BEUDAMED
    12 results · 29ms · Sources: EU EUDAMED, US FDA

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    SYNTHES CRANIOFACIAL PLATE AND SCREW SYSTEM

    FDA 510(k)
    FDA Class 2 ·Dental

    TruForm

    FDA UDI
    Rmo, Inc.·00885797099839·MD 1ST BI BD KT N/L UNIV 97

    ECHOTIP ULTRA ENDOSCOPIC ULTRASOUND NEEDLE

    FDA Adverse Event
    Malfunction ·COOK IRELAND LTD·Product code FCG·August 29, 2019

    INFINION CX

    FDA Adverse Event
    Injury ·BOSTON SCIENTIFIC NEUROMODULATION·Product code LGW·August 10, 2023

    SYNCHRON LX SYSTEMS MICROALBUMIN CALIBRATOR

    FDA 510(k)
    FDA Class 2 ·Clinical Chemistry

    PASCO MIC AND MIC/ID PANELS

    FDA 510(k)
    FDA Class 2 ·Microbiology

    OBTRYX SYSTEM

    FDA Adverse Event
    Injury ·BOSTON SCIENTIFIC - MARLBOROUGH·Product code FTL·April 26, 2013

    VITROS IMMUNODIAGNOSTIC PRODUCTS IPTH REAGENT

    FDA Adverse Event
    Malfunction ·ORTHO-CLINICAL DIAGNOSTICS·Product code CEW·May 6, 2011

    ULTRACISION HARMONIC SCALPEL HAND PIECE

    FDA Adverse Event
    Malfunction ·ETHICON ENDO-SURGERY, LLC.·Product code LFL·July 24, 2008

    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

    Quadra Assura MP, Sterile EO, Model #/ Part #: CD3269-40/100043177; CD3269-40Q/100043178; CD3271-40/100043130; CD3271-40Q/100043191; CD3369-40C/100080339, 100080478; CD3369-40Q/100080439, 100080476, 100105528; CD3371-40/100078814, 100079232, 100079513; CD3371-40C/100078639, 100079231, 100079478, 100105493, 100105494; CD3371-40Q/100078815,100079282, 100079479, 100138237; CD3371-40QC/100078640, 100079165, 100079506, 100079541, 100105505, 100105506, 100138173, 100138179, 100138222, 100138234; CD3387-40C/100105525; CD3387-40QC/100138158

    FDA Enforcement
    Class II ·Terminated·St Jude Medical Inc.·July 4, 2018