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TRAUS SUS10

Saeshin Precision Co., Ltd. · Model TRAUS MBP10SX · UDI-DI 08809260470033

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

Description

127.6(L) x 25.7(D)

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.