BEUDAMED
    12 results · 20ms · Sources: EU EUDAMED, US FDA

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    ECHELON HIGH RESOLUTION FOOT COIL (MR-HRF-150), ECHELON LONG BONE COIL (MR-LBC-150)

    FDA 510(k)
    FDA Class 2 ·Radiology

    PERFORMAX

    FDA UDI
    Respironics, Inc.·00606959008069·PERFORMAX PEDIATRIC MASK WITH STANDARD ELBOW, M...

    WET LIGHT PERSONAL MOISTURIZER

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

    CONCENTRIC MICRO CATHETER, MODELS 90001 TO 90008

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    INTERVERTEBRAL FUSION DEVICE WITH BONE GRAFT, LUMBAR

    FDA Adverse Event
    Death ·MEDTRONIC SOFAMOR DANEK USA, INC.·Product code MAX·December 18, 2019

    SETROX S 53

    FDA Adverse Event
    Injury ·BIOTRONIK SE & CO. KG·Product code NVN·April 29, 2013

    LINOX SD 65/16

    FDA Adverse Event
    Other ·BIOTRONIK SE & CO. KG·Product code LWS·April 29, 2011

    OXIMAX N-595 PULSE OXIMETER

    FDA Adverse Event
    Malfunction ·COVIDIEN, FORMERLY TYCO HEALTHCARE·Product code DQA·July 23, 2008

    Z NAIL CMF 10.5 X 100 LAG SCR

    FDA Adverse Event
    Injury ·ZIMMER SWITZERLAND MANUFACTURING GMBH·Product code HSB·August 18, 2023

    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

    OEC 6800 Miniview, Image-intensified fluoroscopic x-ray system used during diagnostic, surgical and interventional procedures. Designed to provide the physician with general fluoroscopic visualization of the patient including but not limited to surgical orthopedic and extremity imagine. The device is not intended for whole-body pediatric imaging.

    FDA Enforcement
    Class I ·Terminated·GE OEC Medical Systems, Inc·August 1, 2012