Panels › General, Plastic Surgery › Product code GFD · Class 1
Dermatome
Regulation 878.4820
0510(k)s in 12 months (12 all time)
2recalls in 12 months (22 all time)
0recalls that name a 510(k)
Top companies in GFD
| Company | 510(k)s | Recalls |
|---|---|---|
| Zimmer Surgical Inc | 0 | 15 |
| Integra LifeSciences Corp. | 0 | 4 |
| KCI USA, INC. | 0 | 2 |
| Aesculap, Inc. | 1 | 0 |
| Davol, Inc. | 1 | 0 |
| Depuy Intl., Ltd. | 1 | 0 |
| Downs Surgical , Ltd. | 1 | 0 |
| Dsp Worldwide | 1 | 0 |
| Exsurco Medical | 0 | 1 |
| Mattioli Engineering, Srl | 1 | 0 |
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Dec 9, 1996 | K965256 | DMS-1000C DERMOABRADER Mattioli Engineering, Srl, IT | GFD |
| Aug 29, 1996 | K962371 | DERMTOME BLADE Dsp Worldwide | GFD |
| Jun 5, 1995 | K945594 | DECA DERMATOME (MICROMOTOR SYSTEM) Depuy Intl., Ltd., GB | GFD |
| May 15, 1995 | K951085 | PADGETT AIR DERMATOME, MODEL A Padgett Instruments, Inc. | GFD |
| Feb 24, 1994 | K940208 | AESCULAP ACCU-DERMATOME Aesculap, Inc. | GFD |
| Oct 3, 1986 | K862669 | ACTIVATED PARTIAL THROMBOPLASTIN TIME TEST U. S. Diagnostics, Inc. | GFD |
| Apr 17, 1986 | K861285 | SKIN MESH DEVICE Precision Modified Devices | GFD |
| Apr 14, 1986 | K861138 | MASH DERMATOME Mecron Medical Products, Inc. | GFD |
| Mar 28, 1986 | K860925 | DERMASPANDERE Mri Ventures, Inc. | GFD |
| Aug 2, 1984 | K842702 | ROSENBERG SKIN GRAFTING KNIVES Downs Surgical , Ltd. | GFD |
| May 3, 1983 | K830993 | AMPLIGREFFE Prothia USA, Inc. | GFD |
| Dec 6, 1979 | K792332 | DAVOL/SIMON DERMATOME Davol, Inc. | GFD |
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