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

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    ORTHOPILOT NEXT GENERATION, MODEL FS101-FS106

    FDA 510(k)
    FDA Class 2 ·Neurology

    iTotal® CR Tibial Keel Punch Tip

    FDA UDI
    Conformis, Inc.·00850268007279·iTotal® CR 12mm Tibial Keel Punch Tip Reusable ...

    ATR TECNIKA

    FDA 510(k)
    FDA Class 1 ·Dental

    VERTEX SEALAND L/C ORTHODONTIC SEALANT

    FDA 510(k)
    FDA Class 2 ·Dental

    PINNACLE MTL INS NEUT36IDX54OD

    FDA Adverse Event
    Injury ·DEPUY ORTHOPAEDICS INC US·Product code KWA·April 26, 2013

    LIGHTSPEED VCT

    FDA Adverse Event
    Injury ·GE MEDICAL SYSTEMS, LLC·Product code JAK·April 22, 2011

    ACCU-CHEK COMFORT CURVE TEST STRIPS

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

    REF TIN3015, 15G x 79 mm Bone Marrow Aspiration/Intraosseous Infusion Needle, For Single Use Only, Sterile EO, UDI: 10885403043796

    FDA Enforcement
    Class II ·Ongoing·Bard Peripheral Vascular Inc·October 13, 2021

    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