BEUDAMED
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    Medtronic Legend Pneumatic; MR7 Pneumatic; Triton Pneumatic Drill System incorporating various Pneumatic Handpieces; Attachments; Surgical Dissecting Tools; and System Accessories

    FDA 510(k)
    FDA Class 2 ·Neurology

    APPLIANCE, FIXATION, SPINAL INTERLAMINAL

    FDA Adverse Event
    Death ·MEDTRONIC SOFAMOR DANEK USA, INC.·Product code KWP·March 22, 2020

    TRIANA, PICTURE ARCHIVING AND COMMUNICATIONS SYSTEM

    FDA 510(k)
    FDA Class 2 ·Radiology

    ENPATH MEDICAL VIASEAL VALVED PEELABLE INTRODUCER, MODEL 10866-XXX

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    EVIS EXERA III DUODENOVIDEOSCOPE

    FDA Adverse Event
    Injury ·OLYMPUS MEDICAL SYSTEMS CORP.·Product code FDT·February 18, 2022

    VIRTUOSO II DR

    FDA Adverse Event
    Injury ·MEDTRONIC MED REL MEDTRONIC PUERTO RICO·Product code LWS·October 10, 2014

    PROLIFT PELVIC FLOOR REPAIR

    FDA Adverse Event
    Injury ·ETHICON, INC.·Product code OTP·June 11, 2013

    ASR ACETABULAR CUPS 56

    FDA Adverse Event
    Injury ·DEPUY INTERNATIONAL, LTD.·Product code KWA·July 8, 2011

    Azurion 7 M12; Catalog numbers: (1) 722078, (2) 722223, (3) 722233 (OUS ONLY).

    FDA Enforcement
    Class I ·Ongoing·PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.·February 26, 2025