BEUDAMED
    23 results · 26ms · Sources: EU EUDAMED, US FDA

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    BioStamp nPoint

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    Low Bridge Support, RE

    FDA UDI
    MACROMEDICS B.V.·08719425705446·Low Bridge Support (RealEase) for lowerarms, ca...

    MEGA SPINE SYSTEM

    FDA UDI
    BK MEDITECH CO.,LTD.·08809763500978·Distractor

    Ophthalmic Cannula

    FDA UDI
    KATENA PRODUCTS, INC.·00841668108970·ARBISSER ANTERIOR CHAMBER CANNULA 27GA

    Ø3.5mm x 10mm Lateral Mass Screw with Set Screw

    FDA UDI
    XENCO MEDICAL LLC·B064XM21735101·Ø3.5mm x 10mm Lateral Mass Screw with Set Screw...

    ENDIUS TITLE 2 POLY AXIAL SPINAL SYSTEM

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    UNIMAX SPECIMEN RETRIEVAL SYSTEM

    FDA 510(k)
    FDA Class 2 ·Gastroenterology, Urology

    EVOLUTION® COLONIC CONTROLLED-RELEASE STENT - UNCOVERED

    FDA Adverse Event
    Malfunction ·COOK IRELAND LTD·Product code MQR·April 12, 2018

    SYMBIQ 3.13 DUAL CHA

    FDA Adverse Event
    Malfunction ·HOSPIRA COSTA RICA LTD.·Product code FRN·October 10, 2014

    GOLVO

    FDA Adverse Event
    Malfunction ·LIKO AB·Product code FSA·May 28, 2013

    COLLEAGUE PRE P1.7

    FDA Adverse Event
    Malfunction ·BAXTER HEALTHCARE - SINGAPORE·Product code FRN·July 23, 2011

    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

    EVOLUTION® COLONIC CONTROLLED-RELEASE STENT - UNCOVERED

    FDA Adverse Event
    Injury ·COOK IRELAND LTD·Product code MQR·August 17, 2017

    EVOLUTION BILIARY CONTROLLED-RELEASE STENT - FULLY COVERED

    FDA Adverse Event
    Malfunction ·COOK IRELAND LTD·Product code FAD·March 12, 2015

    EVOLUTION® COLONIC CONTROLLED-RELEASE STENT - UNCOVERED

    FDA Adverse Event
    Malfunction ·COOK IRELAND LTD·Product code MQR·March 15, 2018

    BD PLASTIPACK¿ SYRINGE

    FDA Adverse Event
    Malfunction ·BECTON DICKINSON IND. CIRURGICAS LTDA·Product code FMF·May 10, 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

    EVOLUTION ESOPHAGEAL CONTROLLED-RELEASE STENT - FULLY COVERED

    FDA Adverse Event
    Injury ·COOK IRELAND LTD·Product code ESW·November 12, 2014

    EVOLUTION ESOPHAGEAL CONTROLLED-RELEASE STENT - FULLY COVERED

    FDA Adverse Event
    Malfunction ·COOK IRELAND LTD·Product code ESW·November 12, 2014

    T2 STRATOSPHERE

    FDA Adverse Event
    Injury ·MEDTRONIC SOFAMOR DANEK USA, INC·Product code MQP·July 1, 2020