Baxter Edwards is one of 21639 FDA 510(k) medical device manufacturers from United States in the dataset, ranked by real submission volume.
Baxter Edwards - FDA 510(k) Cleared Devices
Recent clearances: BAXTER PERCUTANEOUS MECHANICAL THROMBECTOMY (PMT) DEVICE, MODELS PMT0606FD AND PMT1206FD, BAXTER HEMOSTASIS VALVE INTRODUCERS, CARPENTER-EDWARDS CLASSIC RING WITH DURAFLO TREATMENT MODELS 4425 (MITRAL) AND 4525 (TRICUSPID), CARPENTER-EDWARDS PHYSM
11
Total
10
Cleared
0
Denied
Baxter Edwards has 10 FDA 510(k) cleared cardiovascular devices. Based in Irvine, US.
Historical record: 10 cleared submissions from 1993 to 2000.
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 - Baxter Edwards
11 devices
Cleared
May 04, 2000
BAXTER PERCUTANEOUS MECHANICAL THROMBECTOMY (PMT) DEVICE, MODELS PMT0606FD...
Cardiovascular
176d
Cleared
Nov 24, 1998
BAXTER HEMOSTASIS VALVE INTRODUCERS
Cardiovascular
176d
Cleared
Jul 07, 1998
CARPENTER-EDWARDS CLASSIC RING WITH DURAFLO TREATMENT MODELS 4425 (MITRAL)...
Cardiovascular
148d
Cleared
Jun 04, 1997
FOGARTY VALVULOTOME MODEL 700091
Cardiovascular
163d
Cleared
Mar 27, 1997
INTRAMED SIDE BRANCH OCCLUSION (SBO) SYSTEM (700095 AND 700099)
Neurology
171d
Cleared
Mar 25, 1996
MULTI-MED MULTI-LUMEN CENTRAL VENOUS CATHETER
General Hospital
90d
Cleared
Jul 28, 1995
4.5F IMAGECATH CORONARY ANGIOSCOPE, MODEL COV45 [SUBSEQUENTLY REFERRED TO AS...
Cardiovascular
49d
Cleared
Feb 10, 1995
BAXTER HANDLE MODEL 1150
Cardiovascular
165d
Cleared
Jan 05, 1995
BAXTER EPTFE EXTERNALLY SUPPORTED VASCULAR GRAFTS
Cardiovascular
94d
Cleared
May 24, 1994
SWAN-GANZ CC0/SVO2 THERMODILUTION CATHETER
Cardiovascular
91d
Cleared
Mar 23, 1993
4.5F IMAGECATH(R) CORONARY ANGIOSCOPE, COV45
Cardiovascular
90d