EZR
6 FDA 510(k) clearances · Product code
50 daysmedian time to decision
71 days90th percentile
6clearances measured
FDA profile
- Official device name
- Cement, Stomal Appliance, Ostomy
- Device class
- Class I (low risk)
- Regulation
- 21 CFR 876.5900
- Medical specialty
- Gastroenterology, Urology
- Adverse events (MAUDE)
- 1994: 1 · 1995: 1 · 1997: 1 · 2004: 1 · 2005: 2 · 2006: 3
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 |
|---|---|---|
| UNITED SKIN BARRIER PASTE (K844341) | Howmedica Corp. | 1985-01-18 |
| STOMAHESIVE PASTE PROTECTIVE SKIN BARR (K803100) | E. R. Squibb & Sons, Inc. | 1981-01-08 |
| COLO-TAPE (K791146) | Suburban Ostomy Supply Co., Inc. | 1979-07-30 |
| OSTOMY KARAYA GUM POWDER (K761340) | Howmedica Corp. | 1977-03-07 |
| KARAYA GUM POWDER (K770230) | Atlantic Surgical | 1977-02-28 |
| KARAYA GUM PRODUCTS - PROCESS CHANGE (K761319) | Howmedica Corp. | 1977-02-15 |
Track EZR automatically
Every clearance here is in the API, with alerts when new ones post.