Sulzer Carbomedics, Inc. is one of 5511 FDA 510(k) medical device manufacturers from United States in the dataset, ranked by real submission volume.
Sulzer Carbomedics, Inc. - FDA 510(k) Cleared Devices
8
Total
8
Cleared
0
Denied
Sulzer Carbomedics, Inc. has 8 FDA 510(k) cleared medical devices. Based in Austin, US.
Historical record: 8 cleared submissions from 1998 to 2002. Primary specialty: Cardiovascular.
Browse the FDA 510(k) cleared devices submitted by Sulzer Carbomedics, Inc. Filter by specialty or product code using the sidebar.
FDA 510(k) Regulatory Record - Sulzer Carbomedics, Inc.
8 devices
Cleared
Dec 17, 2002
ANNULOFLEX ANNUOPLASTY SYSTEM, MODEL AF 800
Cardiovascular
84d
Cleared
Jun 13, 2002
SULZER VASCUTEK GELWEAVE VALSALVA VASCULAR PROSTHESIS
Cardiovascular
279d
Cleared
Apr 23, 2002
ANNULOFLO SYSTEM, MITRAL MODEL AR700
Cardiovascular
22d
Cleared
Jan 25, 2001
SULZER VASCUTEK GELSOFT ERS VASCULAR PROSTHESIS
Cardiovascular
206d
Cleared
Dec 29, 1999
SULZER CARBOMEDICS CARDIOFIX PERICARDIUM
Cardiovascular
89d
Cleared
Oct 12, 1999
ANNULOFLEX ANNULOPLASTY SYSTEM, MODEL AF800
Cardiovascular
116d
Cleared
Aug 04, 1998
SULZER CARBOMEDICS LOW PROFILE MITRAL ROTATOR
Cardiovascular
235d
Cleared
Apr 14, 1998
PATCH,PLEDGET AND INTRACARDIAC,PETP,PTFE,POLYPROPYLENE
Cardiovascular
307d