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

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    SYNTHES (USA) LCP PROXIMAL HUMERUS PLATES, LONG

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    CD HORIZON® Spinal System

    FDA UDI
    MEDTRONIC SOFAMOR DANEK, INC.·00885074032184·BONE SCREW 7041860 10 DEG ILC 8.5X60 TI

    PARASPA PARAFFIN BATH, PARASPAP MINI, PARASPA ULTRA

    FDA 510(k)
    FDA Class 2 ·Physical Medicine

    KEYST0NE MEDICAL PICC CATHETER

    FDA 510(k)
    FDA Class 2 ·General Hospital

    OT ULTRALINK METER

    FDA Adverse Event
    Malfunction ·LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL·Product code NBW·April 8, 2013

    VITALITY DR

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

    PRECISION XTRA

    FDA Adverse Event
    Malfunction ·Product code NBW·April 6, 2011

    RANAWAT/BURSTEIN TOTAL HIP SYSTEM

    FDA Adverse Event
    Injury ·BIOMET ORTHOPEDICS·Product code LPH·April 18, 2017

    100KGY E-POLY MAXROM ACETABULAR LINERS

    FDA Adverse Event
    Injury ·BIOMET ORTHOPEDICS·Product code JDI·April 18, 2017

    TAPERLOC COMPLETE

    FDA Adverse Event
    Injury ·BIOMET ORTHOPEDICS·Product code KWA·April 18, 2017

    EVOLUT FX DCS

    FDA Adverse Event
    Malfunction ·MEDTRONIC HEART VALVES DIVISION·Product code NPT·April 10, 2025

    UNKNOWN VALVE/SHUNT

    FDA Adverse Event
    Injury ·MEDTRONIC NEUROSURGERY·Product code JXG·June 24, 2019

    UNKNOWN NON-DELTA VALVE/SHUNT

    FDA Adverse Event
    Injury ·MEDTRONIC NEUROSURGERY·Product code JXG·June 24, 2019

    Roche MODULAR ANALYTICS EVO Serum Work Area (SWA), Operator's Manual Software Version 08-02; Filter label: Filter (N) Mat. No 03149773001, Contents 1, 768-320 Filter (N). Product Usage: Fully automated immunoassay analyzer intended for the in-vitro quantitative/qualitative determination of analytes in body fluids.

    FDA Enforcement
    Class II ·Terminated·Roche Diagnostics Operations, Inc.·June 25, 2014

    Exactech Equinoxe CAGE GLENOID,POSTERIOR AUGMENT, CEMENTED, Left, Mates with: a) 38, 41, 44, 47 head, Small, Item Number 314-13-22, b) 41, 44, 47, 50, head, Medium, Item Number 314-13-23, c) 44, 47, 50, 53 head, Large, Item Number 314-13-24, d) 44, 47, 50, 53 head, Extra Large, Item Number 314-13-25; Shoulder Arthroplasty

    FDA Enforcement
    Class II ·Ongoing·Exactech, Inc.·April 10, 2024

    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

    The Spirit Select Bed, Model 5700 Spirit Plus /with high rail siderail option

    FDA Enforcement
    Class II ·Terminated·Stryker Medical Division of Stryker Corporation·November 21, 2018