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

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    URETHRAL CATHETERIZATION TRAY

    FDA 510(k)
    FDA Class 2 ·Gastroenterology, Urology

    TAMARACK ANTERIOR THORACOLUNBAR

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    Nautilus Spinal System

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    S3 ROLLER PUMP

    FDA Adverse Event
    Other ·SORIN GROUP DEUTSCHLAND (SORIN GROUP USA, INC. IS DISTRIBUTOR)·Product code DTQ·April 23, 2010

    3 TO 1 REDUCTION DRIVE

    FDA Adverse Event
    Other ·SORIN GROUP DEUTSCHLAND·Product code DTQ·December 14, 2011

    S3 ROLLER PUMP MODULE AND CONSOLE

    FDA Adverse Event
    Malfunction ·SORIN GROUP DEUTSCHLAND (SORIN GROUP USA, INC. IS DISTRIBUTOR·Product code DTQ·March 24, 2010

    3-TO-1 REDUCTION DRIVE

    FDA Adverse Event
    Other ·SORIN GROUP DEUTSCHMAND·Product code DTQ·December 14, 2011

    STOCKERT S3 CONSOLE

    FDA Adverse Event
    Other ·SORIN GROUP DEUTSCHLAND·Product code DTQ·October 6, 2011

    STOCKERT S3 CONSOLE

    FDA Adverse Event
    Other ·SORIN GROUP DEUTSCHLAND·Product code DTQ·October 6, 2011

    POINT 4 COMPOSITE

    FDA Adverse Event
    Injury ·KERR CORPORATION·Product code EBF·February 8, 2013

    VITALITY 2

    FDA Adverse Event
    Malfunction ·GUIDANT CRM CLONMEL IRELAND·Product code LWS·January 6, 2011

    G4 PLATINUM CONTINUOUS GLUCOSE MONITORING SYSTEM

    FDA Adverse Event
    Malfunction ·DEXCOM, INC.·Product code MDS·July 22, 2014

    SENSOR, LOW LEVEL II

    FDA Adverse Event
    Malfunction ·SORIN GROUP DEUTSCHLAND·Product code DTQ·April 16, 2010

    S3 ROLLER PUMP

    FDA Adverse Event
    Other ·SORIN GROUP DEUTSCHLAND (SORIN GROUP USA, INC. IS DISTRIBUTOR)·Product code DTQ·April 23, 2010

    S3 ROLLER PUMP

    FDA Adverse Event
    Malfunction ·SORIN GROUP DEUTSCHLAND·Product code DTQ·April 22, 2010

    S3 ROLLER PUMP

    FDA Adverse Event
    SORIN GROUP DEUTSCHLAND·Product code DWB·October 12, 2016

    COMPREHENSIVE REVERSE HUMERAL TRAY 44MM

    FDA Adverse Event
    Injury ·BIOMET ORTHOPEDICS·Product code KWS·March 17, 2017

    BLOOD CARDIOPLEGIA INSERTS

    FDA Adverse Event
    Malfunction ·SORIN GROUP DEUTSCHLAND·Product code DTQ·March 24, 2010

    Comprehensive Reverse Shoulder System Humeral Tray Model 115340

    FDA Enforcement
    Class I ·Terminated·Zimmer Biomet, Inc.·February 22, 2017

    BIOMET StageOne Select, Hip Stem Cement Spacer Mold w/Reinforcement Cement, 11 X 200 MM, Silicone, Sterile, Item 431196.

    FDA Enforcement
    Class II ·Terminated·Biomet, Inc.·April 15, 2020