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

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    Integrity-SI TM Fusion System

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    OsteoMed

    FDA UDI
    OSTEOMED LLC·00845694047364·PrimaLIF LLIF PEEK Implant, 17mm X 22mm X 55mm,...

    MYLAB15/20 NEW INDICATIONS ULTRASOUND SYSTEM

    FDA 510(k)
    FDA Class 2 ·Radiology

    AIDI DENTAL IMPLANT SYSTEM

    FDA 510(k)
    FDA Class 2 ·Dental

    CAPSURE SP NOVUS

    FDA Adverse Event
    Malfunction ·MPRI·Product code DTB·October 10, 2014

    PARADIGM REAL-TIME INSULIN INFUSION PUMP

    FDA Adverse Event
    Injury ·MEDTRONIC MINIMED·Product code MDS·July 8, 2011

    IMPAX CV REPORTING

    FDA Adverse Event
    Malfunction ·AGFA HEALTHCARE CORP.·Product code LLZ·June 11, 2013

    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