American Medical Systems, Inc. - FDA 510(k) Cleared Devices
72
Total
72
Cleared
0
Denied
72 devices
Cleared
Apr 18, 1994
NAMIC ARIA(TM) INFLATION DEVICE
Gastroenterology & Urology
70d
Cleared
Oct 28, 1992
120 FR OPTILUME PROSTATE BALLOON DILATOR
Gastroenterology & Urology
265d
Cleared
Oct 28, 1992
ENTRAC URETERAL BALLOON DILATION CATHETERS
Gastroenterology & Urology
194d
Cleared
May 06, 1992
ENTRAC URETHRAL BALLOON DILATATION CATHETER
Gastroenterology & Urology
78d
Cleared
Mar 20, 1992
ENTRAC(TM) URETHRAL MEASURING CATHETER
Gastroenterology & Urology
140d
Cleared
Mar 18, 1992
AMS SPHINCTER 800 URINARY PROSTHESIS
Gastroenterology & Urology
257d
Cleared
Mar 18, 1992
AMS MALLEABLE 600 AND 600M PENILE PROSTHESIS
Gastroenterology & Urology
257d
Cleared
Jun 27, 1990
700 ULTREX PENILE PROSTHESIS 12MM DIAMETER
Gastroenterology & Urology
90d
Cleared
May 17, 1990
AMS OPTILUME INFLATION SYRINGE
Gastroenterology & Urology
90d
Cleared
May 17, 1990
AMS OPTILUME(TM) PROSTATE BALLOON DILATOR
Gastroenterology & Urology
90d
Cleared
Mar 06, 1990
AMS DYNAFLEX SELF CONTAINED PENILE PROSTHESIS
Gastroenterology & Urology
83d
Cleared
Jun 17, 1988
1/2 CM REAR TIP EXTENDER (RTE)
Gastroenterology & Urology
15d
Cleared
Sep 05, 1985
URETERAL STENT
Gastroenterology & Urology
92d
Cleared
Jan 30, 1984
VERIFORM II
Cardiovascular
110d
Cleared
Aug 08, 1983
AMS MALLEABLE PENILE PROSTHESIS
Gastroenterology & Urology
77d
Cleared
Apr 12, 1983
INFLATABLE PENILE PROSTH. - CYLINDER
Gastroenterology & Urology
92d
Cleared
Aug 10, 1982
THE ARTIFICIAL URINARY SPHINCTER
Gastroenterology & Urology
69d
Cleared
Aug 10, 1982
THE INFLATABLE PENILE PROSTHESIS
Gastroenterology & Urology
69d
Cleared
Jul 30, 1982
TOMAC LUBRICATING JELLY
General Hospital
9d
Cleared
Apr 29, 1982
THERMO-K
Cardiovascular
36d
Cleared
Sep 09, 1980
AMS MALLEABLE OR JONAS SILICONE-SILVER
Gastroenterology & Urology
253d
Cleared
May 14, 1979
ULTRALITE UROSYSTEM, MODELS GU-1 & GU-2
Gastroenterology & Urology
59d