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

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    GORE INTRODUCER SHEATH WITH SILICONE PINCH VALVE

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    NICHOLS ADVANTAGE CHEMILUMINESCENCE HELICOBACTOR PYLORI IGG ANTIBODIES IMMUNOASSAY

    FDA 510(k)
    FDA Class 1 ·Microbiology

    NATURAL-KNEE II PATELLOFEMORAL JOINT PROSTHESIS

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    LINEAR ST

    FDA Adverse Event
    Injury ·BOSTON SCIENTIFIC NEUROMODULATION·Product code LGW·January 7, 2021

    UNKNOWN

    FDA Adverse Event
    Malfunction ·COOK INC·Product code DQX·July 26, 2024

    2.7MM/3.5MM LCP LATERAL DISTALFIBULA PLATE 4H/RIGHT/86MM

    FDA Adverse Event
    Injury ·SYNTHES ELMIRA·Product code HRS·April 29, 2013

    ROTATING MULTIPLE CLIP APPLIER

    FDA Adverse Event
    Malfunction ·ETHICON ENDO-SURGERY, LLC.·Product code FZP·May 9, 2011

    LIGASURE ADVANCE

    FDA Adverse Event
    Malfunction ·COVIDIEN LP (VALLEYLAB)·Product code GEI·July 24, 2008

    NEEDLE CLIPPING DEVICE SAFE CLIP

    FDA Adverse Event
    Malfunction ·BECTON DICKINSON·Product code FMI·July 30, 2019

    HONEYWELL - KAZ TOP FILL WARM MIST HUMIDIFIER MODEL HWM-340WWMT INTERTEC 3082356

    FDA Adverse Event
    Other ·KAZ·Product code KFZ·December 12, 2014

    Allura Xper FD20 Product Codes: (1)722012, (2) 722028, (3) 722006; Associated 510(k) numbers: K102005, K130842, K130638, K133292, K141979, K161563, K162859, K033737, K041949;

    FDA Enforcement
    Class II ·Ongoing·PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.·October 1, 2025

    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