BEUDAMED
    14 results · 28ms · Sources: EU EUDAMED, US FDA

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    LOGIQ Totus

    FDA 510(k)
    FDA Class 2 ·Radiology

    VERIQA

    FDA 510(k)
    FDA Class 2 ·Radiology

    Caspian OCT/MESA Mini/DENALI Mini Spinal System

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    G7 OSSEOTI 4 HOLE SHELL 60MM G

    FDA Adverse Event
    Malfunction ·ZIMMER BIOMET, INC.·Product code OQI·March 25, 2020

    G7 BALL HEX DRVR FOR INSR HNDL

    FDA Adverse Event
    Malfunction ·ZIMMER BIOMET, INC.·Product code LPH·March 25, 2020

    UNKNOWN IMPACTOR

    FDA Adverse Event
    Malfunction ·ZIMMER BIOMET, INC.·Product code LXH·July 18, 2023

    CARPENTIER-EDWARDS PERIMOUNT PERICARDIAL BIOPROSTHESIS

    FDA Adverse Event
    Injury ·EDWARDS LIFESCIENCES·Product code LWR·December 2, 2008

    CURLIN ADMINISTRATION SET

    FDA Adverse Event
    Malfunction ·MOOG MEDICAL DEVICES GROUP·Product code FRN·August 3, 2011

    TOTAL ASR ACET IMP SIZE 58

    FDA Adverse Event
    Injury ·DEPUY INTL., LTD. - 8010379·Product code KWA·July 29, 2013

    COMPREHENSIVE REVERSE COBALT CHROME +5 HUMERAL TRAY

    FDA Adverse Event
    Injury ·ZIMMER BIOMET, INC.·Product code KWS·August 15, 2018

    G7 STR INSRTR THREADED SHAFT

    FDA Adverse Event
    Malfunction ·ZIMMER BIOMET, INC.·Product code LPH·March 25, 2020

    COMPREHENSIVE HUMERAL STEM¿MINI

    FDA Adverse Event
    Injury ·ZIMMER BIOMET, INC.·Product code MBF·August 15, 2018

    COMPREHENSIVE REVERSE GLENOSPHERE STANDARD

    FDA Adverse Event
    Injury ·ZIMMER BIOMET, INC.·Product code PAO·August 15, 2018

    Boston Scientific TELIGEN, Implantable Cardiac Defibrillator models E102, E110, the following models are not available in the US: models E103, E111, F102, F103, F110, F111. Sterilized using ethylene oxide. Product Usage: This family of implantable cardioverter defibrillators (ICDs) provide a variety of therapies including: -Ventricular tachyarrhythmia therapy, which is used to treat rhythms associated with sudden cardiac death such as VT and VF; -Bradycardia pacing, including adaptive rate pacing, to detect and treat bradyarrhythmias and to provide cardiac rate support after defibrillation therapy. Boston Scientific implantable cardioverter defibrillators (ICDs) are indicated to provide ventricular antitachycardia pacing (ATP) and ventricular defibrillation for automated treatment of life-threatening ventricular arrhythmias

    FDA Enforcement
    Class II ·Terminated·Boston Scientific CRM Corp·October 29, 2014