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

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    TrueBeam, TrueBeam STx, EDGE and VitalBeam (4.1)

    FDA 510(k)
    FDA Class 2 ·Radiology

    Dornier MedTech

    FDA UDI
    DORNIER MEDTECH AMERICA, INC.·00810116022724·Dornier 600 µm Single-Use SMA Diode Laser Fiber...

    Origio Gas Line Filter

    FDA 510(k)
    FDA Class 2 ·Obstetrics/Gynecology

    TLC Unicompartmental Knee System

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    SURESCAN

    FDA Adverse Event
    Malfunction ·MEDTRONIC MED REL MEDTRONIC PUERTO RICO·Product code LGW·November 6, 2014

    GO BED PLUS

    FDA Adverse Event
    Malfunction ·STRYKER MEDICAL·Product code FNL·July 19, 2011

    PULSE GEN MODEL 103

    FDA Adverse Event
    Injury ·CYBERONICS, INC.·Product code LYJ·July 18, 2013

    CPS TAPER LOCKING CAP / OSS SC

    FDA Adverse Event
    Injury ·ZIMMER BIOMET, INC.·Product code KWA·March 5, 2018

    OSS RS NON MOD PLATE LONG 67

    FDA Adverse Event
    Injury ·ZIMMER BIOMET, INC.·Product code KRO·March 5, 2018

    NEEDLE SFTYGLD 25X1 RB

    FDA Adverse Event
    Malfunction ·BECTON DICKINSON MEDICAL SYSTEMS·Product code FMI·October 27, 2020

    CPS 10CM SEG FM OSS TPR LT

    FDA Adverse Event
    Injury ·ZIMMER BIOMET, INC.·Product code JDI·October 23, 2017

    Natural-Knee System Patella Bushings Orthopedic surgical instrument. Part Number 6290-00-704. Per the Natural-Knee II Primary System Surgical Technique, the patellar bushing is placed on the cut surface of the patella and used as a guide for the matching size patella cutter

    FDA Enforcement
    Class II ·Terminated·Zimmer, Inc.·September 10, 2014

    Vantage Total Ankle System including a. Vantage Fixed-Bearing Polyethylene Liner Component (Product Line: 350-21-XX, 350-22-XX); b. Vantage Mobile-Bearing Polyethylene Liner Component (Product Line: 350-41-XX, 350-42-XX). NOTE: Information reflects Exactech recall expansion initiated on 02/07/2022.

    FDA Enforcement
    Class II ·Ongoing·Exactech, Inc.·October 13, 2021