IWQ
3 FDA 510(k) clearances · Product code
FDA profile
- Official device name
- Curtain, Protective, Radiographic
- Device class
- Class I (low risk)
- Regulation
- 21 CFR 892.6500
- Medical specialty
- Radiology
- Adverse events (MAUDE)
- 1994: 1 · 1996: 2 · 1997: 5 · 2000: 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 |
|---|---|---|
| MAVIG LOWER BODY PROTECTION SYSTEMS, ASSEMBLY MODELS 6265, 6266, 6267, 6268, 6269/0, 629/1, AND 6269/2 (K945238) | F. Walter Hanel GmbH | 1994-12-15 |
| X-RAY DRAPES (K923099) | Hydro-Med Products, Inc. | 1992-10-15 |
| TECHTON PROTECTIVE PAD (K873038) | Techton, Inc. | 1989-04-03 |
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Every clearance here is in the API, with alerts when new ones post.