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

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    LED Light Therapy Device (HLGMZ-3W-G1V1,HLGMZ-3W-G2V1,HLG-GJXJ-G1V1,HGMZ-2W-G1V1, HGMZ-2W-G2V1,MRD-GJXJ-G1V1.)

    FDA 510(k)
    FDA Class 2 ·General, Plastic Surgery

    Truliant

    FDA UDI
    Exactech, Inc.·10885862556301·TRIAL, TIBIAL INSERT, CR, NEUTRAL, SIZE 3.5

    SYSMEX UF-100I AUTOMATED URINE CELL ANALYZER

    FDA 510(k)
    FDA Class 2 ·Hematology

    VITAL SIGNS MONITOR

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    IMPL TAPERED SCR-V SBM 3. 7MM 3.5MM 8MM

    FDA Adverse Event
    Injury ·ZIMMER DENTAL·Product code DZE·October 10, 2022

    DEXCOM G6 CONTINUOUS GLUCOSE MONITORING SYSTEM

    FDA Adverse Event
    Malfunction ·DEXCOM, INC.·Product code QBJ·September 10, 2025

    IMPL TAPERED SCR-V SBM 3. 7MM 3.5MM 8MM

    FDA Adverse Event
    Injury ·ZIMMER DENTAL·Product code DZE·October 3, 2024

    IMPL TAPERED SCR-V SBM 3. 7MM 3.5MM 8MM

    FDA Adverse Event
    Injury ·ZIMMER DENTAL·Product code DZE·October 3, 2024

    STEALTHSTATION® S7

    FDA Adverse Event
    Malfunction ·MEDTRONIC NAVIGATION, INC·Product code HAW·April 16, 2019

    IMPL TAPERED SCR-V SBM 3.7MM 3.5MM 10MM

    FDA Adverse Event
    Injury ·ZIMMER DENTAL·Product code DZE·November 15, 2023

    IMPL TAPERED SCR-V SBM 3.7MM 3.5MM 10MM

    FDA Adverse Event
    Injury ·ZIMMER DENTAL·Product code DZE·November 15, 2023

    IMP,TSV,4.1MM,SBM,10

    FDA Adverse Event
    Injury ·ZIMMER DENTAL·Product code DZE·November 15, 2023

    PULSE GEN MODEL 102

    FDA Adverse Event
    Injury ·CYBERONICS INC·Product code LYJ·December 5, 2008

    SONOPLEX STIM

    FDA Adverse Event
    Other ·PAJUNK GMBH MEDIZINTECHNOLOGIE·Product code BSP·August 23, 2011

    COULTER® ACT DIFF ANALYZER

    FDA Adverse Event
    Malfunction ·BECKMAN COULTER·Product code GKZ·July 29, 2013

    Ref No: INS5HND / Integra Cranial access kit (without Prep solutions) Bit and Guard. For access to the subarachnoid space or the lateral ventricles of the brain.

    FDA Enforcement
    Class II ·Ongoing·Integra LifeSciences Corp.·March 6, 2024

    IMPL TAPERED SCR-V SBM 3. 7MM 3.5MM 8MM

    FDA Adverse Event
    Injury ·ZIMMER DENTAL·Product code DZE·November 15, 2023

    IMP,TSV,4.1MM,SBM,10

    FDA Adverse Event
    Injury ·ZIMMER DENTAL·Product code DZE·November 15, 2023

    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