HWN
4 FDA 510(k) clearances · Product code
FDA profile
- Official device name
- Instrument, Compression
- Device class
- Class I (low risk)
- Regulation
- 21 CFR 888.4540
- Medical specialty
- Orthopedic
- Adverse events (MAUDE)
- 2021: 88 · 2022: 64 · 2023: 82 · 2024: 83 · 2025: 181 · 2026: 83
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 |
|---|---|---|
| AOT EXTERNAL COMPRESS DEVICE (K854241) | Advanced Ortho-Technology, Inc. | 1986-03-03 |
| ARICULATED TENSION DEVICE SYNTHES TEN (K792253) | Synthes (Usa) | 1979-12-05 |
| RIGID TEACHING ATTACHMENT (K770349) | Richard Wolf Medical Instruments Corp. | 1977-03-07 |
| FLORIO CPC BAND (K760970) | Richard'S Medical Equip., Inc. | 1976-11-23 |
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Every clearance here is in the API, with alerts when new ones post.