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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
SINUREP — MEDAX SRL UNIPERSONALEMEDWIRE — MEDAX SRL UNIPERSONALEMEDWIRE — MEDAX SRL UNIPERSONALEKopans — COOK INCORPORATEDMRI Tuloc — SOMATEX Medical Technologies GmbHSINUREP — MEDAX SRL UNIPERSONALEALM SET — H.S. HOSPITAL SERVICE SPAKopans — COOK INCORPORATEDTuflex Premium — SOMATEX Medical Technologies GmbHMEDWIRE — MEDAX SRL UNIPERSONALEMEDWIRE — MEDAX SRL UNIPERSONALEDXRBL-18-5.0 — Izi Medical Products, LLCKopans — COOK INCORPORATEDNuaskin Skin Tag Remover — HOME AIDE DIAGNOSTICS, INC.DGC-30-5 — Izi Medical Products, LLCKopans — COOK INCORPORATEDMEDWIRE — MEDAX SRL UNIPERSONALEDKBL-21-5.0-A — Izi Medical Products, LLCTuloc — SOMATEX Medical Technologies GmbHALM SET — H.S. HOSPITAL SERVICE SPATuflex — SOMATEX Medical Technologies GmbHKopans — COOK INCORPORATEDMEDWIRE — MEDAX SRL UNIPERSONALEKopans — COOK INCORPORATED
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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