EME
3 FDA 510(k) clearances · Product code
FDA profile
- Official device name
- Punch, Biopsy, Surgical
- Device class
- Class I (low risk)
- Regulation
- 21 CFR 872.4565
- Medical specialty
- Dental
- Adverse events (MAUDE)
- 2001: 1 · 2003: 2
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 |
|---|---|---|
| BIOPSY PUNCH, SURGICAL (K933670) | Byron Medical | 1994-01-07 |
| PULPDENT POLYAMIDE DENTIN LINER (K911285) | Pulpdent Corp. | 1991-10-09 |
| EURO-MED LIGHT TOUCH BIOPSY PUNCH (K884740) | Buckman Co., Inc. | 1989-03-06 |
Track EME automatically
Every clearance here is in the API, with alerts when new ones post.