BEUDAMED
    8 results · 28ms · Sources: EU EUDAMED, US FDA

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    Arthrex UNIVERS REVERS COATED BASEPLATE

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    ODYSSEY WORKSTATION

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    LOGIQ P3

    FDA 510(k)
    FDA Class 2 ·Radiology

    PROMOTE ACCEL, CRT-D

    FDA Adverse Event
    Malfunction ·ST. JUDE MEDICAL, INC.·Product code NIK·January 13, 2014

    SIG MOD TIB TRAY CEM COCR 3

    FDA Adverse Event
    Injury ·1219655 DEPUY-RAYNHAM, A DIV. OF DEPUY ORTHOPAEDIC·Product code JWH·June 17, 2013

    ACCU-CHEK SPIRIT

    FDA Adverse Event
    Malfunction ·ROCHE INSULIN DELIVERY SYSTEMS INC.·Product code LZG·June 17, 2011

    Allura Xper FD20 Product Codes: (1)722012, (2) 722028, (3) 722006; Associated 510(k) numbers: K102005, K130842, K130638, K133292, K141979, K161563, K162859, K033737, K041949;

    FDA Enforcement
    Class II ·Ongoing·PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.·October 1, 2025

    Allura Xper FD20; Catalog numbers: (1) 722006, (2) 722012, (3) 722028.

    FDA Enforcement
    Class I ·Ongoing·PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.·February 26, 2025