Company ยท US
Gerard Medical Enterprises, Inc.
FDA 510(k) clearances and medical device recalls filed under this name, 1981 to 1996. Name variants (Inc, Corp, punctuation) are merged.
8510(k) clearances (0 in 12 months)
0recalls (0 in 12 months)
0recalls that name a 510(k)
Product codes
Latest 510(k) clearances
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| May 24, 1996 | K954258 | TRIMPORT IMPLANTABLE ACCESS SYSTEM (MODIFICATION) Gerard Medical Enterprises, Inc. | LJT |
| Mar 7, 1995 | K945250 | TRIMPORT Gerard Medical Enterprises, Inc. | LJT |
| Aug 23, 1994 | K942623 | TRIMPORT Gerard Medical Enterprises, Inc. | LJT |
| Dec 4, 1992 | K922147 | DUAL PLASTIC VASCULAR ACCESS SYSTEM Gerard Medical Enterprises, Inc. | LJT |
| Jan 2, 1992 | K913114 | TRIM-PORT(TM) IMPLANT ACCESS SYST DUAL TITAN PORT Gerard Medical Enterprises, Inc. | FMF |
| Oct 8, 1991 | K912111 | MODIFIED VERSION IMPLANTABLE VASCULAR ACCESS SYSTE Gerard Medical Enterprises, Inc. | FMF |
| Oct 31, 1990 | K903364 | GERARD MEDICAL, INC. TRIM-PORT Gerard Medical Enterprises, Inc. | LJT |
| Dec 29, 1981 | K813358 | GERARD MEDICAL ELECTRODE TESTER Gerard Medical Enterprises, Inc. | KRC |
Latest recalls
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| No recalls in this window. | |||