Dacomed Corp. - FDA 510(k) Cleared Devices

Cleared Oct 27, 1995

DUNA II PENILE PROSTHESIS

K953640 · FAE

Gastroenterology & Urology · 84d

Cleared Aug 25, 1994

RIGISCAN PLUS RIGIDITY ASSESSMENT SYSTEM

K941781 · LIL

Gastroenterology & Urology · 136d

Cleared May 11, 1992

DACOMED BATTERY OPERATED VACUUM ERECTION DEVICE

K920409 · LKY

Gastroenterology & Urology · 101d

Cleared Apr 16, 1992

DURA II PENILE PROSTHESIS

K920420 · FAE

Gastroenterology & Urology · 76d

Cleared Oct 11, 1991

MODIFIED DURAPHASE(TM) IMPLANTED PENILE PROSTHESIS

K912344 · FAE

Gastroenterology & Urology · 136d

Cleared May 04, 1990

DACOMED NEGATIVE PRESSURE ERECTION DEVICE

K900774 · LKY

Gastroenterology & Urology · 73d

Cleared Feb 08, 1989

DACOMED EXTERNAL MALE CONTINENCE DEVICE

K885323 · FHA

Gastroenterology & Urology · 42d

Cleared Apr 27, 1988

DACOMED CYSTOMETER

K880391 · EXQ

Gastroenterology & Urology · 89d

Cleared Sep 18, 1987

DURAPHASE PENILE PROSTHESIS

K871653 · FAE

Gastroenterology & Urology · 143d

Cleared Apr 09, 1985

OMNI PHASE PENILE PROSTHESIS

K850019 · FAE

Gastroenterology & Urology · 96d

Cleared Jan 18, 1985

ESKA MULTISTAGE ESOPHAGEAL BOUGIE

K843186 · FAT

Gastroenterology & Urology · 158d

Cleared Jul 06, 1984

DACOMED RIGISCAN SYSTEM

K841202 · LIL

Gastroenterology & Urology · 107d