIOGRAM (K781843)Hovik Corp.1978-11-03
PREGELLED DISPOSABLE E.K.G. ELECTRODE (K781430)Vermont Medical, Inc.1978-10-31
VARIABLE STIFFNESS WIRE GUIDE (K781393)Cook, Inc.1978-10-30
PACING LEADS MODEL UL-811 AND UL-813 (K781776)Pacesetter Systems1978-10-27
STRAIN GAUGE PLETHYSMOGRAPH (K781352)Medimatic1978-10-27
FILTER, ARTERIAL BLOOD W/TUBING BYPASS (K781707)Surgikos, Inc.1978-10-26
PRESSURE INFUSION CUFF (K781556)Abbott Laboratories1978-10-17
ECG ELECTRODE, 2021, 2022, 2032, 2033 (K781514)Cardio-Dynamics Laboratories, Inc.1978-10-17
MONITOR, HEART RATE (K781166)Cybernetic Medical, Inc.1978-10-15
SURGITEK DISPOSABLE FLO-RESTER (K781336)Medical Engineering Corp.1978-10-10
HEAT EXCHANGER, FHX-14 (K781210)Delta Medical Industries1978-10-10
PRESSURE MONITORING INJECTION LINES (K781558)Cobe Laboratories, Inc.1978-10-10
PREGELLED DISPOSABLE ELECTRODE (K781518)Vente Medical Products, Inc.1978-10-06
MONITORING, PRESSURE KIT (K781680)Pharmaseal Div., Baxter Healthcare Corp.1978-10-06
PRINTER, DIGITAL (K781115)Output, Inc.1978-10-06
MODIFIED STERILE DISPOSABLE STOPCOCKS (K781579)Cobe Laboratories, Inc.1978-10-05
GENERATOR, PULSE, MODEL 5997 (K781252)Medtronic Vascular1978-10-03
GENERATORS, PULSE, MODELS 5988/5989 (K781208)Medtronic Vascular1978-10-03
ARCOBIOLITH PACEMAKER MODEL (K780776)Arco Medical Products Co.1978-10-03
GENERATORS: UDL-201B, BDL-201B, MDL-201B (K781424)Pacesetter Systems1978-09-27
ERM-101 (K781407)Cynergy1978-09-27
DISPOSABLE CARDIOTOMY; H-700F, H-700 (K781577)C.R. Bard, Inc.1978-09-27
GENERATOR, PULSE, MODEL 160B (K780940)Telectronics, Inc.1978-09-27
PACEMAKER, MODEL 225 & 227 (K772226)Intermedics, Inc.1978-09-27
INTERFACE CARDIOTOMY BLOOD FILTER (K781383)Medical, Inc.1978-09-27
ELECTRODE, DEIP. (K781163)Datascope Corp.1978-09-26
CATHODE RAY TUBE MED. DISPLAY (K781256)Rae Medical Corp.1978-09-20
T.E.D. SEQUENTIAL COMPRESSION SLEEVES (K781357)Kendall Research Center1978-09-20
INSTA-PULSE HEART RATE MONITOR (K781387)Bio Sig Instruments, Inc.1978-09-20
CARDIOPNEUMOGRAPH (K781292)Street Electronics Corp.1978-09-20
SEQUENTIAL CUFF INFLATION DEVICE (K781358)Medasonics, Inc.1978-09-20
DIGITAL PANEL METER (K781255)Rae Medical Corp.1978-09-20
AC ADAPTER:MODELS 9525,9526,9527 (K781535)Edwards Laboratories1978-09-15
OXYGENATOR, BUBBLE TYPE (K780078)Bentley Laboratories, Inc.1978-09-14
DINAMAP MODEL 848 (K781064)Applied Medical Research1978-09-07
CARDIAL PULSE GENERATORS (K781426)Telectronics, Inc.1978-09-07
MASK, PXYGEN (K781413)Vitalab Products Corp.1978-09-07
DINAMAP MODEL 846 (K781053)Applied Medical Research1978-09-07
GENERATOR, CARDIAC PULSE, 250B (K781090)Telectronics, Inc.1978-09-07
PULSE GENERATOR MODEL 208 (K781178)Elema-Schonander, Inc.1978-09-07
GENERATOR, PULSE, PACEMAKER (K781168)Vitatron Medical BV1978-08-31
PACER-TRACER PULSE WIDTH (K781349)Instromedix, Inc.1978-08-31
MODEL 1861 BLOOD PUMP (K780953)Medtronic Vascular1978-08-31
ELECTROCARDIOGRAPHIC ECG RECORDER (K781152)Cardio-Dynamics Laboratories, Inc.1978-08-31
MODEL 20 DIGITAL PULSE RATE MONITOR (K780937)Sentronix, Inc.1978-08-31
PACEMAKER, ELECTRODE, PERMANENT & TEMP. (K780246)Daig Corp.1978-08-31
MODEL 1812 CONTROL CONSOLE, ACCESSORIEX (K780952)Medtronic Vascular1978-08-31
DILUTION KIT, THERMAL, COLD PAC (K781221)Instrumentation Laboratory CO1978-08-23
ANALYZER, PACER SYSTEM, PSA-5 (K781144)Edwards Pacemaker Systems1978-08-23
DISPOSABLE SYRINGE FILL TUBE (K781334)Mallinckrodt Group, Inc.1978-08-17
CATHETER, THERMAL DILUTION FIBEROPTIC (K781134)Oximetrix, Inc.1978-08-17
GENERATOR, PULSE, DEMAND, MODEL 5996 (K780741)Medtronic Vascular1978-07-28
BIPOLAR ENDOCARDIAL PACING LEAD, M. 6902 (K780622)Medtronic Vascular1978-07-28
GENERATOR, PULSE MODELS 5920/5921 (K780809)Medtronic Vascular1978-07-28
ENDOCARDIAL ATRIAL PACING LEAD, M. 6994 (K780623)Medtronic Vascular1978-07-28
MONITOR KITS, BLOOD LEVEL (K781145)3M Health Care, Sarns1978-07-27
GENERATOR, PULSE, CARDIAC, IMPLANTABLE (K780420)Telectronics, Inc.1978-07-27
PROLITH 23S PACEMAKER (K781042)Edwards Pacemaker Systems1978-07-27
WRENCH, GEXAGON, DRIVER (K781179)Telectronics, Inc.1978-07-27
VENTRICULAR INHIBITED PULSE GENERATOR (K780561)Medtronic Vascular1978-07-27
OXYGENATOR, BLOOD, INFANT/PEDIATRIC (K781223)Shiley, Inc.1978-07-27
STILITH CARDIAC PACEMAKERS-M. 60 & 120 (K780781)R.E. Brown Co., Inc.1978-07-27
LIFELINE AMBULATORY (K781054)Imc1978-07-27
LEAD, PACING, ATRIAL, ENDOCARDIAL, TINED (K780621)Medtronic Vascular1978-07-26
DIGITAL BLOOD PRESSURE MONITOR (K780986)Sears, Roebuck & Co.1978-07-18
PENTAX ST-1A (K780738)Hal-Hen Co., Inc.1978-07-17
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