Dacomed Corp. - FDA 510(k) Cleared Devices
20
Total
20
Cleared
0
Denied
FDA 510(k) Regulatory Record - Dacomed Corp. Gastroenterology & Urology ✕
18 devices
Cleared
Oct 27, 1995
DUNA II PENILE PROSTHESIS
Gastroenterology & Urology
84d
Cleared
Aug 25, 1994
RIGISCAN PLUS RIGIDITY ASSESSMENT SYSTEM
Gastroenterology & Urology
136d
Cleared
May 11, 1992
DACOMED BATTERY OPERATED VACUUM ERECTION DEVICE
Gastroenterology & Urology
101d
Cleared
Apr 16, 1992
DURA II PENILE PROSTHESIS
Gastroenterology & Urology
76d
Cleared
Oct 11, 1991
MODIFIED DURAPHASE(TM) IMPLANTED PENILE PROSTHESIS
Gastroenterology & Urology
136d
Cleared
May 04, 1990
DACOMED NEGATIVE PRESSURE ERECTION DEVICE
Gastroenterology & Urology
73d
Cleared
Feb 08, 1989
DACOMED EXTERNAL MALE CONTINENCE DEVICE
Gastroenterology & Urology
42d
Cleared
Apr 27, 1988
DACOMED CYSTOMETER
Gastroenterology & Urology
89d
Cleared
Sep 18, 1987
DURAPHASE PENILE PROSTHESIS
Gastroenterology & Urology
143d
Cleared
Apr 09, 1985
OMNI PHASE PENILE PROSTHESIS
Gastroenterology & Urology
96d
Cleared
Jan 18, 1985
ESKA MULTISTAGE ESOPHAGEAL BOUGIE
Gastroenterology & Urology
158d
Cleared
Jul 06, 1984
DACOMED RIGISCAN SYSTEM
Gastroenterology & Urology
107d
Cleared
Feb 04, 1984
ESKA JONAS SILICON-SILVER PENILE
Gastroenterology & Urology
45d
Cleared
Oct 20, 1983
SILICONE-SILVER PENILE PROSTHESIS-ESK
Gastroenterology & Urology
230d
Cleared
Jul 18, 1983
DACOMED SNAP-GAUGE
Gastroenterology & Urology
18d
Cleared
Apr 21, 1982
DACOMED SNAP-GAUGE
Gastroenterology & Urology
44d
Cleared
Jan 25, 1982
ESKA JONAS SILICONE-SILVER PENILE PROST
Gastroenterology & Urology
13d
Cleared
Jun 26, 1981
FORDER RETRACTOR
Gastroenterology & Urology
11d