Panels › General, Plastic Surgery › Product code GFA · Class 1
Blade, Saw, General & Plastic Surgery, Surgical
Regulation 878.4820
0510(k)s in 12 months (27 all time)
0recalls in 12 months (19 all time)
2recalls that name a 510(k)
Top companies in GFA
| Company | 510(k)s | Recalls |
|---|---|---|
| Biomet, Inc. | 0 | 4 |
| Micro-Aire Surgical Instruments, Inc. | 4 | 0 |
| Synvasive Technology Inc | 0 | 3 |
| Terumo Cardiovascular Systems Corporation | 0 | 3 |
| Boehringer Laboratories | 2 | 0 |
| Linvatec Corp. dba ConMed Linvatec | 0 | 2 |
| Omega Surgical Instruments, Inc. | 2 | 0 |
| Wrightmedicaltechnologyinc | 2 | 0 |
| 3M Health Care, Sarns | 1 | 0 |
| Adven Medical | 1 | 0 |
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Jun 18, 1997 | K971978 | GRAFT HARVESTING SAWBLADES Wrightmedicaltechnologyinc | GFA |
| Jan 30, 1996 | K954483 | STRYKER SAGITTAL SAW ATTACHMENT Stryker Instruments | GFA |
| Jan 18, 1996 | K955229 | WRIGHT MEDICAL TECHNOLOGY SAWBLADES Wrightmedicaltechnologyinc | GFA |
| Jul 12, 1995 | K953012 | DISPOSABLE & REUSABLE SURGICAL CUTTING TOOLS Boston Surgical Products, Inc. | GFA |
| Feb 21, 1995 | K950403 | SURGICAL SAW BLADES Transidyne General Corp. | GFA |
| Jun 28, 1994 | K940501 | RE-SHARPENABLE SAW BLADES Adven Medical | GFA |
| Mar 16, 1994 | K933595 | BUR, SURGICAL, GENERAL & PLASTIC SURGERY Omega Surgical Instruments, Inc. | GFA |
| Feb 24, 1994 | K935391 | SARNS STERNAL SAW II, STERNAL SAW II BLADE, SARNS SAW BLADES-NON-STERILE BULK PACK 3M Health Care, Sarns | GFA |
| Feb 22, 1994 | K934603 | SURGICAL SAW BLADES American Medical Specialties, Inc. | GFA |
| Jan 27, 1994 | K931769 | SNAP OSCILLATING SAW Surgiquip, Inc. | GFA |
| Jan 26, 1994 | K934390 | OSCILLATING BONE SAW BLADE, 6200 SERIES Boehringer Laboratories | GFA |
| Nov 18, 1993 | K931210 | INTERMEDICS ORTHOPEDICS SAW BLADE Intermedics Orthopedics | GFA |
| Aug 9, 1993 | K933298 | SAW BLADE Omega Surgical Instruments, Inc. | GFA |
| Jan 21, 1993 | K924953 | FLUID COOLED BONE SAW BLADE, 6000 SERIES Boehringer Laboratories | GFA |
| Jul 19, 1991 | K912761 | SURGICAL SAW BLADES Blairden Precision Instruments, Inc. | GFA |
| Nov 22, 1989 | K896280 | MICRO-AIRE OSCILLATING SAW BLADE 202C-25, 202C-50 Micro-Aire Surgical Instruments, Inc. | GFA |
| Oct 14, 1986 | K863788 | SAWBLADE Tava Surgical Instruments | GFA |
| May 30, 1986 | K861876 | CRANIO BLADES AND WIRE PASS DRILL New England Surgical Instrument Corp. | GFA |
| Nov 13, 1985 | K854192 | ANADIAS NASAL SAW BLADES Anadias, Inc. | GFA |
| May 21, 1985 | K851880 | BRIMFIELD SCIEN. INSTRU. DISPOS. STERILE SURG. BLA J-Pac, LLC | GFA |
| Jul 7, 1983 | K831714 | MICRO-AIRE REPLACEMENT SURG. SAW BLADE Micro-Aire Surgical Instruments, Inc. | GFA |
| Apr 12, 1983 | K830434 | DISPOSABLE INTRA-ARTICULAR BLADE Concept, Inc. | GFA |
| Jul 2, 1982 | K821487 | MICRO-SURGICAL POWER INSTRUMENT SYS. Spire Medical, Inc. | GFA |
| Mar 23, 1982 | K820601 | REPLACEMENT SAW BLADES FOR STRYKER AIR Micro-Aire Surgical Instruments, Inc. | GFA |
| Aug 13, 1981 | K811506 | MICRO-AIRE REPLACEMENT SAW BLADES Micro-Aire Surgical Instruments, Inc. | GFA |
| Feb 12, 1981 | K810045 | I.M. RETROGRADE BLADES Hogan & Hartson | GFA |
| Dec 11, 1980 | K802838 | STERNUM SAW BLADE Amsco Co. | GFA |
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