BEUDAMED
    9 results · 19ms · Sources: EU EUDAMED, US FDA

    Get notified when this changes

    We'll email you when new records match this search — new devices, new clearances, certificate changes, or withdrawals.
    Filters Regulation: Us FDA ×

    Syntec Femoral Nail System

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    HAMILTON-C1

    FDA Adverse Event
    Malfunction ·HAMILTON MEDICAL AG·Product code CBK·August 30, 2024

    ZIMMER SEGMENTAL SYSTEM PROXIMAL FEMORAL COMPONENT AND SMALL DIAMETER STEM EXTENSIONS

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    PREFERENCE PEDICLE SCREW SYSTEM

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    530G INSULIN PUMP

    FDA Adverse Event
    Malfunction ·MEDTRONIC PUERTO RICO OPERATIONS CO.·Product code OZO·October 17, 2014

    HEARTMATE II LVAS

    FDA Adverse Event
    Injury ·THORATEC CORP.·Product code DSQ·June 13, 2013

    UNKNOWN CATHETER

    FDA Adverse Event
    Injury ·MEDTRONIC NEUROSURGERY·Product code JXG·July 21, 2011

    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

    OPTETRAK Comprehensive Knee System including OPTETRAK Logic RBK PS Tibial Components (Product Line: 02-012-38-XXXX). NOTE: Information reflects Exactech recall expansion initiated on 02/07/2022.

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