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BIONEN
BIONEN SAS DI BARBARA NENCIONI & C. · Model 0028012 · UDI-DI 08033315122299
IKT
Prescription
1
510(k) clearances
150
Adverse events
2
Recalls
39
Facilities
Description
Concentric Needle Electrode for EMG
Recalls
| Date | Firm | Reason |
|---|---|---|
| 2022-08-09 | Technomed Europe | Burns of varying degrees can occur to patients with electrodes left in while in the MRI scanner as a result of inadequate safety information in the IFU. |
| 2007-04-12 | Chalgren Enterprises Inc | Sterility Compromised-- Investigation found that individual packaging seals were separating, which may compromise sterility. |
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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.