Panels › General, Plastic Surgery › Product code GAA · Class 1
Needle, Aspiration And Injection, Disposable
Regulation 878.4800
0510(k)s in 12 months (107 all time)
0recalls in 12 months (37 all time)
5recalls that name a 510(k)
Top companies in GAA
| Company | 510(k)s | Recalls |
|---|---|---|
| A.D.T. Lab Industries | 14 | 0 |
| Vitreq Bv | 0 | 10 |
| Medical Device Technologies, Inc. | 3 | 3 |
| Aomori Olympus Co., Ltd. | 0 | 5 |
| Dlp, Inc. | 5 | 0 |
| National Patent Development Corp. | 4 | 0 |
| R. J. Doyle, Inc. | 4 | 0 |
| Symbiosis Corp. | 4 | 0 |
| Hobbs Medical, Inc. | 1 | 2 |
| INNOVATIVE TOMOGRAPHY PRODUCT GMBH | 0 | 3 |
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Jun 22, 1978 | K780887 | IMPROVED DISPOSABLE HYPODERMIC NEEDLE Pharmaseal Div., Baxter Healthcare Corp. | GAA |
| May 26, 1978 | K780624 | CULDOCENTESIS TRAY Cutter Laboratories, Inc. | GAA |
| Nov 30, 1977 | K771784 | IOPSY TRAY FOR SOFT TISSUE BIOPSY Bd Becton Dickinson Vacutainer Systems Preanalytic | GAA |
| Sep 28, 1977 | K771760 | EXTEMP Pharmaco, Inc. | GAA |
| Sep 28, 1977 | K771759 | EXTEMP-V Pharmaco, Inc. | GAA |
| Nov 1, 1976 | K760775 | TERUMO DISPOSABLE SPINAL NEEDLE Terumo America, Inc. | GAA |
| Aug 9, 1976 | K760022 | NEEDLE, FILTER Jelco Laboratories | GAA |
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