BEUDAMED
    13 results · 25ms · Sources: EU EUDAMED, US FDA

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    EMS PIEZON 707 BIK AND PIEZON 707 BIK LED

    FDA 510(k)
    FDA Class 2 ·Dental

    GSO ACP1 ANTERIOR CERVICAL PLATE SYSTEM

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    MODIFICATION TO SELF-DRILLING RADIOGRAPHIC MARKERS

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

    OXF UNI TIB TRAY SZA RM/LL PMA

    FDA Adverse Event
    Injury ·BIOMET UK LTD.·Product code NRA·November 25, 2019

    OXF ANAT BRG RT SM SIZE 4 PMA

    FDA Adverse Event
    Injury ·BIOMET UK LTD.·Product code NRA·November 25, 2019

    PROMUS EVEROLIMUS ELUTING CORONARY STENT SYSTEM

    FDA Adverse Event
    Death ·AV-TEMECULA-CT·Product code NIQ·June 3, 2013

    EON 16-CHANNEL RECHARGEABLE IPG

    FDA Adverse Event
    Injury ·ST. JUDE MEDICAL - NEUROMODULATION·Product code LGW·June 21, 2011

    GE OEC 6600

    FDA Adverse Event
    Malfunction ·GE OEC MEDICAL SYSTEMS INC.·Product code JAA·September 3, 2008

    TOTAL KNEE REPLACEMENT

    FDA Adverse Event
    Malfunction ·STANMORE IMPLANTS WORLDWIDE LTD·Product code KRO·November 10, 2016

    PATIENT SPECIFIC TOTAL FEMUR

    FDA Adverse Event
    Injury ·STANMORE IMPLANTS WORLDWIDE·Product code KRO·August 15, 2018

    MOSAIC AORTIC BIOPROSTHETIC HEART VALVE

    FDA Adverse Event
    Death ·MEDTRONIC HEART VALVES DIVISION·Product code LWR·March 25, 2015

    C-Series High Energy Linear Accelerator - Models: Novalis Tx, Trilogy, Trilogy Tx, Clinac iX, Clinac 2100 C/D, Clinac 2300C/D, Clinac 21EX, Clinac 23EX with versions 7, 8, 9 and 6 MV configuration and maximum dose rate of at least 6000 MU/min only. Varian High Energy Linear Accelerator is intended to provide sterotactic radiosurgery and precision radio-therapy for lesions, tumors and conditions anywhere in the body when radiation treatment is indicated.

    FDA Enforcement
    Class II ·Terminated·Varian Medical Systems, Inc.·September 24, 2014

    C-Series: Clinac, Trilogy, Trilogy Tx. , Novalis high energy linear accelerators and UNIQUE single energy linear accelerator; Versions 7, 8 and 9. The UNIQUE is not sold in the US. Product Usage: The Varian High Energy Linear Accelerator is indicated for stereotactic radiosurgery and precision radiotherapy for lesions, tumors and conditions anywhere in the body when radiation treatment is indicated. The UNIQUE is a single energy medical linear accelerator. UNIQUE is indicated for precision radiotherapy for lesions, tumors and conditions anywhere in the body where radiation treatment is indicated.

    FDA Enforcement
    Class II ·Terminated·Varian Medical Systems, Inc.·December 11, 2013