BEUDAMED
    19 results · 36ms · Sources: EU EUDAMED, US FDA

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    MODIFICATION TO: INSTAREAD LITHIUM SYSTEM

    FDA 510(k)
    FDA Class 2 ·Clinical Toxicology

    VITAPORT 3

    FDA 510(k)
    FDA Class 2 ·Neurology

    ARTIC SUN TEMPERATURE MANAGEMENT SYSTEM, MODEL 200

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    CART 9734056 S7 STAFF SHRT 100-120V INTL

    FDA Adverse Event
    Malfunction ·MEDTRONIC NAVIGATION, INC·Product code HAW·June 14, 2019

    CART 9733856 S7 STAFF ASSEMBLED 110V

    FDA Adverse Event
    Malfunction ·MEDTRONIC NAVIGATION, INC·Product code HAW·June 4, 2019

    NAVLOCK UNIVERSAL GREEN TRACKER

    FDA Adverse Event
    Malfunction ·MEDTRONIC NAVIGATION, INC. (LOUISVILLE)·Product code HAW·October 30, 2015

    SCREW DRIVER

    FDA Adverse Event
    Malfunction ·MEDTRONIC NAVIGATION, INC·Product code HAW·August 5, 2019

    INTERSTIM II

    FDA Adverse Event
    Injury ·MEDTRONIC MED REL MEDTRONIC PUERTO RICO·Product code EZW·April 10, 2013

    FINELINE II

    FDA Adverse Event
    Injury ·CPI - DEL CARIBE·Product code NVN·April 12, 2011

    COSGROVE-EDWARDS ANNULOPLASTY SYSTEM

    FDA Adverse Event
    Injury ·EDWARDS LIFESCIENCES·Product code KRH·May 23, 2008

    CART 9734056 S7 STAFF SHRT 100-120V INTL

    FDA Adverse Event
    Malfunction ·MEDTRONIC NAVIGATION, INC·Product code HAW·June 18, 2019

    CART 9734056 S7 STAFF SHRT 100-120V INTL

    FDA Adverse Event
    Malfunction ·MEDTRONIC NAVIGATION, INC. (LOUISVILLE)·Product code HAW·May 18, 2018

    NAV THORACIC PROBE TIP

    FDA Adverse Event
    Injury ·MEDTRONIC NAVIGATION, INC.·Product code OLO·August 27, 2014

    UNKNOWN GROSHONG TITANIUM PORT S/L

    FDA Adverse Event
    Malfunction ·C.R. BARD, INC. (BASD) -3006260740·Product code LJT·December 13, 2024

    MSS - HUMERAL REVERSE LINERS

    FDA Adverse Event
    Injury ·MEDACTA INTERNATIONAL SA·Product code PHX·February 18, 2026

    NEUROLOGICAL STEREOTAXIC INSTRUMENT

    FDA Adverse Event
    Injury ·MEDTRONIC NAVIGATION, INC. (LOUISVILLE)·Product code HAW·October 26, 2015

    Merit Medical , Custom Inflation Kit REF: K05-00761F K05-01717B K05-02080D K05-02090C K05-02221 K05-02338 K05-02470 K05-02954 K05-03094A K05T-00380C K05T-01674B K05T-01863 K05T-01915 K05T-01920F K05T-01955 K05T-02138 K05T-02138A K05T-02272G K05T-02272H K05T-02533 K05T-03153 K05T-03201

    FDA Enforcement
    Class II ·Ongoing·Merit Medical Systems, Inc.·January 28, 2026

    Merit Medical , Custom Inflation Kit REF: K05-00761F K05-01717B K05-02080D K05-02090C K05-02221 K05-02338 K05-02470 K05-02954 K05-03094A K05T-00380C K05T-01674B K05T-01863 K05T-01915 K05T-01920F K05T-01955 K05T-02138 K05T-02138A K05T-02272G K05T-02272H K05T-02533 K05T-03153 K05T-03201

    FDA Recall
    Open, Classified ·Merit Medical Systems, Inc.·Product code PPD·December 4, 2025

    Ellipse, Sterile EO, Model #/ Part #: CD1275-36/100116115; CD1275-36Q/100116116; CD1277-36/100048388, 100048391, 100060126, 100116208, 10011636; CD1277-36Q/100048374, 100048394, 100060198, 100098497, 100116268, 100116345; CD1293-36Q/100057838; CD1309-36/100057717; CD1309-36Q/100057718; CD1311-36/100057802, 100060153; CD1311-36Q/100057803, 100060174, 100116264; CD1377-36/100078796, 100079180, 100096847; CD1377-36C/100078612, 100079197, 100079368, 100116120, 100116407, 100116447; CD1377-36Q/100078747, 100079210, 100096848, 100116385, 100116423, 100116427; CD1377-36QC/100078602, 100079199, 100079229, 100116398, 100116409, 100116466,100116485, 100127151, 100127152, 100127153; CD1393-36C/100116461; CD1393-36QC/100080656, 100116339; CD1409-36Q/100080251; CD1411-36C/100080197, 100080232, 100116411, 100116481; CD1411-36Q/100080244, 100080245, 100116338, 100116464; CD1411-36QC/100116337; CD2275-36/100116355; CD2275-36Q/100116349; CD2277-36/100048359, 100048402, 100116206, 100116207; CD2277-36Q/100048377, 100048404,100060190, 100098661, 100116342, 100116350; CD2293-36/100057765; CD2293-36Q/100057766; CD2309-36/100057804; CD2309-36Q/100057763; CD2311-36/100057679, 100060100; CD2311-36Q/100057835, 100060161, 100116351; CD2377-36/100078811, 100079226, 100096774; CD2377-36C/100078601,100079225, 100079304, 100116405, 100116424, 100116484; CD2377-36Q/100078812,100079208, 100096838, 100116406, 100116414, 100116437; CD2377-36QC/100078579, 100079176, 100079352, 100116413, 100116422, 100116436, 100116482, 100127100, 100127154, 100127181; CD2393-36C/100080653, 100116416; CD2393-36QC/100080655, 100116451; CD2409-36C/100079997; CD2409-36Q/100080149; CD2411-36C/100079986, 100080104, 100116118, 100116444; CD2411-36Q/100080180, 100080230, 100116370, 100116420

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