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Rochester Medical Corp.

FDA Regulatory Profile

Summary

Total Recalls
0
510(k) Clearances
13
Inspections
2
Compliance Actions
0

Recent 510(k) Clearances

K-NumberDeviceDate
K122785HYDROSIL; MAGIC; PERSONAL CATHETERMay 14, 2013
K033477HYDROPHILIC-ANTIBACTERIAL INTERMITTENT CATHETER, INTERMITTENT CATHETER CLOSED SYSTEM KITJune 10, 2004
K001143RELEASE NF ANTIBACTERIAL FOLEY CATHETER, ANTIBACTERIAL PERSONAL CATHETERJuly 7, 2000
K000723HYDROPHILIC SILICONE FOLEY CATHETER AND PERSONAL CATHETER (HYDROPHILIC AND NON-HYDROPHILIC)May 19, 2000
K981612ALL SILICONE FOLEY CATHETER, TWO-WAY FOLEY CATHETER, THREE-WAY FOLEY CATHETER, TWO-WAY RADIOPAQUE FOJuly 8, 1998
K971627SILICONE ANTIBACTERIAL FOLEY CATHETERJanuary 13, 1998
K970704PERSONAL CATHETERMarch 13, 1997
K952082ROCHESTER MEDICAL CORPORATION SILICONE MALE EXTERNAL CATHETERJuly 18, 1995
K941692FEMALE LENGTH ALL SILICONE UROLOGICAL CATHETERMarch 6, 1995
K943851ALL SILICONE INTERMITTENT CATHETERJanuary 31, 1995
K923136MALE EXTERNAL CATHETERDecember 3, 1992
K905042COMFORT SLEEVED ALL SILICONE FOLEY CATHETERJanuary 18, 1991
K896053ALL SILICONE FOLEY CATHETERFebruary 12, 1990