BEUDAMED
    19 results · 22ms · Sources: EU EUDAMED, US FDA

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    DIGNITY 100

    FDA 510(k)
    FDA Class 1 ·Physical Medicine

    MODIFICATION TO SYMPHONY GRAFT DELIVERY SYSTEM

    FDA 510(k)
    FDA Class 2 ·General Hospital

    MODIFICATION TO MULTITRANS CULTURE COLLECTION AND TRANSPORT SYSTEM

    FDA 510(k)
    FDA Class 1 ·Microbiology

    RETRACTOR HANDLE

    FDA Adverse Event
    Malfunction ·SYNTHES HAGENDORF·Product code GAD·June 3, 2015

    INTERSTIM II

    FDA Adverse Event
    Malfunction ·MEDTRONIC MED REL MEDTRONIC PUERTO RICO·Product code EZW·April 29, 2013

    ONETOUCHPING GLUCOSEMGMTSYSTEM

    FDA Adverse Event
    Malfunction ·ANIMAS CORPORATION·Product code LZG·May 9, 2011

    FREESTYLE FREEDOM

    FDA Adverse Event
    Injury ·ABBOTT DIABETES CARE INC, USA·Product code LFR·July 23, 2008

    ISODUR PROSTHESIS HEAD 12/14 32MM XL

    FDA Adverse Event
    Malfunction ·AESCULAP AG AND CO KG·Product code LPH·March 28, 2014

    AVAN TAP CORT SCR SS 4.5X26MM

    FDA Adverse Event
    Injury ·BIOMET UK LTD.·Product code LZO·December 29, 2025

    AVAN TAP CORT SCR SS 4.5X58MM

    FDA Adverse Event
    Injury ·BIOMET UK LTD.·Product code LZO·December 29, 2025

    AVAN TAP CORT SCR SS 4.5X48MM

    FDA Adverse Event
    Injury ·BIOMET UK LTD.·Product code LZO·December 29, 2025

    AVAN TAP CORT SCR SS 4.5X56MM

    FDA Adverse Event
    Injury ·BIOMET UK LTD.·Product code LZO·December 29, 2025

    AVAN TAP CORT SCR SS 4.5X60MM

    FDA Adverse Event
    Injury ·BIOMET UK LTD.·Product code LZO·December 29, 2025

    AVAN TAP CORT SCR SS 4.5X20MM

    FDA Adverse Event
    Injury ·BIOMET UK LTD.·Product code LZO·December 29, 2025

    AVAN TAP CORT SCR SS 4.5X52MM

    FDA Adverse Event
    Injury ·BIOMET UK LTD.·Product code LZO·December 29, 2025

    M2A ACETABULAR COMPONENT

    FDA Adverse Event
    Injury ·ZIMMER BIOMET, INC.·Product code KWA·May 23, 2018

    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

    Alaris Syringe Pump, Model No. 8110. Delivers fluids. Expansion of Affected Units: BOM Housing Assembly Service, Part No. 49000226, and Lower Housing/Carriage Block Assembly, Part No. 148188-100.

    FDA Enforcement
    Class I ·Terminated·CareFusion 303, Inc.·August 26, 2015

    Promote Quadra, Sterile EO, Model # / Part #: CD3221-36/100025054, 60019195; CD3223-36P/100013763; CD3239-40/100029115, 100029254, 100037181; CD3239-40Q/100029116, 100029244, 100037115

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