Panels › General Hospital › Product code KZE · Class 2
Injector, Fluid, Non-Electrically Powered
Regulation 880.5430
0510(k)s in 12 months (53 all time)
0recalls in 12 months (1 all time)
1recalls that name a 510(k)
Top companies in KZE
| Company | 510(k)s | Recalls |
|---|---|---|
| Bioject, Inc. | 7 | 0 |
| Derata Corp. | 6 | 0 |
| Equidyne Systems, Inc. | 5 | 0 |
| Medi-Ject Corp. | 3 | 0 |
| Pharmajet, Inc. | 3 | 0 |
| Biovalve Technologies, Inc. | 2 | 0 |
| Felton International, Inc. | 2 | 0 |
| National Medical Products, Inc. | 2 | 0 |
| Vitajet Corp. | 2 | 0 |
| Vitajet Industriae Comercioltda. | 2 | 0 |
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| May 11, 2012 | CaridianBCT, Inc. Trima Accel Automated Blood Collection System, catalog number 917000000, Caridian BCT, Lakewood, CO 80215 USA.
Product Usage:
Automated Blood Collection System for use in humans. Terminated |
KZE | K090003 |
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