HWJ
4 FDA 510(k) clearances · Product code
FDA profile
- Official device name
- Awl
- Device class
- Class I (low risk)
- Regulation
- 21 CFR 888.4540
- Medical specialty
- Orthopedic
- Adverse events (MAUDE)
- 2016: 24 · 2017: 12 · 2018: 11 · 2019: 17 · 2024: 17 · 2026: 18
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 |
|---|---|---|
| CROSS MEDICAL PRODUCT PEDICLE AWL (K895587) | Cross Medical Products, Inc. | 1990-01-04 |
| ACROMED AWL/PUNCH, DEPTH GAUGE (K880045) | Buckman Co., Inc. | 1988-02-17 |
| DANNINGER ORTHOPAEDIC AWL (K875223) | Danninger Medical Technology, Inc. | 1988-02-17 |
| ACROMED WALLIE-HEINIG TROCHAR (K870779) | Buckman Co., Inc. | 1987-03-09 |
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Every clearance here is in the API, with alerts when new ones post.