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

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    RODO Abutment System

    FDA 510(k)
    FDA Class 2 ·Dental

    REZUM

    FDA Adverse Event
    Injury ·BOSTON SCIENTIFIC CORPORATION·Product code KNS·April 23, 2024

    SYNTHETIC (YELLOW) VINYL PATIENT EXAMINATION GLOVE-POWDER FREE

    FDA 510(k)
    FDA Class 1 ·General Hospital

    MICROTHERMX MICROWAVE ABLATION SYSTEM, MODELS MTX-180 OR MTX

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

    RIATA PASSIVE FIXATION LEAD

    FDA Adverse Event
    Injury ·ST. JUDE MEDICAL INC., CARDIAC RHYTHM MANAGEMENT D·Product code LWS·January 13, 2014

    ONETOUCHPING GLUCOSEMGMTSYSTEM

    FDA Adverse Event
    Malfunction ·ANIMAS CORPORATION·Product code LZG·June 10, 2013

    UNKNOWN TIBIA

    FDA Adverse Event
    Injury ·ZIMMER, INC.·Product code JWH·July 7, 2011

    SLEEK OTW PTA CATHETER

    FDA Adverse Event
    Injury ·CLEARSTREAM TECHNOLOGIES LTD.·Product code DQY·December 13, 2023

    OEC 6800 Miniview, Image-intensified fluoroscopic x-ray system used during diagnostic, surgical and interventional procedures. Designed to provide the physician with general fluoroscopic visualization of the patient including but not limited to surgical orthopedic and extremity imagine. The device is not intended for whole-body pediatric imaging.

    FDA Enforcement
    Class I ·Terminated·GE OEC Medical Systems, Inc·August 1, 2012