MDZ
2 FDA 510(k) clearances · Product code
FDA profile
- Official device name
- Cleaners, Medical Devices
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 880.6992
- Medical specialty
- General Hospital
- Flags
- Third-party review eligible
- Adverse events (MAUDE)
- 1996: 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 |
|---|---|---|
| DECOMAT A 8666 (K920413) | Getinge International, Inc. | 1994-04-05 |
| DECOMAT 228 (K920406) | Getinge International, Inc. | 1994-04-05 |
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