Panels › General, Plastic Surgery › Product code GFI · Class 1
Osteotome, Manual
Regulation 878.4800
0510(k)s in 12 months (6 all time)
0recalls in 12 months (0 all time)
0recalls that name a 510(k)
Top companies in GFI
| Company | 510(k)s | Recalls |
|---|---|---|
| Biomerieux Vitek, Inc. | 1 | 0 |
| Cher Mel Corp. | 1 | 0 |
| Innovative Surgical, Inc. | 1 | 0 |
| Storz Instrument Co. | 1 | 0 |
| Valleylab, Inc. | 1 | 0 |
| Zinnanti Surgical Instruments, Inc. | 1 | 0 |
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Nov 2, 1993 | K933181 | VALLEYLAB FORCE GSU HANDSET ADAPTER MODEL #E0500 Valleylab, Inc. | GFI |
| Aug 19, 1993 | K932534 | ISI FENESTRATED DISSECTING AND GRASPING FORCEPS Innovative Surgical, Inc. | GFI |
| Sep 25, 1992 | K920001 | HEMOLAB SILIMAT REAGENT Biomerieux Vitek, Inc. | GFI |
| Apr 12, 1989 | K891887 | OSTEOTOMES, VARIOUS TYPES Zinnanti Surgical Instruments, Inc. | GFI |
| Jul 11, 1985 | K852541 | STORZ ION BOND OSTEOTOMES & RASPS, FAST CU BURS Storz Instrument Co. | GFI |
| Aug 2, 1984 | K842823 | CHERMEL OSTEOTOMES Cher Mel Corp. | GFI |
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