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

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    EC50 MICRO+ SMOKERLYZER

    FDA 510(k)
    FDA Class 2 ·Anesthesiology

    WISEBANDS SKIN CLOSURE DEVICE

    FDA 510(k)
    FDA Class 1 ·General, Plastic Surgery

    LEVEEN ELECTRODE

    FDA 510(k)
    FDA Class 2 ·General, Plastic Surgery

    2027971-2025-082315

    FDA Adverse Event
    Injury ·NOBEL BIOCARE USA, LLC·Product code DZE·July 24, 2025

    ASAHI REXEED-LX SERIES DIALYZER

    FDA Adverse Event
    Injury ·ASAHI KASEI MEDICAL CO., LTD.·Product code KDI·May 4, 2012

    RELION® INSULIN SYRINGE

    FDA Adverse Event
    Malfunction ·BD MEDICAL - DIABETES CARE·Product code FMF·October 26, 2022

    NA

    FDA Adverse Event
    Malfunction ·ARROW INTL., INC.·Product code DQO·April 16, 2013

    ATTAIN OTW

    FDA Adverse Event
    Death ·MEDTRONIC PUERTO RICO, INC.·Product code LWP·July 23, 2008

    OT ULTRALINK METER

    FDA Adverse Event
    Injury ·LIFESCAN INC.·Product code NBW·May 9, 2011

    SORIN VVR 4000I AND 4000I SMARXT FILTERED HARDSHELL VENOUS RESERVOIR

    FDA Adverse Event
    Death ·SORIN GROUP ITALIA SRL·Product code DTN·October 3, 2016

    BVI Custom Eyes¿ Ophthalmic Procedure Kits with the component -Devon Light Glove Part Number: 584569 Ophthalmic surgical kits

    FDA Enforcement
    Class II ·Terminated·Beaver-Visitec International Inc.·June 24, 2015

    Cocoon Convective Warming System, Product Code: CWS4000 (110V).

    FDA Enforcement
    Class II ·Terminated·Care Essentials Pty., Ltd.·February 12, 2020

    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