FHF
3 FDA 510(k) clearances · Product code
FDA profile
- Official device name
- System, Evacuator, Fluid
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 876.4370
- Medical specialty
- Gastroenterology, Urology
- Adverse events (MAUDE)
- 1992: 4 · 1993: 1 · 1995: 1 · 1999: 2 · 2015: 15
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 |
|---|---|---|
| DISPOSABLE SUCTION AND IRRIGATION SYSTEM (K093479) | Modern Medical Equipment Mfg., Ltd. | 2010-05-19 |
| SUCTION IRRIGATOR (K003443) | Applied Medical | 2001-02-01 |
| CATHETER, MEDIASTINAL&PERICARDIAL (K771986) | The Minnesota Back Brace Co. | 1977-10-28 |
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Every clearance here is in the API, with alerts when new ones post.