Edwards Pacemaker Systems is one of 5511 FDA 510(k) medical device manufacturers from United States in the dataset, ranked by real submission volume.
Edwards Pacemaker Systems - FDA 510(k) Cleared Devices
13
Total
13
Cleared
0
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.
FDA 510(k) Regulatory Record - Edwards Pacemaker Systems
13 devices
Cleared
Sep 26, 1979
EDWARDS PACEMAKER 30 UNIPOLAR GENERATOR
Cardiovascular
21d
Cleared
May 08, 1979
28 UNIPOLAR AND BIPOLAR PULSE GENERATORS
Cardiovascular
64d
Cleared
Aug 31, 1978
LEAD CONVERSION KIT, MODEL 341
Cardiovascular
59d
Cleared
Aug 23, 1978
ANALYZER, PACER SYSTEM, PSA-5
Cardiovascular
44d
Cleared
Jul 27, 1978
PROLITH 23S PACEMAKER
Cardiovascular
37d
Cleared
Jun 30, 1978
MICROPULSE 22S PACEMAKER
Cardiovascular
50d
Cleared
Mar 15, 1978
PACEMAKER, PROLITH 23U. PULSE GENERATOR
Cardiovascular
30d
Cleared
Jan 30, 1978
MICROPULSE 22U
Cardiovascular
14d
Cleared
Nov 02, 1977
MICROPULSE 26U PULSE GENERATOR
Cardiovascular
14d
Cleared
Apr 26, 1977
GENERATOR, PULSE, CARDIAC 20U
Cardiovascular
19d
Cleared
Apr 26, 1977
GENERATOR, PULSE, CARDIAC 2LU
Cardiovascular
19d
Cleared
Mar 09, 1977
PROLITH MODEL 21S CARDIAC PULSE GEN.
Cardiovascular
37d