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 |
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Nov 2, 1984 | K843784 | VITAJET JET INSULIN INJECTION DEVICE Vitajet Industriae Comercioltda., BR | KZE |
| Mar 6, 1984 | K834044 | MEDI-JECTOR II Derata Corp. | KZE |
| Dec 8, 1977 | K772129 | MEDI-JECTOR Derata Corp. | KZE |
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