BEUDAMED
    9 results · 23ms · Sources: EU EUDAMED, US FDA

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    DHX-70H, XTG-70H

    FDA 510(k)
    FDA Class 2 ·Dental

    BREATH SHAKE

    FDA 510(k)
    FDA Class 2 ·Anesthesiology

    ATTAIN LDS 6216A LEFT-HEART DELIVERY SYSTEM, MODEL 6216A

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    PARADIGM REAL-TIME INSULIN INFUSION PUMP

    FDA Adverse Event
    Malfunction ·MEDTRONIC MINIMED·Product code OYC·November 3, 2014

    RECONSTRUCTION NAIL R1.5, TI, LEFT 10X300 MM X 12

    FDA Adverse Event
    Injury ·STRYKER OSTEOSYNTHESIS KIEL·Product code HSB·August 18, 2011

    CBL 5 LEAD, SNAP, SHLD, AAMI, CHEST RGD

    FDA Adverse Event
    Malfunction ·PHILIPS MEDICAL SYSTEMS·Product code MKJ·July 1, 2013

    Allura Xper FD10 - Catalog numbers: (1) 722003, (2) 722010, (3) 722026,

    FDA Enforcement
    Class I ·Ongoing·PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.·February 26, 2025

    OPTETRAK Comprehensive Knee System including OPTETRAK All-polyethylene UNI Tibial Components, Product Lines, 252-12-XX, 252-13-XX, 252-22-XX, 252-23-XX. NOTE: Information reflects Exactech recall expansion initiated on 02/07/2022.

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

    Model Number L111, ESSENTIO DR SL MRI Pacemaker

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