BEUDAMED
    7 results · 19ms · Sources: EU EUDAMED, US FDA

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    SPOTFIRE RSP Pos & Neg Controls (M425), SPOTFIRE RSP Positive Control (M42638), SPOTFIRE RSP Negative Control (M42738)

    FDA 510(k)
    FDA Class 2 ·Microbiology

    Fenom Pro

    FDA 510(k)
    FDA Class 2 ·Clinical Toxicology

    CALCIGEN -NAP BONE VOID FILLER

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    OT ULTRALINK METER

    FDA Adverse Event
    Malfunction ·LIFESCAN INC.·Product code NBW·September 2, 2011

    PFC SIGMA C/S NPOR FEM LT SZ 5

    FDA Adverse Event
    Injury ·DEPUY-RAYNHAM, A DIV OF DEPUY ORTHOPAEDICS, INC.·Product code JWH·November 14, 2008

    GYNECARE TVT EXACT CONTINENCE SYSTEM

    FDA Adverse Event
    Injury ·ETHICON INC.·Product code OTN·July 18, 2013

    Azurion 5 M20; System Code: (1)722228, (2)722232, (3) 722281 (OUS only);

    FDA Enforcement
    Class II ·Ongoing·PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.·April 8, 2026