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

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    Poseidon Ultrasound System

    FDA 510(k)
    FDA Class 2 ·Radiology

    MEGA SPINE SYSTEM

    FDA UDI
    BK MEDITECH CO.,LTD.·08809763500664·T-Wrench 3.0mm

    Needle Holder

    FDA UDI
    KATENA PRODUCTS, INC.·00841668108314·BARRAQUER NEEDLE HOLDER STRAIGHT

    LIFEPAK 12 DEFIBRILLATOR/MONITOR

    FDA 510(k)
    FDA Class 3 ·Cardiovascular

    UNIMAX SPECIMEN RETRIEVAL SYSTEM

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

    Ascend

    FDA UDI
    ALPHATEC SPINE, INC.·00190376519036·12 mm CORE ENDPLATE, LAT 16 x 35 mm 10°

    Ascend

    FDA UDI
    ALPHATEC SPINE, INC.·00190376521268·16 mm CORE ENDPLATE, BAN 16 x 35 mm 10°

    Ascend

    FDA UDI
    ALPHATEC SPINE, INC.·00190376519999·16 mm CORE ENDPLATE, LAT 16 x 35 mm 10°

    Ascend

    FDA UDI
    ALPHATEC SPINE, INC.·00190376520902·12 mm CORE ENDPLATE, BAN 16 x 35 mm 10°

    EVOLUTION® COLONIC CONTROLLED-RELEASE STENT - UNCOVERED

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

    PARADIGM REAL-TIME INSULIN INFUSION PUMP

    FDA Adverse Event
    Malfunction ·MEDTRONIC MINIMED·Product code OYC·October 10, 2014

    BARD-KUGEL

    FDA Adverse Event
    Injury ·C.R. BARD, INC.·Product code FTL·July 6, 2011

    HOMECHOICE PRO

    FDA Adverse Event
    Malfunction ·BAXTER HEALTHCARE - LARGO·Product code FKX·June 11, 2013

    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

    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