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

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    MICRO-TOUCH NITRAFREE

    FDA 510(k)
    FDA Class 1 ·General Hospital

    iTotal® CR Tibial Tray Impactor Tip

    FDA UDI
    Conformis, Inc.·00850268007200·iTotal® CR Tibial Tray Impactor Tip Reusable In...

    SYNTHES ANTERIOR CSLP SYSTEM

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    MOXIFLOXACIN ANTIMICROBIAL SUSCEPTIBILITY TEST DISC

    FDA 510(k)
    FDA Class 2 ·Microbiology

    ISOFLEX LEAD

    FDA Adverse Event
    Death ·ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION·Product code DTB·April 26, 2013

    6F ANGIO-SEAL EVOLUTION

    FDA Adverse Event
    Injury ·ST. JUDE MEDICAL·Product code MGB·April 22, 2011

    ACCU-CHEK ACTIVE TEST STRIPS

    FDA Adverse Event
    Malfunction ·ROCHE DIAGNOSTICS·Product code LFR·July 22, 2008

    UNKNOWN

    FDA Adverse Event
    Malfunction ·COOK INC·Product code DQX·July 26, 2024

    RUNTHROUGH NS

    FDA Adverse Event
    Malfunction ·TERUMO CORPORATION, ASHITAKA·Product code DQX·January 24, 2018

    TI CERVICAL SPINE LOCKING PLATE 45MM (37MM)

    FDA Adverse Event
    Injury ·SYNTHES MONUMENT·Product code KWQ·September 9, 2015

    RUNTHROUGH NS

    FDA Adverse Event
    Injury ·TERUMO CORPORATION, ASHITAKA·Product code DQX·January 30, 2018

    Aurora Series, Aurora 7 lighthead; Models: LED7 (including TV models). The Aurora Series is intended to illuminate the surgical field and ensure visibility of the surgical site.

    FDA Enforcement
    Class II ·Ongoing·DKK Dai-Ichi Shomei Co., Ltd.·August 21, 2024

    On-Board Imager - Exact Arm Elbow Motor Shaft (kVD, kVS, and MV) with ''Type 01" elbow motors. Product Usage: The On-Board Imager device is an x-ray device used for evaluation of correct patient position in relation to isocenter and verification of treatment fields in relation to anatomical and fiducial landmarks.

    FDA Enforcement
    Class II ·Terminated·Varian Medical Systems, Inc.·April 30, 2014

    Alaris Syringe Pump, Model No. 8110. Delivers fluids. Expansion of Affected Units: BOM Housing Assembly Service, Part No. 49000226, and Lower Housing/Carriage Block Assembly, Part No. 148188-100.

    FDA Enforcement
    Class I ·Terminated·CareFusion 303, Inc.·August 26, 2015