American Edwards Laboratories - FDA 510(k) Cleared Devices
89
Total
88
Cleared
0
Denied
89 devices
Cleared
Mar 25, 1985
DIAFLEX OCCLUSION BALLOON CATHETER
Gastroenterology & Urology
27d
Cleared
Feb 15, 1985
HOME PRO VOLUMETRIC INFUSION PUMP
General Hospital
318d
Cleared
Jan 15, 1985
RIGHT VENTRICULAR EJECTION FRACTION-
Cardiovascular
235d
Cleared
Jan 15, 1985
NEPHROSTOMY GUIDEWIRE SHEATH
Gastroenterology & Urology
15d
Cleared
Jan 15, 1985
NEPHROSTOMY DRAINAGE CATHETER & STIFFENER
Gastroenterology & Urology
15d
Cleared
Jan 14, 1985
SAT-1 OXIMETER/CARDIAC OUTPUT COMPUTER
Cardiovascular
286d
Cleared
Dec 05, 1984
PERCUTANEOUS NEPHROSTOMY TROCAR SYS
Gastroenterology & Urology
44d
Cleared
Nov 05, 1984
AMER. EDWARDS LAB FLEXISCOPE
Ophthalmic
139d
Cleared
Nov 01, 1984
PERICARDIAL PATCH
Cardiovascular
372d
Cleared
Oct 19, 1984
MODULAR VOLUMETRIC INFUSION PUMP SYS
General Hospital
60d
Cleared
Oct 18, 1984
AMERICAN EDWARDS MINI-FLEX ANGIOSCOPE
Cardiovascular
115d
Cleared
Oct 02, 1984
DIAFLEX NEPHROSTOMY BALLOON DILATOR
Gastroenterology & Urology
120d
Cleared
Oct 02, 1984
DILATOR/SHEATH SET
Gastroenterology & Urology
88d
Cleared
Oct 02, 1984
AMER. EDWARDS LAB DIAFLEX URETERAL DILA
Gastroenterology & Urology
85d
Cleared
Aug 18, 1984
AMERICAN EDWARDS LABS FLEXISCOPE
Orthopedic
121d
Cleared
Aug 17, 1984
AMER. EDWARDS LAB FLEXISCOPE OBTURATOR
Orthopedic
65d
Cleared
Aug 10, 1984
PERIPHERAL DILATATION ANGIOPLASTY-CATH
Cardiovascular
239d
Cleared
Aug 10, 1984
INTRAOPERATIVE ANGIOSCOPE DELIVERY CATH
Cardiovascular
24d
Cleared
Aug 10, 1984
PERCUTANEOUS ANGIOSCOPE DELIVERY CATH
Cardiovascular
24d
Cleared
Jul 13, 1984
ACCUPRO VOLUMETRIC INFUSION PUMP W/RS232
General Hospital
64d
Cleared
Jun 11, 1984
ANGIOSCOPY CATHETER
Cardiovascular
167d
Cleared
Apr 17, 1984
CO-SET
General & Plastic Surgery
148d
Cleared
Apr 13, 1984
URETERAL DILATOR
Gastroenterology & Urology
85d
Cleared
Feb 04, 1984
DIAGNOSTIC RADIOLOGY CATHETERS
Cardiovascular
47d
Cleared
Jan 27, 1984
HYBRID PERIPHERAL DILATION CATHETER
Cardiovascular
53d
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