Medical Device Manufacturer · US , Mchenry , IL

Edwards Pacemaker Systems - FDA 510(k) Cleared Devices

13 submissions · 13 cleared · Since 1977

Total

Cleared

Denied

Edwards Pacemaker Systems has 13 FDA 510(k) cleared cardiovascular devices. Based in Mchenry, US.

Historical record: 13 cleared submissions from 1977 to 1979.

Browse the complete list of FDA 510(k) cleared cardiovascular devices from this manufacturer. Filter by specialty or product code using the sidebar.

Edwards Pacemaker Systems is one of 5511 FDA 510(k) medical device manufacturers from United States in the dataset, ranked by real submission volume.

FDA 510(k) Regulatory Record - Edwards Pacemaker Systems

13 devices

1-13 of 13

Cleared Sep 26, 1979

EDWARDS PACEMAKER 30 UNIPOLAR GENERATOR

K791751 · DXY

Cardiovascular · 21d

Cleared May 08, 1979

28 UNIPOLAR AND BIPOLAR PULSE GENERATORS

K790452 · DXY

Cardiovascular · 64d

Cleared Aug 31, 1978

LEAD CONVERSION KIT, MODEL 341

K781111

Cardiovascular · 59d

Cleared Aug 23, 1978

ANALYZER, PACER SYSTEM, PSA-5

K781144 · DTC

Cardiovascular · 44d

Cleared Jul 27, 1978

PROLITH 23S PACEMAKER

K781042 · DXY

Cardiovascular · 37d

Cleared Jun 30, 1978

MICROPULSE 22S PACEMAKER

K780780 · DXY

Cardiovascular · 50d

Cleared Mar 15, 1978

PACEMAKER, PROLITH 23U. PULSE GENERATOR

MICROPULSE 26U PULSE GENERATOR

K771987 · DXY

Cardiovascular · 14d

Cleared Apr 26, 1977

GENERATOR, PULSE, CARDIAC 20U

K770656 · DXY

Cardiovascular · 19d

Cleared Apr 26, 1977

GENERATOR, PULSE, CARDIAC 2LU

K770657 · DXY

Cardiovascular · 19d

Cleared Mar 09, 1977

PROLITH MODEL 21S CARDIAC PULSE GEN.

Edwards Pacemaker Systems - FDA 510(k) Cleared Devices

FDA 510(k) Regulatory Record - Edwards Pacemaker Systems

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