BEUDAMED
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    SYNGO.PLAZA VB10A

    FDA 510(k)
    FDA Class 2 ·Radiology

    Ophthalmic Spatula

    FDA UDI
    KATENA PRODUCTS, INC.·00841668103166·GUIMARAES CORNEAL SPATULA

    K133532

    FDA Adverse Event
    Malfunction ·CAREFUSION SD·Product code FRN·February 2, 2021

    Aileron Posterior Fusion System

    FDA UDI
    Life Spine, Inc.·00190837000196·

    Aileron Posterior Fusion System

    FDA UDI
    Life Spine, Inc.·00190837030537·Core, Static Aileron, Medium Barrel, 12mm

    Aileron Posterior Fusion System

    FDA UDI
    Life Spine, Inc.·00190837030544·Core, Static Aileron, No Bullet, 12mm

    Aileron Posterior Fusion System

    FDA UDI
    Life Spine, Inc.·00190837030520·AILERON Static Posterior Fusion Core, Short Bar...

    Aileron Posterior Fusion System

    FDA UDI
    Life Spine, Inc.·00190837000189·

    Aileron Posterior Fusion System

    FDA UDI
    Life Spine, Inc.·00190837030551·Plate, Static Aileron, No Bullet, 12mm

    HLS CANNULA NON-COATED, WITH BIOLINE COATING AND WITH SOFTLINE COATING

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    TARAS THREADED FIXATION PIN

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM

    FDA Adverse Event
    Malfunction ·DEXCOM, INC.·Product code QBJ·May 29, 2025

    FLEXOR RADIAL ACCESS SET

    FDA Adverse Event
    Injury ·COOK, INC.·Product code DYB·April 13, 2015

    PORTABLE OXYGEN GENERATOR (CONCENTRATOR, HOMEFILL)

    FDA Adverse Event
    Malfunction ·INVACARE FLORIDA OPERATIONS·Product code CAW·October 1, 2014

    OT VERIO IQ METER

    FDA Adverse Event
    Malfunction ·LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL·Product code NBW·May 29, 2013

    COULTER LH500

    FDA Adverse Event
    Malfunction ·BECKMAN COULTER, INC.·Product code GKZ·June 17, 2011

    FLEXOR RADIAL ACCESS SET

    FDA Adverse Event
    Injury ·COOK INC·Product code DYB·July 12, 2016

    IOL Master 500: Software versions 7.5 and 7.7; Ophthalmic: IOL Master 500 is intended for biometric determination of ocular measurements of axial length, anterior chamber depth, corneal radius, white-to white (WTW), and for the measurement of pupil size and deviation of the visual axis from the center of the pupil.

    FDA Enforcement
    Class II ·Terminated·Carl Zeiss Meditec AG·December 9, 2015