American Edwards Laboratories - FDA 510(k) Cleared Devices
89
Total
88
Cleared
0
Denied
16 devices
Cleared
Oct 24, 1986
FLEXIBLE VISUALIZATION CATHETER
Gastroenterology & Urology
86d
Cleared
Oct 04, 1985
RIGID ENDOSCOPE
Gastroenterology & Urology
43d
Cleared
Aug 23, 1985
TROCAR/CANNULA/SHEATH SET
Gastroenterology & Urology
14d
Cleared
Aug 21, 1985
URETERAL DILATOR
Gastroenterology & Urology
83d
Cleared
Aug 09, 1985
URETERAL DILATOR/SHEATH SET
Gastroenterology & Urology
39d
Cleared
Apr 03, 1985
URETERAL DILATOR & URETERAL STONE DISLODGER
Gastroenterology & Urology
26d
Cleared
Mar 25, 1985
DIAFLEX OCCLUSION BALLOON CATHETER
Gastroenterology & Urology
27d
Cleared
Jan 15, 1985
NEPHROSTOMY GUIDEWIRE SHEATH
Gastroenterology & Urology
15d
Cleared
Jan 15, 1985
NEPHROSTOMY DRAINAGE CATHETER & STIFFENER
Gastroenterology & Urology
15d
Cleared
Dec 05, 1984
PERCUTANEOUS NEPHROSTOMY TROCAR SYS
Gastroenterology & Urology
44d
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
Apr 13, 1984
URETERAL DILATOR
Gastroenterology & Urology
85d
Cleared
Nov 29, 1983
COAXIAL BALLOON URETHRAL DILATOR
Gastroenterology & Urology
42d
Cleared
Jun 17, 1983
URETERAL STONE EXTRACTOR CATHETER
Gastroenterology & Urology
60d