MTZ
2 FDA 510(k) clearances · Product code
FDA profile
- Official device name
- Wrap, Implant, Orbital
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 886.3320
- Medical specialty
- Ophthalmic
- Flags
- Implant
- Adverse events (MAUDE)
- 1999: 13 · 2000: 3 · 2003: 28
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 |
|---|---|---|
| MACROPORE SURGICAL BARRIER FILM (K023643) | Macropore Biosurgery, Inc. | 2003-02-21 |
| OCU-GUARD ORBITAL IMPLANT WRAP, SUPPLE OCU-GUARD ORBITAL IMPLANT WRAP (K973552) | Bio-Vascular, Inc. | 1997-12-16 |
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Every clearance here is in the API, with alerts when new ones post.