Gerard Medical Enterprises, Inc.

FDA Regulatory Profile

Summary

Total Recalls
0
510(k) Clearances
8
Inspections
0
Compliance Actions
0

Recent 510(k) Clearances

K-NumberDeviceDate
K954258TRIMPORT IMPLANTABLE ACCESS SYSTEM (MODIFICATION)May 24, 1996
K945250TRIMPORTMarch 7, 1995
K942623TRIMPORTAugust 23, 1994
K922147DUAL PLASTIC VASCULAR ACCESS SYSTEMDecember 4, 1992
K913114TRIM-PORT(TM) IMPLANT ACCESS SYST DUAL TITAN PORTJanuary 2, 1992
K912111MODIFIED VERSION IMPLANTABLE VASCULAR ACCESS SYSTEOctober 8, 1991
K903364GERARD MEDICAL, INC. TRIM-PORTOctober 31, 1990
K813358GERARD MEDICAL ELECTRODE TESTERDecember 29, 1981