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Dacomed Corp.

FDA Regulatory Profile

Summary

Total Recalls
0
510(k) Clearances
20
Inspections
0
Compliance Actions
0

Recent 510(k) Clearances

K-NumberDeviceDate
K953640DUNA II PENILE PROSTHESISOctober 27, 1995
K941781RIGISCAN PLUS RIGIDITY ASSESSMENT SYSTEMAugust 25, 1994
K920409DACOMED BATTERY OPERATED VACUUM ERECTION DEVICEMay 11, 1992
K920420DURA II PENILE PROSTHESISApril 16, 1992
K912344MODIFIED DURAPHASE(TM) IMPLANTED PENILE PROSTHESISOctober 11, 1991
K900774DACOMED NEGATIVE PRESSURE ERECTION DEVICEMay 4, 1990
K885323DACOMED EXTERNAL MALE CONTINENCE DEVICEFebruary 8, 1989
K880391DACOMED CYSTOMETERApril 27, 1988
K871653DURAPHASE PENILE PROSTHESISSeptember 18, 1987
K870320DACOMED PENILE PROSTHESIS SIZERMarch 17, 1987
K854118DACOMED CORP. ESKA-HERRMAN VOICE PROSTHESISMarch 17, 1986
K850019OMNI PHASE PENILE PROSTHESISApril 9, 1985
K843186ESKA MULTISTAGE ESOPHAGEAL BOUGIEJanuary 18, 1985
K841202DACOMED RIGISCAN SYSTEMJuly 6, 1984
K834504ESKA JONAS SILICON-SILVER PENILEFebruary 4, 1984
K830667SILICONE-SILVER PENILE PROSTHESIS-ESKOctober 20, 1983
K832121DACOMED SNAP-GAUGEJuly 18, 1983
K820615DACOMED SNAP-GAUGEApril 21, 1982
K820081ESKA JONAS SILICONE-SILVER PENILE PROSTJanuary 25, 1982
K811693FORDER RETRACTORJune 26, 1981