BEUDAMED
    11 results · 20ms · Sources: EU EUDAMED, US FDA

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    HemoScreen Hematology Analyzer

    FDA 510(k)
    FDA Class 2 ·Hematology

    INJEX 30 NEEDLE FREE INJECTION SYSTEM

    FDA 510(k)
    FDA Class 2 ·General Hospital

    E-Fit Infinity System (EF-2090 Controller and EF-100 Unit)

    FDA 510(k)
    FDA Class 2 ·Physical Medicine

    OT ULTRALINK METER

    FDA Adverse Event
    Malfunction ·LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL·Product code NBW·December 24, 2013

    TIBIAL BASEPLATE AUGMENT MODEL KC-22118, KC-22128, KC-22138, KC-22148, KC-22158

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    PLUS SL

    FDA Adverse Event
    Injury ·SMITH & NEPHEW ORTHOPAEDICS AG·Product code KWY·November 5, 2008

    SUREFIX

    FDA Adverse Event
    Death ·MEDTRONIC PUERTO RICO, INC.·Product code DTB·August 24, 2011

    4000CMS

    FDA Adverse Event
    Malfunction ·MOOG DEVICE GROUP·Product code FRN·July 2, 2013

    VICRYL POLYGLACTIN 910 SUTURE UNKNOWN PRODUCT

    FDA Adverse Event
    Injury ·ETHICON INC.·Product code GAM·March 21, 2018

    Exactech Equinoxe REVERSE SHOULDER,38mm Constrained Humeral Liner: a) +0mm, Item Number 320-38-10, b) +2.5mm, Item Number 320-38-13, Shoulder Arthroplasty

    FDA Enforcement
    Class II ·Ongoing·Exactech, Inc.·April 10, 2024

    ACCOLADE DR SL MRI (Model L311)

    FDA Enforcement
    Class I ·Ongoing·Boston Scientific Corporation·October 22, 2025