EZK
3 FDA 510(k) clearances · Product code
FDA profile
- Official device name
- Catheter, Retention Type
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 876.5980
- Medical specialty
- Gastroenterology, Urology
- Flags
- Third-party review eligible
- Adverse events (MAUDE)
- 1992: 1 · 1998: 1 · 2003: 1
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 |
|---|---|---|
| E-Z-EM ENTEROCLYSIS CATHETER SET (K911349) | E-Z-Em, Inc. | 1992-11-16 |
| URINE METER FOLEY TRAY WITH TEMPERATURE SENSOR (K903816) | Respiratory Support Products, Inc. | 1990-10-31 |
| KARAYA GUM POWDER, OSTOMY (K770408) | Howmedica Corp. | 1977-03-15 |
Track EZK automatically
Every clearance here is in the API, with alerts when new ones post.