HAD
3 FDA 510(k) clearances · Product code
FDA profile
- Official device name
- Rongeur, Powered
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 882.4845
- Medical specialty
- Neurology
- Flags
- Third-party review eligible
- Adverse events (MAUDE)
- 1995: 1 · 2000: 2 · 2015: 15 · 2016: 10
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 |
|---|---|---|
| AESCULAP PNEUMATIC KERRISON (K062413) | Aesculap, Inc. | 2006-11-21 |
| ANSPACH POWERED KERRISON SYSTEM (PKS) (K022907) | The Anspach Effort, Inc. | 2002-10-21 |
| STAYFREE, UNSCENTED/SCENTED/SCENTED DEODOR MEN PAD (K911637) | Personal Products Co. | 1991-08-02 |
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Every clearance here is in the API, with alerts when new ones post.