BEUDAMED
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    10M - General Purpose

    FDA UDI
    Certified Safety Manufacturing, Inc.·00766588020143·General Purpose - 10 Metal

    Magnetom Aera, Magnetom Skyra, Magnetom Prisma/Prisma fit

    FDA 510(k)
    FDA Class 2 ·Radiology

    MAGNETOM Skyra (DE). Model Number: 10432915. 510(k) Numbers: K101347, K111242, K123510, K133435, K140253, K141977, K142515, K153343, K173592, K202014, K231560.

    FDA Recall
    Open, Classified ·Siemens Medical Solutions USA, Inc·Product code LNH·August 28, 2025

    MAGNETOM Skyra (DE). Model Number: 10432915. 510(k) Numbers: K101347, K111242, K123510, K133435, K140253, K141977, K142515, K153343, K173592, K202014, K231560.

    FDA Enforcement
    Class I ·Ongoing·Siemens Medical Solutions USA, Inc·October 8, 2025

    EVOS Lumbar Interbody System

    FDA UDI
    Cutting Edge Spine, LLC·00841193113463·HA PEEK EVOS Straight, ,14mmx8mmx 30mm , FLAT ...

    Conventional Lead Apron .5mm Xtra Large 25 X 40

    FDA UDI
    Flow X Ray Corporation·00843696123598·Conventional Lead Apron .5mm Xtra Large 25 X 40...

    Operon

    FDA UDI
    Berchtold Holding GmbH·07613327412697·Berchtold Surgical Table, D 820

    TENS STIMULATOR, MODELS 2800 AND 3000

    FDA 510(k)
    FDA Class 2 ·Neurology

    3D Predict

    FDA 510(k)
    FDA Class 2 ·Dental

    UNICEL DXC 600 SYNCHRON CLINICAL SYSTEM

    FDA Adverse Event
    Injury ·BECKMAN COULTER, INC.·Product code JGS·August 5, 2011

    PARADIGM REAL-TIME INSULIN INFUSION PUMP

    FDA Adverse Event
    Malfunction ·MEDTRONIC MINIMED·Product code OYC·September 17, 2014

    INFUSE BONE GRAFT

    FDA Adverse Event
    Injury ·MEDTRONIC SOFAMOR DANEK USA, INC·Product code NEK·July 2, 2013

    COBALT¿ XT VR MRI SURESCAN¿

    FDA Adverse Event
    Injury ·MEDTRONIC EUROPE SARL·Product code LWS·December 16, 2024

    PIPELINE EMBOLIZATION DEVICE

    FDA Adverse Event
    Death ·EV3 NEUROVASCULAR·Product code OUT·July 17, 2014

    Safety glasses made with "Rage" frames manufactured between February 20, 2014 and February 25, 2014. The color of the frames of the recalled glasses were either white or black. Safety Eye wear

    FDA Recall
    Terminated ·Wal Mart Stores, Inc·Product code HQG·February 26, 2014

    PIPELINE EMBOLIZATION DEVICE

    FDA Adverse Event
    Injury ·EV3 NEUROVASCULAR·Product code OUT·July 17, 2014

    Safety glasses made with "Rage" frames manufactured between February 20, 2014 and February 25, 2014. The color of the frames of the recalled glasses were either white or black. Safety Eye wear

    FDA Enforcement
    Class II ·Terminated·Wal Mart Stores, Inc·June 25, 2014

    ENDURANT

    FDA Adverse Event
    Death ·MEDTRONIC CARDIOVASCULAR·Product code MIH·March 7, 2014

    TALENT AAA

    FDA Adverse Event
    Death ·MEDTRONIC CARDIOVASCULAR·Product code MIH·March 6, 2014

    HEARTMATE II LVAS

    FDA Adverse Event
    Death ·THORATEC CORP.·Product code DSQ·February 11, 2014