BEUDAMED
    12 results · 23ms · Sources: EU EUDAMED, US FDA

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    Oral-B 5% Sodium Fluoride Varnish

    FDA 510(k)
    FDA Class 2 ·Dental

    AGC KNEE SYSTEM

    FDA UDI
    Biomet Orthopedics, LLC·00880304222038·

    CARDIO MED

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    AVEX CX2 AND AVEX CXI2 CERAMIC BRACKETS

    FDA 510(k)
    FDA Class 2 ·Dental

    FREESTYLE PRECISION NEO H

    FDA Adverse Event
    Injury ·ABBOTT DIABETES CARE INC.·Product code NBW·May 25, 2016

    SPRINT

    FDA Adverse Event
    Injury ·MPRI·Product code LWS·June 8, 2013

    VISIAN ICL (IMPLANTABLE COLLAMER LENS)

    FDA Adverse Event
    Injury ·STAAR SURGICAL CO.·Product code MTA·June 30, 2011

    PULSE GEN MODEL UNK

    FDA Adverse Event
    Injury ·CYBERONICS, INC.·Product code LYJ·September 5, 2008

    UNKNOWN XMTR

    FDA Adverse Event
    Malfunction ·MEDTRONIC MINIMED·Product code MDS·April 11, 2025

    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

    ELEKTA LIMITED Elekta Synergy Platform, REF MRT 8501, MRT 8511; Medical Charged-Particle Radiation Therapy System Accelerator, Linear

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