BEUDAMED
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    CLINITEK NOVUS; AUTOMATED URINE CHEMISTRY ANALYZER, 10 URINALYSIS CASSETTE, CALIBRATION KIT

    FDA 510(k)
    FDA Class 1 ·Clinical Chemistry

    KONICA MINOLTA XPRESS DIGITAL MAMMOGRAPHY SYSTEM

    FDA 510(k)
    FDA Class 2 ·Radiology

    NUNC IVF MULTIDISH 4 WELLS NUNCLON

    FDA 510(k)
    FDA Class 2 ·Obstetrics/Gynecology

    ARCTIC FRONT ADVANCE CARDIAC CRYOABLATION CATHETER

    FDA Adverse Event
    Malfunction ·MEDTRONIC CRYOCATH LP·Product code OAE·October 3, 2014

    TREK CORONARY DILATATION CATHETER

    FDA Adverse Event
    Malfunction ·AV-TEMECULA-CT·Product code LOX·May 31, 2013

    ALARIS PCA MODULE ADMINISTRATION SET

    FDA Adverse Event
    Malfunction ·CAREFUSION CORPORATION·Product code FPA·June 15, 2011

    VENTED AUTOFEED CHAMBER

    FDA Adverse Event
    Malfunction ·FISHER & PAYKEL HEALTHCARE LTD·Product code BTT·January 8, 2015

    CABLE TENSIONER

    FDA Adverse Event
    Malfunction ·SYNTHES MONUMENT·Product code LXH·August 27, 2013

    HOLLOW FIBER OXYGENATOR

    FDA Adverse Event
    Malfunction ·TERUMO CORPORATION, ASHITAKA·Product code DTZ·December 12, 2014

    Subcutaneous Implantable Cardioverter Defibrillator (S-ICD) System, labeled as EMBLEM MRI S-ICD Pulse Generator

    FDA Enforcement
    Class II ·Ongoing·Boston Scientific Corporation·September 25, 2019

    Various products which were contract sterilized.

    FDA Enforcement
    Class II ·Ongoing·Anewmed Corporation·November 6, 2019

    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