GFD
12 FDA 510(k) clearances · Product code
41 daysmedian time to decision
115 days90th percentile
12clearances measured
FDA profile
- Official device name
- Dermatome
- Device class
- Class I (low risk)
- Regulation
- 21 CFR 878.4820
- Medical specialty
- General, Plastic Surgery
- Adverse events (MAUDE)
- 2021: 614 · 2022: 545 · 2023: 806 · 2024: 796 · 2025: 760 · 2026: 416
Reports received by FDA, not confirmed device causation - volume tracks device popularity as much as risk.
Export predicate table (CSV) Shareable report ◉ Watch exports: 3 free/month · reports & watching: free
| Record | Firm | Date |
|---|---|---|
| DMS-1000C DERMOABRADER (K965256) | Mattioli Engineering, Srl | 1996-12-09 |
| DERMTOME BLADE (K962371) | Dsp Worldwide | 1996-08-29 |
| DECA DERMATOME (MICROMOTOR SYSTEM) (K945594) | Depuy Intl., Ltd. | 1995-06-05 |
| PADGETT AIR DERMATOME, MODEL A (K951085) | Padgett Instruments, Inc. | 1995-05-15 |
| AESCULAP ACCU-DERMATOME (K940208) | Aesculap, Inc. | 1994-02-24 |
| ACTIVATED PARTIAL THROMBOPLASTIN TIME TEST (K862669) | U. S. Diagnostics, Inc. | 1986-10-03 |
| SKIN MESH DEVICE (K861285) | Precision Modified Devices | 1986-04-17 |
| MASH DERMATOME (K861138) | Mecron Medical Products, Inc. | 1986-04-14 |
| DERMASPANDERE (K860925) | Mri Ventures, Inc. | 1986-03-28 |
| ROSENBERG SKIN GRAFTING KNIVES (K842702) | Downs Surgical , Ltd. | 1984-08-02 |
| AMPLIGREFFE (K830993) | Prothia USA, Inc. | 1983-05-03 |
| DAVOL/SIMON DERMATOME (K792332) | Davol, Inc. | 1979-12-06 |
Track GFD automatically
Every clearance here is in the API, with alerts when new ones post.