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

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    FLEXTIME

    FDA 510(k)
    FDA Class 2 ·Dental

    PowerPICC

    FDA UDI
    Bard Access Systems, Inc.·00801741126512·Catheter Placemen Kit

    Henry Schein

    FDA UDI
    HENRY SCHEIN, INC.·00304040128992·Hemostat Rochester-Pean 6-1/4"

    LEGION

    FDA UDI
    Smith & Nephew, Inc.·00885556706381·OXINIUM LEGION HK FEMORAL SIZE 4 LEFT

    LEGION

    FDA UDI
    Smith & Nephew, Inc.·00885556706398·OXINIUM LEGION HK TITANIUM TIBIAL ...

    LEGION

    FDA UDI
    Smith & Nephew, Inc.·00885556706404·OXINIUM LEGION HK THREADED AXLE ...

    LEGION

    FDA UDI
    Smith & Nephew, Inc.·00885556706411·SLOTTED SCREWDRIVER

    STELA UT46 AND BT45/46 STRAIGHT TINED PACING LEADS, STELA UJ45 AND BJ44/45 J-SHAPED TINED PACING LEADS

    FDA 510(k)
    FDA Class 3 ·Cardiovascular

    VIDEOLABS MEDCAM PROPLUS VIDEO CAMERA AND INTEGRAL LIGHT SOURCE

    FDA 510(k)
    FDA Class 2 ·Gastroenterology, Urology

    GMK-PRIMARY TIBIAL TRAY FIXED CEMENTED SIZE 3 L

    FDA Adverse Event
    Injury ·MEDACTA INTERNATIONAL SA·Product code JWH·January 5, 2024

    GMK-SPHERE TIBIAL INSERT FIXED SPHERE FLEX SIZE 3/12 MM R

    FDA Adverse Event
    Injury ·MEDACTA INTERNATIONAL SA·Product code JWH·October 26, 2023

    GMK-SPHERE 02.12.0312FL TIBIAL INSERT FIXED SPHERE FLEX SIZE 3/12 MM L

    FDA Adverse Event
    Injury ·MEDACTA INTERNATIONAL SA·Product code JWH·April 8, 2022

    POWERED WHEELCHAIR

    FDA Adverse Event
    Malfunction ·INVACARE TAYLOR STREET·Product code ITI·March 12, 2013

    POWERED WHEELCHAIR

    FDA Adverse Event
    Malfunction ·INVACARE·Product code ITI·February 2, 2011

    GE OEC 9800

    FDA Adverse Event
    Malfunction ·GE OEC MEDICAL SYSTEMS INC.·Product code JAA·February 21, 2008

    The AlignRT InBore system contains six Class 1 lasers which enables the system s cameras to track the patient s position and movement.

    FDA Enforcement
    Class II ·Ongoing·Vision RT Ltd·January 14, 2026

    BrightView SPECT (Uninterruptible Power Supply (UPS) accessory devices) Computed Tomography X-ray systems and Diagnostic Imaging systems.

    FDA Enforcement
    Class II ·Terminated·Philips Medical Systems (Cleveland) Inc·June 17, 2015

    CS Uni-Directional w Auto ID, Product Number D135303; REPROCESSED ELECTROPHYSIOLOGY CATHETER

    FDA Enforcement
    Class II ·Ongoing·Stryker Sustainability Solutions·May 20, 2026

    BrightView, Gamma Camera System, Product Code 882480.

    FDA Enforcement
    Class II ·Ongoing·Philips North America·January 17, 2024

    BrightView are gamma cameras; Designed for single or dual detector nuclear imaging.

    FDA Enforcement
    Class II ·Terminated·Philips Medical Systems (Cleveland) Inc·March 9, 2016