BEUDAMED
    14 results · 25ms · Sources: EU EUDAMED, US FDA

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    ACR LAB Urine Analysis Test System

    FDA 510(k)
    FDA Class 2 ·Clinical Chemistry

    ABDOMINAL TOURNIQUET SYSTEM

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    HAV-LOK BUNION CORRECTION SYSTEM

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    EKOSONIC ENDOVASCULAR DEVICE, 135X12CM

    FDA Adverse Event
    Malfunction ·BOSTON SCIENTIFIC CORPORATION·Product code KRA·February 3, 2023

    EKOSONIC ENDOVASCULAR DEVICE, 135X12CM

    FDA Adverse Event
    Death ·BOSTON SCIENTIFIC CORPORATION·Product code KRA·February 3, 2023

    DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM

    FDA Adverse Event
    Malfunction ·DEXCOM, INC.·Product code QBJ·July 14, 2025

    EKOSONIC ENDOVASCULAR DEVICE, 106X12CM

    FDA Adverse Event
    Malfunction ·BOSTON SCIENTIFIC CORPORATION·Product code KRA·March 1, 2023

    EKOSONIC KIT 106CM 12CM TZ

    FDA Adverse Event
    Malfunction ·BOSTON SCIENTIFIC CORPORATION·Product code KRA·December 14, 2021

    ACCU-CHEK ® AVIVA TEST STRIPS

    FDA Adverse Event
    Malfunction ·ROCHE DIAGNOSTICS·Product code LFR·July 28, 2011

    HEARTSTART MRX

    FDA Adverse Event
    Malfunction ·PHILIPS MEDICAL SYSTEMS·Product code MKJ·June 10, 2013

    HTO PLATE SCREW 6.5 X 4.5MM CANCELLOUS TITANIUM

    FDA Adverse Event
    Other ·ARTHREX, INC.·Product code HRS·September 30, 2008

    EKOSONIC ENDOVASCULAR DEVICE, 106X18CM

    FDA Adverse Event
    Injury ·BOSTON SCIENTIFIC CORPORATION·Product code KRA·May 3, 2022

    EKOSONIC ENDOVASCULAR DEVICE, 106X18CM

    FDA Adverse Event
    Death ·BOSTON SCIENTIFIC CORPORATION·Product code KRA·February 3, 2023

    Stryker T2 Arthrodesis Nailing System. Manufacturer: Stryker Trauma GmbH, Professor-Kuntscher-Str. 1-5, 24232 Schonkirchen Germany. Distributed in the USA by Stryker Orthopaedics, 325 Corporate Drive, Mahwah, NJ 07430. The T2 Arthrodesis Nail is intended for the treatment of Knee Arthrodesis. The design of the T2 Arthrodesis Nail features a unique curvature which incorporates both femur ante curvature and knee valgus bend. Indications: Aseptic failed total knee arthro-plasty with or without bone loss; Failed external fixation, non unions and malunions; Periarticular fractures where repair is not possible; Pathologic fractures and tumor resections; Pseudoarthrosis and correct osteotomy; Ipsilateral femur fractures; and Open and closed femoral fractures.

    FDA Enforcement
    Class II ·Terminated·Stryker Howmedica Osteonics Corp.·July 25, 2012