BEUDAMED
    11 results · 19ms · Sources: EU EUDAMED, US FDA

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    RADIONICS XKNIFE HDRT SYSTEM

    FDA 510(k)
    FDA Class 2 ·Radiology

    Navagio

    FDA UDI
    Kalitec Direct LLC·B07330K0134140·Trial, TLIF, 27L OB STR 7Deg, 14mm

    VARELISA TG (THYROGLOBULIN) ANTIBODIES,

    FDA 510(k)
    FDA Class 2 ·Immunology

    MIDA ALGORITHM REV. B

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    STERNAL UNILOCK-SCR 3 SELF-TAP L16 5U

    FDA Adverse Event
    Malfunction ·SYNTHES MONUMENT·Product code HWC·April 29, 2013

    3.5MM LOCKING SCREW SELF-TAPPING 45MM

    FDA Adverse Event
    Injury ·SYNTHES GMBH·Product code KTT·April 29, 2011

    CAPSURE EPI

    FDA Adverse Event
    Malfunction ·MEDTRONIC, INC.·Product code DTB·July 25, 2008

    BD Connecta Stopcock Without Extension Tube Catalog No. 394600 (OUS)

    FDA Enforcement
    Class II ·Ongoing·Becton Dickinson & Company·July 27, 2022

    VesselNavigator application used with Philips Azurion (Azurion 7 Series) Software R1.2 and R2.0, and Philips Allura Xper R9, upgraded to Azurion 1.2 M20. System codes: Azurion 7 B12 (722067), Azurion 3 B20 (722068), Azurion 7 M12 (722078), Azurion 7 M20 (722079), Field Extensions Azurion 7 series (722136), Allura Xper R9 (722303). The product is software, used during an endovascular intervention procedure.

    FDA Enforcement
    Class II ·Terminated·Philips North America, LLC·February 19, 2020

    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

    Stryker MA204 Bed Model (FL25E) Beds are intended for medical purposes in both general patient care as well as critical care environments. Each uses built-in electric motors and controls which can be operated by the patient, or caregiver, to adjust the height and/or surface contour of the bed.The devices listed above also include movable and latchable side rails which can be lowered or raised to help prevent patient fall and subsequent injury. The Beds include an optional Scale (Models: FL20E, FL25E, FL28C, FL28EX) as well as an optional Bed Exit (1 Zone) or Chaperone

    FDA Enforcement
    Class II ·Terminated·Stryker Medical Division of Stryker Corporation·July 4, 2012