BEUDAMED
    11 results · 22ms · Sources: EU EUDAMED, US FDA

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    DISPOSABLE STOPCOCK

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    Ovation® C

    FDA UDI
    DENTSPLY SIRONA ORTHODONTICS INC.·D807K310532111·OVATION® C RT RX 022 U5-5/L3-3 CS BC HK

    Ovation® C EURO

    FDA UDI
    DENTSPLY SIRONA ORTHODONTICS INC.·D807K310532801·OVATION® C EURO 022 U5-5/L3-3 CS HK

    Ovation® C

    FDA UDI
    DENTSPLY SIRONA ORTHODONTICS INC.·D807K310532101·OVATION® C Base Rx 022 U5-5/L3-3 CS HK

    MYSTIQUE® MB

    FDA UDI
    DENTSPLY SIRONA ORTHODONTICS INC.·D807K110532101·MYSTIQUE® MB RT RX 022 U 5-5/L3-3 CS HK

    S.K. DIAG. ULTRASOUND BODY SCANNER

    FDA 510(k)
    FDA Class 2 ·Radiology

    OSTEOSET BVF KIT

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    VIRTUOSO DR

    FDA Adverse Event
    Injury ·MEDTRONIC S.A.·Product code LWS·October 31, 2012

    SUPRAMID BLACK 3/0 (2) 45CM HS15

    FDA Adverse Event
    Malfunction ·B.BRAUN SURGICAL S.A.·Product code FTL·April 16, 2014

    SPECTRUM INFUSION PUMP

    FDA Adverse Event
    Malfunction ·BAXTER HEALTHCARE CORPORATION·Product code FRN·May 29, 2015

    OPTETRAK Comprehensive Knee System including OPTETRAK Logic RBK PS Tibial Components (Product Line: 02-012-38-XXXX). NOTE: Information reflects Exactech recall expansion initiated on 02/07/2022.

    FDA Enforcement
    Class II ·Ongoing·Exactech, Inc.·October 13, 2021