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

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    Accula RSV Test

    FDA 510(k)
    FDA Class 2 ·Microbiology

    X12 STERILE REFLECTIVE MARKER SPHERE

    FDA 510(k)
    FDA Class 2 ·Neurology

    MENICON Z RIGID GAS PERMEABLE CONTACT LENS

    FDA 510(k)
    FDA Class 2 ·Ophthalmic

    SURESCAN

    FDA Adverse Event
    Malfunction ·MEDTRONIC PUERTO RICO OPERATIONS CO.·Product code LGW·January 29, 2018

    DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM

    FDA Adverse Event
    Malfunction ·DEXCOM, INC.·Product code QBJ·July 11, 2025

    SUNQUEST BLOOD BANK AND BLOOD DONOR

    FDA Adverse Event
    Malfunction ·SUNQUEST INFORMATION SYSTEMS·Product code MMH·October 1, 2008

    LAMITRODE TRIPOLE 16 LEAD, 60 CM

    FDA Adverse Event
    Malfunction ·ST. JUDE MEDICAL - NEUROMODULATION·Product code LGW·July 5, 2011

    ENDOPATH** DEXTRUS* SEAL CAP

    FDA Adverse Event
    Malfunction ·ETHICON ENDO-SURGERY, LLC.·Product code GCJ·June 21, 2013

    INNOVA IGS 530

    FDA Adverse Event
    Injury ·GE MEDICAL SYSTEMS SCS·Product code OWB·August 2, 2019

    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

    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

    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