BEUDAMED
    8 results · 27ms · Sources: EU EUDAMED, US FDA

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    TB METHYLENE BLUE

    FDA 510(k)
    FDA Class 1 ·Hematology

    Patterson

    FDA UDI
    PATTERSON DENTAL SUPPLY, INC.·D6620708721841·FILE, PULP CANAL, ENDODONTIC

    X-RAY SYSTEM FOR DENTAL APPLICATION

    FDA 510(k)
    FDA Class 2 ·Dental

    VITOSS BIOACTIVE FOAM BONE GRAFT SUBSTITUTE

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    SHIP KIT, PROCEDURE KIT, PROTEKDUO LS - DL31 for temporary Cardiopulmonary bypass. Including the following components: a) 31 Fr ProtekDuo Veno-Venous Cannula Set b) LifeSPARC Pump c) 14Fr to 26 Fr Dilator Set d) TandemHeart Wrap. Kit Number: 5820-3118 Intended use is applicable to the intended use of specific devices included in the kit.

    FDA Enforcement
    Class III ·Ongoing·Cardiac Assist, Inc·December 8, 2021

    PORTABLE OXYGEN GENERATOR (CONCENTRATOR, HOMEFILL)

    FDA Adverse Event
    Malfunction ·INVACARE FLORIDA OPERATIONS·Product code CAW·June 13, 2014

    GYNECARE MORCELLEX TISSUE MORCELLATOR

    FDA Adverse Event
    Malfunction ·ETHICON, INC.·Product code HET·October 12, 2010

    HOMECHOICE PRO

    FDA Adverse Event
    Malfunction ·BAXTER HEALTHCARE - LARGO·Product code FKX·December 13, 2012