BEUDAMED
    17 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.

    TRIACTIV SYSTEM

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    AOS CANNULATED CANCELLOUS SCREW, FULLY THREADED 7.0mm x 40mm

    FDA UDI
    ADVANCED ORTHOPAEDIC SOLUTIONS, INC.·00848665010190·

    N.A.

    FDA UDI
    Forestadent Bernhard Förster GmbH·EFOR20420401·Arch wires Titanol Superelastic Straight-Arch-F...

    SlimLine®

    FDA UDI
    ZIMMER SPINE, INC.·00889024404168·

    Arthrex®

    FDA UDI
    ARTHREX, INC.·00888867522541·Cannulated Canc Screw, FT, 7.0x40mm

    Intelliguides

    FDA UDI
    Mios Marketing, LLC·G2710420420400·Anterio Lateral Closing Wedge Osteotomy Guide, ...

    Intelliguides

    FDA UDI
    Mios Marketing, LLC·G2710410420400·Anterior Closing Wedge Osteotomy Guide, 42mm x ...

    Intelliguides

    FDA UDI
    Mios Marketing, LLC·G2710400420400·Anterior Dome Osteotomy Guide, 42mm x 40mm

    FMS SOLO

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    RAMP MYOGLOBIN ASSAY

    FDA 510(k)
    FDA Class 2 ·Immunology

    SINGLE USE ASPIRATION NEEDLE

    FDA Adverse Event
    Malfunction ·OLYMPUS MEDICAL SYSTEMS CORP.·Product code FCG·April 5, 2013

    DEXTRUS 4136

    FDA Adverse Event
    Injury ·BIOTRONIK SE & CO. KG·Product code NVZ·March 29, 2011

    EASYTRAK 2

    FDA Adverse Event
    Malfunction ·CARDIAC PACEMAKERS, INC·Product code DTB·May 8, 2008

    Automated Impella Controller (AIC), product number 0042-040-US with software versions V8.4 and V8.4.1.

    FDA Enforcement
    Class II ·Terminated·Abiomed, Inc.·December 13, 2023

    Automated Impella Controller (AIC), product number 0042-040-US with software versions V8.4 and V8.4.1.

    FDA Recall
    Terminated ·Abiomed, Inc.·Product code OZD·October 10, 2023

    Unify Assura, Sterile EO, Model #/ Part #: CD3257-40/100042333, 100059944; CD3257-40Q/100042334, 100059936; CD3261-40/100048460, 100048546, 100059897, 100059954, 100059996, 100078828; CD3261-40Q/100048568, 100048581, 100059898, 100059955, 100059997, 100078853; CD3357-40C/100080408, 100080424, 100083511; CD3357-40Q/100080419, 100080463, 100083504; CD3361-40/100078842, 100079211, 100083506, 100096893; CD3361-40C/100078604, 100079159, 100079160, 100079338, 100083429, 100083514, 100117625; CD3361-40Q/100078805, 100079222, 100079456, 100083523, 100098067; CD3361-40QC/100078654, 100079202, 100079221, 100083475, 100083515, 100117558; CD3389-40C/100080778; CD3389-40QC/100080780, 100105489

    FDA Enforcement
    Class II ·Terminated·St Jude Medical Inc.·July 4, 2018

    Quadra Assura, Model No. CD3265-40, CD3265-40Q, CD3365-40C, CD3365-40Q. Quadra Assura MP, Model No. CD3269-40, CD3269-40Q, CD3369-40C. Fortify and Fortify Assura implantable cardioverter defibrillators (ICDS) are intended to provided ventricular anti-tachycardia pacing and ventricular defibrillation for automated treatment of life threatening ventricular arrhythmias. The devices may also be programmed to provide single or dual chamber bradycardia pacing. Unify and Unify Assura cardiac resynchronization therapy defibrillators (CRTDs) are intended to provide ventricular anti-tachycardia pacing and ventricular defibrillation for automated treatment of life-threatening ventricular arrhythmias. The devices may also be programmed to provide single or dual chamber bradycardia pacing, in additional to cardiac resynchronization therapy via left ventricular pacing

    FDA Enforcement
    Class I ·Terminated·St Jude Medical Inc.·November 2, 2016