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

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    STRATA BURR HOLE VALVE, MODEL 42836 AND STRATA BURR HOLE SHUNT ASSEMBLY, MODEL 46836

    FDA 510(k)
    FDA Class 2 ·Neurology

    SELF CURING DENTURE POWDER

    FDA UDI
    LANG DENTAL MANUFACTURING CO., INC.·D6500830760·AUTOPOLYMERIZING DENTURE ACRYLIC RESIN POWDER

    SYNCHRON VANCOMYCIN REAGENT

    FDA Adverse Event
    BECKMAN COULTER INC.·Product code LEH·June 10, 2011

    SYNCHRON SYSTEMS VANCOMYCIN REAGENT; SYNCHRON SYSTEMS VANCOMYCIN CALIBRATOR

    FDA 510(k)
    FDA Class 2 ·Clinical Toxicology

    MITEK CUFFTACK

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    NANOKNIFE SYSTEM

    FDA Adverse Event
    Injury ·ANGIODYNAMICS·Product code OAB·June 9, 2015

    INTERVERTEBRAL FUSION DEVICE WITH BONE GRAFT, LUMBAR

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

    SYNOX SX 53/15-BP

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

    HEART START XL

    FDA Adverse Event
    Malfunction ·PHILIPS HEALTHCARE·Product code MKJ·March 31, 2011

    PHASEAL INFUSION ADAPTER

    FDA Adverse Event
    Malfunction ·CARMEL PHARMA AB.·Product code FPA·July 23, 2008

    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