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Needle, Tumor Localization
FDA product code MIJ · Class 1 · General, Plastic Surgery
119
Registered devices
119
Adverse events
3
Recalls
0
510(k) clearances
Devices with this code
Duo System Stereo — SOMATEX Medical Technologies GmbHCook — COOK INCORPORATEDKopans — COOK INCORPORATEDKopans — COOK INCORPORATEDMEDWIRE — MEDAX SRL UNIPERSONALEMRI Tuloc — SOMATEX Medical Technologies GmbHCook — COOK INCORPORATEDTuloc Premium — SOMATEX Medical Technologies GmbHKopans — COOK INCORPORATEDDXRBL-19.5-5.0-S — Izi Medical Products, LLCKopans — COOK INCORPORATEDKopans — COOK INCORPORATEDMEDWIRE — MEDAX SRL UNIPERSONALESINUREP — MEDAX SRL UNIPERSONALEDKBL-20-5.0-A-U — Izi Medical Products, LLCMEDWIRE — MEDAX SRL UNIPERSONALEMEDWIRE — MEDAX SRL UNIPERSONALEMEDWIRE — MEDAX SRL UNIPERSONALEKopans — COOK INCORPORATEDMEDWIRE — MEDAX SRL UNIPERSONALEDKBL-21-5.0-A-U — Izi Medical Products, LLCDKBL-20-7.0-A-U — Izi Medical Products, LLCDKBL-21-15.0-A — Izi Medical Products, LLCALM SET — H.S. HOSPITAL SERVICE SPA
Recent recalls
| Date | Firm | Reason |
|---|---|---|
| 2021-02-03 | Somatex Medical Technologies GMBH | This recall has been initiated due to the risk of wire splintering after contact with a cautery device during the removal of a lesion. There is a potential risk |
| 2016-01-08 | Cook Inc. | Product potentially exposed to body fluids during processing. Potential adverse events that may occur as a result of the foreign matter include blood borne pat |
| 2003-09-04 | Alpha-Omega Services Inc | Template needle may fracture leaving tip in patient. |
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