Shiley, Inc. - FDA 510(k) Cleared Devices
174
Total
174
Cleared
0
Denied
120 devices
Cleared
Feb 02, 1981
IONESCU-SHILEY AORTIC GRAFT VALVE
Cardiovascular
69d
Cleared
Dec 19, 1980
BUCKBERG-SHILEY BLOOD CARDIOPLEGIC SPL.
Cardiovascular
32d
Cleared
Dec 16, 1980
PUIG MASSANA-SHILEY ANNULOPLASTY RING
Cardiovascular
132d
Cleared
Sep 16, 1980
SHILEY UTILITY RESERVOIR
Cardiovascular
12d
Cleared
Aug 13, 1980
IONESCU-SHILEY PERICARDIAL PATCH
Cardiovascular
16d
Cleared
Jul 14, 1980
SHILEY CARDIOTOMY RESERVOIR W/FILTER
Cardiovascular
33d
Cleared
Dec 04, 1979
BONCHEK-SHILEY VEIN DISTENTION SYSTEM
Cardiovascular
43d
Cleared
Nov 13, 1979
SHILEY CARDIOPLEGIC SOLUTION DEL SETS
Cardiovascular
43d
Cleared
Oct 02, 1979
SHILEY QUICK DISCONNECT ASSEMBLY
Cardiovascular
15d
Cleared
Sep 27, 1979
BJORK-SHILEY PULMONIC GRAFT VALVE
Cardiovascular
10d
Cleared
Aug 10, 1979
BJORK-SHILEY AORTIC GRAFT VALVE PROSTH
Cardiovascular
38d
Cleared
Jun 13, 1979
SAPHENOUS VEIN IRRIGATION, PRESSURIZATIO
Cardiovascular
26d
Cleared
Jun 11, 1979
ARTERIAL EMBOLECTOMY CATHETER (MODIFIED)
Cardiovascular
41d
Cleared
Mar 28, 1979
IONESCU-SHILEY COMPOSITE CONDUIT-PULMONI
Cardiovascular
26d
Cleared
Dec 04, 1978
CARDIAC INSULATION PAD
Cardiovascular
7d
Cleared
Sep 01, 1978
BJORK-SHILEY CARDIAC HEART VALVE
Cardiovascular
120d
Cleared
Jul 27, 1978
OXYGENATOR, BLOOD, INFANT/PEDIATRIC
Cardiovascular
10d
Cleared
May 26, 1978
EMBOLECTOMY CATHETER, EXTEND. SHELF LIFE
Cardiovascular
18d
Cleared
Dec 13, 1977
OXYGENATOR, BUBBLE
Cardiovascular
5d
Cleared
Jan 14, 1977
CARDIOTOMY RESERVOIR
Cardiovascular
4d
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