BEUDAMED
    19 results · 25ms · Sources: EU EUDAMED, US FDA

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    Aries® Lumbar Interbodies

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    ILUMA VISION

    FDA 510(k)
    FDA Class 2 ·Radiology

    MAGNETOM AERA; MAGNETOM SKYRA

    FDA 510(k)
    FDA Class 2 ·Radiology

    OSSURE LOEP KIT

    FDA Adverse Event
    Death ·AGNOVOS HEALTHCARE USA, LLC·Product code MQV·December 27, 2018

    CARTIVA IMPLANT

    FDA Adverse Event
    Injury ·CARTIVA, INC·Product code PNW·November 13, 2020

    CARTIVA IMPLANT

    FDA Adverse Event
    Injury ·CARTIVA, INC·Product code PNW·November 9, 2020

    OSSURE LOEP KIT

    FDA Adverse Event
    Death ·AGNOVOS HEALTHCARE USA, LLC·Product code MQV·January 18, 2020

    ENTUIT GASTROSTOMY BR BALLOON RETENTION FEEDING TUBE WITH ENFIT CONNECTION

    FDA Adverse Event
    Injury ·XERIDIEM MEDICAL DEVICES·Product code PIF·April 18, 2018

    PINNACLE 300 ACET CUP 52MM

    FDA Adverse Event
    Injury ·DEPUY ORTHOPAEDICS INC US·Product code LPH·June 21, 2013

    THORATEC VENTRICULAR ASSIST DEVICE SYSTEM (DDC)

    FDA Adverse Event
    Injury ·THORATEC CORP.·Product code DSQ·July 21, 2011

    OCTRODE

    FDA Adverse Event
    Injury ·ST. JUDE MEDICAL - NEUROMODULATION·Product code GZB·August 6, 2014

    MAGNETOM Skyra (DE). Model Number: 10432915. 510(k) Numbers: K101347, K111242, K123510, K133435, K140253, K141977, K142515, K153343, K173592, K202014, K231560.

    FDA Recall
    Open, Classified ·Siemens Medical Solutions USA, Inc·Product code LNH·August 28, 2025

    ENTUIT GASTROSTOMY BR BALLOON RETENTION FEEDING TUBE WITH ENFIT CONNECTION

    FDA Adverse Event
    Malfunction ·XERIDIEM MEDICAL DEVICES·Product code PIF·April 25, 2018

    MAGNETOM Skyra (DE). Model Number: 10432915. 510(k) Numbers: K101347, K111242, K123510, K133435, K140253, K141977, K142515, K153343, K173592, K202014, K231560.

    FDA Enforcement
    Class I ·Ongoing·Siemens Medical Solutions USA, Inc·October 8, 2025

    ENTUIT GASTROSTOMY BR BALLOON RETENTION FEEDING TUBE WITH ENFIT CONNECTION

    FDA Adverse Event
    Malfunction ·XERIDIEM MEDICAL DEVICES·Product code PIF·April 25, 2018

    ENTUIT GASTROSTOMY BR BALLOON RETENTION FEEDING TUBE WITH ENFIT CONNECTION

    FDA Adverse Event
    Death ·XERIDIEM MEDICAL DEVICES·Product code PIF·April 25, 2018

    ENTUIT GASTROSTOMY BR BALLOON RETENTION FEEDING TUBE WITH ENFIT CONNECTION

    FDA Adverse Event
    Malfunction ·XERIDIEM MEDICAL DEVICES·Product code PIF·April 26, 2018

    Vantage Total Ankle System including a. Vantage Fixed-Bearing Polyethylene Liner Component (Product Line: 350-21-XX, 350-22-XX); b. Vantage Mobile-Bearing Polyethylene Liner Component (Product Line: 350-41-XX, 350-42-XX). NOTE: Information reflects Exactech recall expansion initiated on 02/07/2022.

    FDA Enforcement
    Class II ·Ongoing·Exactech, Inc.·October 13, 2021

    Reamer / Irrigator / Aspirator (RIA): RIA Drive Shafts, RIA Tube Assemblies, sterile, RIA Reamer Head, sterile (12.0mm-19.0mm); intended to clear the medullary canal of bone marrow and debris and to effectively size the medullary canal for the acceptance of an intramedullary implant or prosthesis

    FDA Enforcement
    Class II ·Terminated·Synthes, Inc.·July 22, 2015