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XAVANT TECHNOLOGY (PTY) LTD · Model STIMPOD NMS415 KIT · UDI-DI 06009880396023
BXN
Prescription
1
510(k) clearances
31
Adverse events
5
Recalls
19
Facilities
Description
The STIMPOD NMS415 is a precision nerve mapping tool used for localizing specific neural pathways. Localization of nerves by electrical stimulation involves connecting the nerve stimulator to the nerve mapping probe. The distance of the nerve mapping probe from the nerve can be estimated by establishing the minimum threshold current required, to facilitate a neuromuscular response.
Recalls
| Date | Firm | Reason |
|---|---|---|
| 2024-05-17 | B Braun Medical Inc | The devices are labeled "not made with DEHP" or the DEHP free symbol; however, the glue used contains traces of DEHP. |
| 2024-05-17 | B Braun Medical Inc | The devices are labeled "not made with DEHP" or the DEHP free symbol; however, the glue used contains traces of DEHP. |
| 2024-05-17 | B Braun Medical Inc | The devices are labeled "not made with DEHP" or the DEHP free symbol; however, the glue used contains traces of DEHP. |
| 2024-05-17 | B Braun Medical Inc | The devices are labeled "not made with DEHP" or the DEHP free symbol; however, the glue used contains traces of DEHP. |
| 2010-02-01 | Stryker Instruments Div. of Stryker Corporation | Device may malfunction and lead to ineffective stimulation, which could delay finding the nerve and the effects of the nerve block. |
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Get your free API keyRead the docsData compiled from public U.S. FDA sources (GUDID, 510(k)/PMA, MAUDE, recalls, establishment registration). Adverse-event reports are unverified and do not establish causation. Informational only — not medical, clinical, or regulatory advice.
