HDL
2 FDA 510(k) clearances · Product code
FDA profile
- Official device name
- Retractor, Vaginal
- Device class
- Class I (low risk)
- Regulation
- 21 CFR 884.4520
- Medical specialty
- Obstetrics/Gynecology
- Adverse events (MAUDE)
- 1999: 2 · 2003: 1 · 2007: 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 |
|---|---|---|
| VAGINAL RETRACTORS - KRISTELLER, DELEE, BREISKY (K891038) | Zinnanti Surgical Instruments, Inc. | 1989-03-17 |
| VAGINAL RETRACTOR (K780349) | Edward Weck, Inc. | 1978-03-14 |
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Every clearance here is in the API, with alerts when new ones post.