KTA
8 FDA 510(k) clearances · Product code
45 daysmedian time to decision
91 days90th percentile
8clearances measured
FDA profile
- Official device name
- Medium, Contrast, Radiologic
- Device class
- Unclassified
- Medical specialty
- Unknown
- Adverse events (MAUDE)
- 1992: 1 · 1994: 1 · 1996: 7 · 1998: 1 · 2005: 2 · 2007: 7
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 |
|---|---|---|
| MEDEFIZZ A & MEDEFIZZ B (K800843) | Medefield Pty. , Ltd. | 1980-06-17 |
| MEDEFOAM-2 (K800840) | Medefield Pty. , Ltd. | 1980-06-17 |
| BARIUM SULFATE, USP IN SUSPENSION (K800459) | Central Pharmaceuticals, Inc. | 1980-05-30 |
| MEDEBAR M (K800841) | Medefield Pty. , Ltd. | 1980-05-30 |
| MEDEBAR XAC-90 (K800842) | Medefield Pty. , Ltd. | 1980-05-30 |
| MEDESCAN (K800839) | Medefield Pty. , Ltd. | 1980-05-30 |
| MEDEBAR XL (K800844) | Medefield Pty. , Ltd. | 1980-05-30 |
| BARIMEX, BARIUM SULFATE COMPOUND (K760736) | C.R. Bard, Inc. | 1976-11-09 |
Track KTA automatically
Every clearance here is in the API, with alerts when new ones post.