Rochester Medical Corp. - FDA 510(k) Cleared Devices
Recent clearances: HYDROSIL, HYDROPHILIC-ANTIBACTERIAL INTERMITTENT CATHETER, INTERMITTENT CATHETER CLOSED SYSTEM KIT, RELEASE NF ANTIBACTERIAL FOLEY CATHETER, ANTIBACTERIAL PERSONAL CATHETER
13
Total
13
Cleared
0
Denied
FDA 510(k) Regulatory Record - Rochester Medical Corp. Gastroenterology & Urology ✕
13 devices
Cleared
May 14, 2013
HYDROSIL
Gastroenterology & Urology
245d
Cleared
Jun 10, 2004
HYDROPHILIC-ANTIBACTERIAL INTERMITTENT CATHETER, INTERMITTENT CATHETER CLOSED...
Gastroenterology & Urology
220d
Cleared
Jul 07, 2000
RELEASE NF ANTIBACTERIAL FOLEY CATHETER, ANTIBACTERIAL PERSONAL CATHETER
Gastroenterology & Urology
88d
Cleared
May 19, 2000
HYDROPHILIC SILICONE FOLEY CATHETER AND PERSONAL CATHETER (HYDROPHILIC AND...
Gastroenterology & Urology
74d
Cleared
Jul 08, 1998
ALL SILICONE FOLEY CATHETER, TWO-WAY FOLEY CATHETER, THREE-WAY FOLEY...
Gastroenterology & Urology
63d
Cleared
Jan 13, 1998
SILICONE ANTIBACTERIAL FOLEY CATHETER
Gastroenterology & Urology
256d
Cleared
Mar 13, 1997
PERSONAL CATHETER
Gastroenterology & Urology
15d
Cleared
Jul 18, 1995
ROCHESTER MEDICAL CORPORATION SILICONE MALE EXTERNAL CATHETER
Gastroenterology & Urology
76d
Cleared
Mar 06, 1995
FEMALE LENGTH ALL SILICONE UROLOGICAL CATHETER
Gastroenterology & Urology
334d
Cleared
Jan 31, 1995
ALL SILICONE INTERMITTENT CATHETER
Gastroenterology & Urology
176d
Cleared
Dec 03, 1992
MALE EXTERNAL CATHETER
Gastroenterology & Urology
157d
Cleared
Jan 18, 1991
COMFORT SLEEVED ALL SILICONE FOLEY CATHETER
Gastroenterology & Urology
72d