BEUDAMED
    23 results · 33ms · Sources: EU EUDAMED, US FDA

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    Scenium

    FDA 510(k)
    FDA Class 2 ·Radiology

    HHM

    FDA UDI
    Oticon A/S·05707131285232·H160V2, DESIGNRITE 10 WL DBL HHM

    APEX Revision Knee

    FDA UDI
    Omni Life Science, Inc.·00841690122685·Modular Stem 19mm x 125mm

    Ophthalmic Speculum

    FDA UDI
    KATENA PRODUCTS, INC.·00841668100066·TEMPORAL SPECULUM CLOSED WIRE

    ESI

    FDA UDI
    FTT MEDICAL, INC.·B3961501920·BUIE-HIRSCHMAN ANOSCOPE, MEDIUM. ACMI FITTING.

    BRC SOFTWARE PRODUCT

    FDA 510(k)
    FDA Class 2 ·Neurology

    STRONG DENTAL HANDPIECES

    FDA 510(k)
    FDA Class 1 ·Dental

    T:SLIM X2 INSULIN PUMP WITH BASAL-IQ TECHNOLOGY

    FDA Adverse Event
    Malfunction ·TANDEM DIABETES CARE·Product code OZO·January 30, 2020

    T:SLIM X2 INSULIN PUMP WITH CONTROL-IQ TECHNOLOGY

    FDA Adverse Event
    Malfunction ·TANDEM DIABETES CARE·Product code QFG·January 18, 2022

    AXIOS

    FDA Adverse Event
    Injury ·BOSTON SCIENTIFIC CORPORATION·Product code KNS·December 18, 2024

    AXIOS

    FDA Adverse Event
    Malfunction ·BOSTON SCIENTIFIC CORPORATION·Product code KNS·February 19, 2025

    AXIOS

    FDA Adverse Event
    Malfunction ·BOSTON SCIENTIFIC CORPORATION·Product code KNS·December 17, 2024

    AXIOS

    FDA Adverse Event
    Injury ·BOSTON SCIENTIFIC CORPORATION·Product code KNS·February 20, 2025

    3.5mm Non Locking Cortical Screw, in the PediLoc Tibial Plate System Part number 00-0903-2510, 3.5mm x 10mm Non Locking Cortical Screw. Used in pediatric orthopedics.

    FDA Recall
    Terminated ·OrthoPediatrics Corp·Product code HRS·July 28, 2015

    3.5mm Non Locking Cortical Screw, in the PediLoc Tibial Plate System Part number 00-0903-2510, 3.5mm x 10mm Non Locking Cortical Screw. Used in pediatric orthopedics.

    FDA Enforcement
    Class II ·Terminated·OrthoPediatrics Corp·September 30, 2015

    AXIOS

    FDA Adverse Event
    Injury ·BOSTON SCIENTIFIC CORPORATION·Product code KNS·December 18, 2024

    MECHANICAL (MANUAL) WHEELCHAIR

    FDA Adverse Event
    Malfunction ·INVAMEX·Product code IOR·October 7, 2014

    COLLEAGUE PRE P1.7

    FDA Adverse Event
    Malfunction ·BAXTER HEALTHCARE - SINGAPORE·Product code FRN·July 6, 2011

    HOLDING SLEEVE-STANDARD FOR MATRIX

    FDA Adverse Event
    Injury ·SYNTHES MONUMENT·Product code LXH·June 6, 2013

    UNKNOWN HIP FEMORAL STEM

    FDA Adverse Event
    Injury ·DEPUY ORTHOPAEDICS INC US·Product code KWA·October 14, 2019