BEUDAMED
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    ST AIA-PACK PROG III Calibrator Set

    FDA 510(k)
    FDA Class 2 ·Clinical Chemistry

    HALIFAX BIOMEDICAL TANATLUM BEAD SET

    FDA 510(k)
    FDA Class 2 ·General, Plastic Surgery

    M-COR HIP REPLACEMENT SYSTEM

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    AMISTEM H COATED STD STEM SIZE 1

    FDA Adverse Event
    Injury ·MEDACTA INTERNATIONAL SA·Product code LZO·September 22, 2020

    PARADIGM REAL-TIME INSULIN INFUSION PUMP

    FDA Adverse Event
    Malfunction ·MEDTRONIC PUERTO RICO OPERATIONS CO.·Product code OYC·October 8, 2014

    ALTRUA

    FDA Adverse Event
    Malfunction ·GUIDANT CRM CLONMEL IRELAND·Product code NVZ·July 7, 2011

    CARELINK

    FDA Adverse Event
    Malfunction ·RICE CREEK MFG·Product code DXY·June 8, 2013

    ELEKTA LIMITED Versa HD, REF XRT 2121, 2131; Medical Charged-Particle Radiation Therapy System Accelerator, Linear

    FDA Enforcement
    Class II ·Ongoing·Elekta, Inc.·December 13, 2023