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

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    DIRECT WRITING VECTORCARDIOGRAPH

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    NA

    FDA UDI
    LANCER ORTHODONTICS, INC.·00817573023073·ETCH-FORMULA SERIES GEL 24g 1/PK

    NA

    FDA UDI
    Zimmer, Inc.·00889024274020·

    Coonrad/Morrey Total Elbow

    FDA UDI
    Zimmer, Inc.·00889024701922·

    NA

    FDA UDI
    Zimmer, Inc.·00889024639775·

    ENDOFLIP GASTRIC TUBE

    FDA 510(k)
    FDA Class 2 ·Gastroenterology, Urology

    TITANIUM CEMENT RESTRICTOR MATERIAL PLDLA

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    SPECTRUM INFUSION PUMP

    FDA Adverse Event
    Malfunction ·BAXTER HEALTHCARE CORPORATION·Product code FRN·January 9, 2014

    CAPSURE SP

    FDA Adverse Event
    Injury ·MEDTRONIC PUERTO RICO, INC.·Product code DTB·October 31, 2012

    ACCESS® 2 IMMUNOASSAY SYSTEM

    FDA Adverse Event
    Malfunction ·BECKMAN COULTER INC.·Product code MMI·August 20, 2010

    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