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ROLLO 57X10X8E/*K110*/FUTREX

AB MEDICA GROUP, S.A. · Model 1005703 · UDI-DI 08428763003267

DSF
10
510(k) clearances
6
Adverse events
1
Recalls
51
Facilities

Recalls

DateFirmReason
2015-12-02Gsi Group IncThe item was recalled due to an increased user/patient risk of exposure to fire and/or electrical shock due to the failure of the PRN 50-M+ Digital Writer

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Linked GUDID · 510(k)/PMA · MAUDE · recalls · establishments. Free tier, no card required.

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Data 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.