Panels › General, Plastic Surgery › Product code MIJ · Class 1
Needle, Tumor Localization
Regulation 878.4800
0510(k)s in 12 months (0 all time)
0recalls in 12 months (3 all time)
0recalls that name a 510(k)
Top companies in MIJ
| Company | 510(k)s | Recalls |
|---|---|---|
| Alpha-Omega Services Inc | 0 | 1 |
| Cook Inc. | 0 | 1 |
| Somatex Medical Technologies GMBH | 0 | 1 |
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Feb 3, 2021 | Somatex Medical Technologies GMBH Thread-like wire marker Terminated |
MIJ | None listed |
| Feb 29, 2016 | Cook Inc. Kopans Breast Lesion Localization Needle
The Kopans Breast Lesion Localization Needle consists of a bevel-tip needle with centimeter markings and a hookwire. The hookwire features a burnish mark that Terminated |
MIJ | None listed |
| Jul 20, 2004 | Alpha-Omega Services Inc Template Needle, Series 17, 20 cm, with Threaded Female hub and Bent Stylet, Closed-End, Disposable.
Packaged in single, 10, 15, 20 per package. Terminated |
MIJ | None listed |
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