Medical Device Manufacturer · US , Rochester , MN

Rochester Medical Corp. - FDA 510(k) Cleared Devices

13 submissions · 13 cleared · Since 1990
13
Total
13
Cleared
0
Denied

Rochester Medical Corp. — FDA 510(k) Products and Clearance History Gastroenterology & Urology

13 devices
1-13 of 13
Cleared May 14, 2013
HYDROSIL
K122785 · EZD
Gastroenterology & Urology · 245d
Cleared Jun 10, 2004
HYDROPHILIC-ANTIBACTERIAL INTERMITTENT CATHETER, INTERMITTENT CATHETER CLOSED...
K033477 · MJC
Gastroenterology & Urology · 220d
Cleared Jul 07, 2000
RELEASE NF ANTIBACTERIAL FOLEY CATHETER, ANTIBACTERIAL PERSONAL CATHETER
K001143 · MJC
Gastroenterology & Urology · 88d
Cleared May 19, 2000
HYDROPHILIC SILICONE FOLEY CATHETER AND PERSONAL CATHETER (HYDROPHILIC AND...
K000723 · KOD
Gastroenterology & Urology · 74d
Cleared Jul 08, 1998
ALL SILICONE FOLEY CATHETER, TWO-WAY FOLEY CATHETER, THREE-WAY FOLEY...
K981612 · EZL
Gastroenterology & Urology · 63d
Cleared Jan 13, 1998
SILICONE ANTIBACTERIAL FOLEY CATHETER
K971627 · MJC
Gastroenterology & Urology · 256d
Cleared Mar 13, 1997
PERSONAL CATHETER
K970704 · GBM
Gastroenterology & Urology · 15d
Cleared Jul 18, 1995
ROCHESTER MEDICAL CORPORATION SILICONE MALE EXTERNAL CATHETER
K952082 · EXJ
Gastroenterology & Urology · 76d
Cleared Mar 06, 1995
FEMALE LENGTH ALL SILICONE UROLOGICAL CATHETER
K941692 · EZL
Gastroenterology & Urology · 334d
Cleared Jan 31, 1995
ALL SILICONE INTERMITTENT CATHETER
K943851 · GBM
Gastroenterology & Urology · 176d
Cleared Dec 03, 1992
MALE EXTERNAL CATHETER
K923136 · EXJ
Gastroenterology & Urology · 157d
Cleared Jan 18, 1991
COMFORT SLEEVED ALL SILICONE FOLEY CATHETER
K905042 · EZL
Gastroenterology & Urology · 72d
Cleared Feb 12, 1990
ALL SILICONE FOLEY CATHETER
K896053 · KOD
Gastroenterology & Urology · 117d
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