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

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    MASTRO PLUS BALLOON IN-DEFLATION DEVICE

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    HISTOACRYL FLEXIBLE PACK 5

    FDA Adverse Event
    Malfunction ·B.BRAUN SURGICAL SA·Product code MPN·December 3, 2019

    INVADER FACTOR II

    FDA 510(k)
    FDA Class 2 ·Hematology

    MEDTRONIC PS MEDICAL STRATA VALVE

    FDA 510(k)
    FDA Class 2 ·Neurology

    NA

    FDA Adverse Event
    Malfunction ·STRYKER SUSTAINABILITY SOLUTIONS LAKELAND·Product code NUJ·June 3, 2013

    9.5 FR D/L CATHETER

    FDA Adverse Event
    Injury ·C. R. BARD INC. (BASD)·Product code LJS·August 28, 2008

    EXCIMER LASER CORONARY ANGIOPLASTY CATHETER

    FDA Adverse Event
    Injury ·SPECTRANETICS CORPORATION·Product code LPC·June 21, 2011

    HISTOACRYL FLEXIBLE PACK 5

    FDA Adverse Event
    Malfunction ·B. BRAUN SURGICAL SA·Product code MPN·February 11, 2020

    HISTOACRYL TRANSLUCENT 10 AMP OF 0.5 ML

    FDA Adverse Event
    Injury ·B. BRAUN SURGICAL SA·Product code MPN·February 26, 2020

    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