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

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    Cardiac Workstation (5000); Cardiac Workstation (7000)

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    SPINAL VERTEBRAL BODY REPLACEMENT DEVICE

    FDA Adverse Event
    Injury ·MEDTRONIC SOFAMOR DANEK·Product code MQP·October 30, 2017

    AVREO INTERWORKS SYSTEM

    FDA 510(k)
    FDA Class 2 ·Radiology

    MODIFICATION TO VERTE-STACK SPINAL SYSTEM

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    VERTE-STACK SPINAL SYSTEM

    FDA Adverse Event
    Malfunction ·SOFAMOR DANEK DEGGENDORF GMBH·Product code MQP·January 21, 2010

    VERTE-STACK SPINAL SYSTEM

    FDA Adverse Event
    Malfunction ·SOFAMOR DANEK DEGGENDORF GMBH·Product code ODP·November 20, 2009

    PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP

    FDA Adverse Event
    Malfunction ·MEDTRONIC PUERTO RICO OPERATIONS CO.·Product code OYC·November 10, 2014

    NC TREK CORONARY DILATATION CATHETER

    FDA Adverse Event
    Malfunction ·AV-TEMECULA-CT·Product code LOX·September 9, 2011

    PROLENE HERNIA SYSTEM MESH

    FDA Adverse Event
    Injury ·ETHICON INC.·Product code FTL·July 22, 2013

    UNIVERSAL Modular Electric/Battery Handpiece for surgery The electric handpiece is packaged within a foam bag inside of a padded-foam corrugate box. An operating manual is packed with the handpiece between the top foam pad and box lid. A product label is applied to the lid of the box. Product Usage: Surgical instrument motors and accessories are AC-powered, battery-powered, or air-powered devices intended for use during surgical procedures to provide power to operate various accessories or attachments to cut hard tissue or bone and soft tissue. Accessories or attachments may include a bur, chisel (osteotome), dermabrasion brush, dermatome, drill bit, hammerhead, pin driver, and saw blade.

    FDA Enforcement
    Class II ·Terminated·Zimmer Surgical Inc·November 12, 2014

    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