MLZ
4 FDA 510(k) clearances · Product code
FDA profile
- Official device name
- Vitrectomy, Instrument Cutter
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 886.4150
- Medical specialty
- Ophthalmic
- Flags
- Third-party review eligible
- Adverse events (MAUDE)
- 2021: 40 · 2022: 40 · 2023: 92 · 2024: 188 · 2025: 256 · 2026: 85
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 |
|---|---|---|
| Vista Ophthalmics Vitrectomy Probe (K220030) | Vista Ophthalmics, LLC | 2022-05-04 |
| HyperVit Vitrectomy Probe, 23 GA, HyperVit Vitrectomy Probe, 25+, HyperVit Vitrectomy Probe, 27+ (K170520) | Alcon Research, Ltd. | 2017-03-22 |
| ENHANCED ULTRA VIT PROBE (K093305) | Alcon Research, Ltd. | 2010-04-02 |
| VITRECTOMY CUTTER AND ACCESSORIES (K081681) | Advanced Medical Optics, Inc. | 2008-10-08 |
Track MLZ automatically
Every clearance here is in the API, with alerts when new ones post.