BEUDAMED
    14 results · 21ms · Sources: EU EUDAMED, US FDA

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    KOPANS HOOKWIRE LESION LOCALIZATION NEEDLE

    FDA 510(k)
    FDA Class 1 ·General, Plastic Surgery

    BONE-LOK MVP Cortical-Cancellous Compression Device

    FDA UDI
    INTERVENTIONAL SPINE, INC·81195401188848·4.5mm Diameter x 50-60mm Length

    ANTI-HAV

    FDA 510(k)
    FDA Class 2 ·Microbiology

    ADDITIONAL ASSAYS FOR BAYER ADVIA IMS SYSTEM

    FDA 510(k)
    FDA Class 2 ·Clinical Toxicology

    GEENEN PANCREATIC STENT SET

    FDA Adverse Event
    Injury ·COOK IRELAND LTD·Product code FGE·January 10, 2019

    PARADIGM REAL-TIME INSULIN INFUSION PUMP

    FDA Adverse Event
    Malfunction ·MEDTRONIC PUERTO RICO OPERATIONS CO.·Product code OYC·June 27, 2014

    KLEENSPEC 590 SERIES DISP VAGINAL SPECULA

    FDA Adverse Event
    Malfunction ·WELCH ALLYN, INC.·Product code HIB·November 10, 2010

    9800

    FDA Adverse Event
    Malfunction ·GE OEC MEDICAL SYSTEMS (SLC)·Product code JAA·December 13, 2012

    GEENEN PANCREATIC STENT

    FDA Adverse Event
    Injury ·COOK ENDOSCOPY·Product code FGE·September 14, 2018

    GEENEN PANCREATIC STENT

    FDA Adverse Event
    Injury ·COOK ENDOSCOPY·Product code FGE·September 14, 2018

    GEENEN PANCREATIC STENT

    FDA Adverse Event
    Injury ·COOK ENDOSCOPY·Product code FGE·September 14, 2018

    UNKNOWN

    FDA Adverse Event
    Malfunction ·COOK IRELAND LTD·Product code FGE·June 9, 2021

    ZIMMON PANCREATIC STENT

    FDA Adverse Event
    Malfunction ·COOK IRELAND LTD·Product code FGE·October 16, 2020

    Philips Azurion Interventional Fluoroscopic X-ray Systems, specifically the Disk Bay of the PC component of the affected system. Affected PCs: XRay PC, Suite PC, and FlexViewing PC Azurion Model Name - Model Number: Azurion 3 M12 722063 722221; Azurion 3 M15 722064 722222; Azurion 5 M20 722228; Azurion 7 B12 722067 722225; Azurion 7 B20 722068 722226; Azurion 7 M12 722078 722223; Azurion 7 M20 722079 722224;

    FDA Enforcement
    Class II ·Ongoing·PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.·February 28, 2024