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AXIOM®

ETABLISSEMENTS ANTHOGYR · Model 10476D · UDI-DI 03663394170147

EBW Prescription
10
510(k) clearances
392
Adverse events
2
Recalls
69
Facilities

Description

10 SINGLE-USE SPRAY ATT.

Recalls

DateFirmReason
2017-12-21W & H DentalWerk Burmoos GMBH - Site 1During continuous postmarket surveillance activities, we have noticed a potential malfunction of individual foot controls of the type S-N1/S-N2. In case the error occurs, the foot
2013-10-24Nobel Biocare Usa LlcThe recall was initiated because there is a potential for malfunction of the OsseoCare Pro when used with the OseeoCare Pro iPad application software release 1.2.0.7.

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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.