BEUDAMED
    15 results · 22ms · Sources: EU EUDAMED, US FDA

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    TROCHANTER CABLE GRIP SYSTEM (ADD'L INDICATIONS)

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    SCANLAN® V.I.P.™ Tunneler Sterilization Tray

    FDA UDI
    SCANLAN INTERNATIONAL INC·00846159023626·Tunneler Storage / Sterilization Tray, 1.5" x 3...

    EASYELECTROLYTE ANALYZER AND RAPIDLYTE ANALYZER

    FDA 510(k)
    FDA Class 2 ·Clinical Chemistry

    SMITH & NEPHEW RAIL SYSTEM

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    GEENEN PANCREATIC STENT SET

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

    LANCET DEVICE

    FDA Adverse Event
    Injury ·MEDTRONIC MINIMED·Product code MDS·June 27, 2014

    OBTRYX SYSTEM

    FDA Adverse Event
    Injury ·BOSTON SCIENTIFIC - MARLBOROUGH·Product code FTL·November 17, 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

    TLIIQ FETAL FIBRONECTIN TEST

    FDA Adverse Event
    Injury ·HOLOGIC, INC.·Product code LKV·May 30, 2025

    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