HMW
4 FDA 510(k) clearances · Product code
FDA profile
- Official device name
- Drape, Microscope, Ophthalmic
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 878.4370
- Medical specialty
- General, Plastic Surgery
- Adverse events (MAUDE)
- 1994: 1 · 2006: 6
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 |
|---|---|---|
| INVOTEC MICROSCOPE DRAPE (K911040) | Invotec International, Inc. | 1991-06-03 |
| STERILE INSTRUMENT DRAPE (K902763) | North American Sterilization & Packaging Co. | 1990-09-20 |
| MICROSCOPE DRAPE (K902851) | Medical Technique Instruments, Inc. | 1990-09-10 |
| CUSTOM INSTRUMENT DRAPE (K843890) | Lifestream Int'L, Inc. | 1984-10-26 |
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Every clearance here is in the API, with alerts when new ones post.