BEUDAMED
    7 results · 29ms · Sources: EU EUDAMED, US FDA

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    THE BI-DIRECTIONAL SPIRAL & EPOXY ROOT CANAL CEMENT SYSTEM

    FDA 510(k)
    FDA Class 2 ·Dental

    K-ASSAY (R) RF (Ver.2), K-ASSAY (R) RF Calibrator (Ver.2)

    FDA 510(k)
    FDA Class 2 ·Immunology

    H100B PULSE OXIMETER

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    RESTORE ULTRA

    FDA Adverse Event
    Injury ·MEDTRONIC MED REL MEDTRONIC PUERTO RICO·Product code LGW·August 11, 2015

    EXTENDED BRILLIANCE WORKSTATION (EBW)

    FDA Adverse Event
    Other ·PHILIPS MEDICAL SYSTEMS (CLEVELAND), INC.·Product code JAK·March 1, 2013

    EVERA XT DR

    FDA Adverse Event
    Malfunction ·MEDTRONIC PUERTO RICO OPERATIONS CO.·Product code LWS·August 8, 2014

    GXL acetabular liners, orthopedic hip implant component. Product Line Numbers: a. NOVATION CONSTRAINED LINER 28MM ID GROUP 1, REF 134-28-41 b. NOVATION CONSTRAINED LINER 32MM ID GROUP 2, REF 134-32-42 c. NOVATION CONSTRAINED LINER 36MM ID GROUP 3, REF 134-36-43 d. NOVATION CONSTRAINED LINER 36MM ID GROUP 4, REF 134-36-44 e. NOVATION CONSTRAINED LINER 36MM ID GROUP 5, REF 134-36-45

    FDA Enforcement
    Class II ·Ongoing·Exactech, Inc.·September 21, 2022