Empi - FDA 510(k) Cleared Devices
60
Total
56
Cleared
0
Denied
FDA 510(k) Regulatory Record - Empi Gastroenterology & Urology ✕
10 devices
Cleared
Nov 03, 1998
SMALL VAGINAL/RECTAL ELECTRODE
Gastroenterology & Urology
50d
Cleared
Aug 14, 1997
INNOVA RECTAL REUSABLE ELECTRODE/COMFORTPULSE REGULAR OR SMALL REUSABLE...
Gastroenterology & Urology
73d
Cleared
Jun 30, 1997
INNOSENSE PELVIC FLOOR STIMULATION AND ELECTROMYOGRAPHY SYSTEM
Gastroenterology & Urology
63d
Cleared
Apr 22, 1997
MINNOVA PELVIC FLOOR STIMULATION SYSTEM
Gastroenterology & Urology
85d
Cleared
Jan 24, 1997
INNOVA COMFORTPULSE VAGINAL ELECTRODE (199204)/INNOVA COMFORTPULSE SMALL...
Gastroenterology & Urology
71d
Cleared
Apr 15, 1996
INNOVA RECTAL STIMULATON ELECTRODE
Gastroenterology & Urology
216d
Cleared
Dec 06, 1995
INNOVA RECTAL OR SMALL VAGINAL EMG SENSING ELECTRODE
Gastroenterology & Urology
177d
Cleared
Jan 20, 1995
INNOVA PELVIC FLOOR STIMULATION SYSTEM
Gastroenterology & Urology
276d
Cleared
Dec 29, 1994
INNOVA VAGINAL EMG SENSING ELECTRODE
Gastroenterology & Urology
356d
Cleared
Jul 15, 1991
TBD
Gastroenterology & Urology
187d