Panels › General, Plastic Surgery › Product code GFF · Class 1
Bur, Surgical, General & Plastic Surgery
Regulation 878.4820
0510(k)s in 12 months (16 all time)
0recalls in 12 months (13 all time)
4recalls that name a 510(k)
Top companies in GFF
| Company | 510(k)s | Recalls |
|---|---|---|
| The Anspach Effort, Inc. | 1 | 3 |
| Micro-Aire Surgical Instruments, Inc. | 4 | 0 |
| Acumed Instruments Corp. | 1 | 0 |
| American Medical Specialties, Inc. | 1 | 0 |
| Arthrex, Inc. | 0 | 1 |
| Brasseler USA I Lp | 0 | 1 |
| ConMed Corporation | 0 | 1 |
| Danek Medical, Inc. | 1 | 0 |
| EXP Pharmaceutical Services Corp | 0 | 1 |
| In2Bones, SAS | 0 | 1 |
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Jul 6, 1998 | K974025 | ANSPACH SHIELDED ATTACHMENT The Anspach Effort, Inc. | GFF |
| Mar 1, 1995 | K950449 | SURGICAL BUR Transidyne General Corp. | GFF |
| Aug 22, 1994 | K943758 | SURGICAL BUR Komet Medical | GFF |
| Jan 26, 1994 | K934583 | BURRS American Medical Specialties, Inc. | GFF |
| Aug 21, 1989 | K894438 | MICRO-AIRE CUTTERS FOR MIDAS-REX INSTRUMENTS Micro-Aire Surgical Instruments, Inc. | GFF |
| Jan 24, 1989 | K890090 | DANEK IRRIGATING BURR (DIB) SET Danek Medical, Inc. | GFF |
| Sep 15, 1988 | K883255 | KOMET SURGICAL BUR Komet Medical, Div. of Brasseler USA I, L.P. | GFF |
| Mar 21, 1988 | K880859 | SURGICAL BURS New England Surgical Instrument Corp. | GFF |
| Feb 26, 1988 | K880706 | SURGICAL BURS Nuell Air Equipment & Hospital Supplies, Inc. | GFF |
| Jul 2, 1987 | K872475 | SURGICAL BUR Tava Surgical Instruments | GFF |
| Aug 11, 1986 | K862852 | MICRO-AIRE REPLACE OTOLOGY BURS/ZIM HALL SUR INSTR Micro-Aire Surgical Instruments, Inc. | GFF |
| Sep 24, 1985 | K853658 | BURS FOR MICRO SURGICAL DRILL SYSTEM Acumed Instruments Corp. | GFF |
| Mar 1, 1985 | K850497 | MICRO-AIRE GENERIC BURS & DRILLS Micro-Aire Surgical Instruments, Inc. | GFF |
| Apr 25, 1984 | K841298 | HOLE CHAMFERING DEVICE Techmedica, Inc. | GFF |
| Jun 10, 1982 | K821485 | DERMABRADERS Spire Medical, Inc. | GFF |
| Feb 23, 1982 | K820281 | MICRO-AIRE REPLACEMENT DRILL BURS Micro-Aire Surgical Instruments, Inc. | GFF |
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