BEUDAMED
    15 results · 29ms · Sources: EU EUDAMED, US FDA

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    SwiftNINJA Steerable Microcatheter

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    Phasix

    FDA UDI
    Davol Inc.·00801741161261·Phasix ST Mesh with Echo 2 Positioning System, ...

    MEDI

    FDA UDI
    MEDI MANUFACTURING, INC.·04051526189744·LEVAMED ACTIVE ANKLE SUP BLACK L V

    APPLE ECG (ELECTROCARDIOGRAPH) APP

    FDA Adverse Event
    Injury ·APPLE INC.·Product code QDA·July 5, 2023

    PERIMETER INTERBODY FUSION DEVICE

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    SAFE AT HOME TSH (THYROID STIMULATING HORMONE BLOOD COLLECTION AND TRANSPORT SYSTEM)

    FDA 510(k)
    FDA Class 2 ·Clinical Chemistry

    NOVUM IQ

    FDA Adverse Event
    Malfunction ·BAXTER HEALTHCARE CORPORATION·Product code FRN·January 13, 2025

    XIENCE V EVEROLIMUS ELUTING CORONARY STENT SYSTEM

    FDA Adverse Event
    Injury ·ABBOTT VASCULAR-CARDIAC THERAPIES·Product code NIQ·October 22, 2008

    UNICEL DXC 800 SYNCHRON SYSTEM

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

    TALENT TAA STENT GRAFT

    FDA Adverse Event
    Death ·MEDTRONIC IRELAND·Product code MIH·July 8, 2013

    CORTSCR Ø1.5 SELF-TAP L10

    FDA Adverse Event
    Malfunction ·SYNTHES GRENCHEN·Product code MQN·March 3, 2015

    CORTSCR Ø1.5 SELF-TAP L10

    FDA Adverse Event
    Malfunction ·SYNTHES GRENCHEN·Product code MQN·March 3, 2015

    Model Number L211 PROPONENT DR SL MRI Pacemaker

    FDA Enforcement
    Class I ·Ongoing·Boston Scientific Corporation·October 22, 2025

    PROPONENT DR Pacemaker, SL (Model Number L201), (VDD) SL (Model Number L209), SL MRI (Model Number L211), EL (Model Number L221), and EL MRI (Model Number L231).

    FDA Enforcement
    Class I ·Ongoing·Boston Scientific Corporation·January 22, 2025

    Alcon Custom Pak

    FDA Enforcement
    Class II ·Ongoing·Alcon Research, LTD.·August 23, 2023