BEUDAMED
    9 results · 21ms · Sources: EU EUDAMED, US FDA

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    NRFit Syringe

    FDA 510(k)
    FDA Class 2 ·General Hospital

    AAXTER A3 POSTERIOR SPINAL SYSTEM

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    CHARLOTTE LISFRANC BONE SCREW, CHARLOTTE LISFRANC PLATE

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    PDS II POLYDIOXANONE SUTURE UNKNOWN PRODUCT

    FDA Adverse Event
    Injury ·ETHICON INC.·Product code NEW·July 9, 2018

    PROLENE POLYPROPYLENE SUTURE UNKNOWN PRODUCT

    FDA Adverse Event
    Injury ·ETHICON INC.·Product code GAW·July 9, 2018

    HEARTMATE II LEFT VENTRICULAR ASSIST DEVICE

    FDA Adverse Event
    Injury ·THORATEC CORP.·Product code DSQ·July 21, 2011

    HOMECHOICE AUTOMATED PD SET WITH CASSETTE

    FDA Adverse Event
    Malfunction ·BAXTER HEALTHCARE - MOUNTAIN HOME·Product code FKX·June 21, 2013

    INTERSTIM

    FDA Adverse Event
    Malfunction ·MEDTRONIC PUERTO RICO OPERATIONS CO.·Product code EZW·September 24, 2008

    Vantage Total Ankle System including a. Vantage Fixed-Bearing Polyethylene Liner Component (Product Line: 350-21-XX, 350-22-XX); b. Vantage Mobile-Bearing Polyethylene Liner Component (Product Line: 350-41-XX, 350-42-XX). NOTE: Information reflects Exactech recall expansion initiated on 02/07/2022.

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