BEUDAMED
    16 results · 29ms · Sources: EU EUDAMED, US FDA

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    OSOM Mono Test; Sure Vue Signature Mono; ImmunoCard STAT Mono; Cardinal Health Mono II Rapid Test

    FDA 510(k)
    FDA Class 2 ·Immunology

    PEARLESCENT POWDER FREE NITRILE EXAMINATION GLOVE WITH ALOE VERA (YELLOW, RED, GREEN, BLACK, BLUE)

    FDA 510(k)
    FDA Class 1 ·General Hospital

    INVIROSTRIPE 3ML, 5ML, 10ML LUER LOCK SYRINGES

    FDA 510(k)
    FDA Class 2 ·General Hospital

    3005180920-2018-00833

    FDA Adverse Event
    Malfunction ·October 26, 2018

    GENERAL MIS INSTRUMENT SET

    FDA Adverse Event
    Malfunction ·MEDACTA INTERNATIONAL SA·Product code LXH·October 19, 2018

    BD PHASEAL¿ PROTECTOR P50J

    FDA Adverse Event
    Malfunction ·BECTON DICKINSON, S.A.·Product code LHI·December 31, 2018

    PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP

    FDA Adverse Event
    Malfunction ·MEDTRONIC PUERTO RICO OPERATIONS CO.·Product code OYC·October 17, 2014

    PROTIME MICROCOAGULATION SYSTEM

    FDA Adverse Event
    Malfunction ·INTERNATIONAL TECHNIDYNE CORP.·Product code GKP·July 6, 2011

    PLATYPUS BOWEL GRASPER

    FDA Adverse Event
    Malfunction ·KARL STORZ GMBH & CO. KG·Product code GCJ·June 3, 2013

    MAGNETOM Vida (DE). Model Number: 11060815. 510(k): K170396, K173617, K181433, K183254, K192924, K203443, K213693, K213805, K220425, K231560.

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

    SPYSCOPE DS II ACCESS & DELIVERY CATHETER

    FDA Adverse Event
    Malfunction ·BOSTON SCIENTIFIC CORPORATION·Product code FBN·September 30, 2020

    SPYSCOPE DS II ACCESS & DELIVERY CATHETER

    FDA Adverse Event
    Malfunction ·BOSTON SCIENTIFIC CORPORATION·Product code FBN·September 23, 2020

    DEKA MOTUS AY

    FDA Adverse Event
    Injury ·EL.EN. ELECTRONIC ENGINEERING S.P.A.·Product code GEX·February 18, 2019

    MAGNETOM Vida (DE). Model Number: 11060815. 510(k): K170396, K173617, K181433, K183254, K192924, K203443, K213693, K213805, K220425, K231560.

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

    Philips Azurion 7M20 systems with FlexArm ceiling-mounted system, Interventional Fluoroscopic X-Ray System, Model Numbers 722079 and 722224

    FDA Enforcement
    Class II ·Ongoing·PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.·September 11, 2024

    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