BEUDAMED
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    CS 3D Imaging

    FDA 510(k)
    FDA Class 2 ·Radiology

    OSS™ Orthopedic Salvage System

    FDA UDI
    Biomet Orthopedics, LLC·00880304674899·

    MYLAB 90 ULTRASOUND IMAGING SYSTEM, MODEL 6100

    FDA 510(k)
    FDA Class 2 ·Radiology

    ACL TIGHTROPE DOUBLE BUNDLE

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    COMPRESS DEVICE CPS SM SPDL WITH PINS 600LBF

    FDA Adverse Event
    Injury ·ZIMMER BIOMET, INC.·Product code MBF·October 2, 2024

    ONETOUCHPING GLUCOSEMGMTSYSTEM

    FDA Adverse Event
    Malfunction ·ANIMAS CORPORATION·Product code LZG·October 8, 2014

    CARELINK

    FDA Adverse Event
    Malfunction ·RICE CREEK MFG·Product code DXY·June 7, 2013

    ACCESS

    FDA Adverse Event
    Malfunction ·BAXTER HEALTHCARE - MALTA·Product code FPA·July 6, 2011

    SL & SLi Series (Mod 15/18/20/25) Linear Accelerator Used for radiation therapy treatments of malignant neoplastics diseases.

    FDA Enforcement
    Class II ·Terminated·Elekta, Inc.·March 26, 2014

    Medtronic MiniMed(TM) Mio(TM) (MMT-921, 921T, 923, 923T, 925, 925T, 941, 941T, 943, 943T, 945, 945T, 961, 963, 963T, 965, 965T, 975, 975T)

    FDA Enforcement
    Class II ·Ongoing·Medtronic Inc.·November 29, 2017