BEUDAMED
    12 results · 20ms · Sources: EU EUDAMED, US FDA

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    ProBeam 360 Proton Therapy System v3.0

    FDA 510(k)
    FDA Class 2 ·Radiology

    NA

    FDA UDI
    Exactech, Inc.·10885862552402·TRIAL, TIBIAL SPACER, SIZE 3-4.5, 15mm

    Zavation

    FDA UDI
    Zavation LLC·00842166140776·End Plate - 25x28 Oval, 15°

    QMS AMIKACIN REAGENTS

    FDA 510(k)
    FDA Class 2 ·Clinical Toxicology

    Mailuokang Self-adhesive Electrode

    FDA 510(k)
    FDA Class 2 ·Neurology

    TVT EXACT RETROPUBIC SYSTEM

    FDA Adverse Event
    Injury ·CALDERA MEDICAL INC.·Product code OTN·October 22, 2025

    SYNERGY VERSITREL

    FDA Adverse Event
    Malfunction ·MEDTRONIC MED REL MEDTRONIC PUERTO RICO·Product code LGW·March 11, 2015

    CANCELLOUS SCREW 4.0 X 18 MM

    FDA Adverse Event
    Injury ·STRYKER OSTEOSYNTHESIS SELZACH·Product code HWC·December 4, 2008

    RESTORATION ADM X3 INS 28/52

    FDA Adverse Event
    Injury ·STRYKER ORTHOPAEDICS CORK·Product code MEH·September 13, 2011

    UNK

    FDA Adverse Event
    Injury ·ETHICON INC.·Product code FTL·July 29, 2013

    Exactech Equinoxe REVERSE SHOULDER,42mm Constrained Humeral Liner, a) +0mm, Item number 320-42-10, b) +2.5mm, Item Number 320-42-13; Shoulder Arthroplasty

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

    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