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

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    RESTORELLE Y CONTOUR MESH

    FDA 510(k)
    FDA Class 2 ·General, Plastic Surgery

    GYRUS ACMI, INC

    FDA UDI
    Gyrus ACMI, LLC·00821925017535·SCHUKNECHT FLUOROPLASTIC-WIRE MALLEUS ATTACHMEN...

    OsteoMed

    FDA UDI
    OSTEOMED LLC·00845694049283·2.0mm 5 Hole Offset Curved Lozenge Reduction Plate

    Accent Buccal Tube

    FDA UDI
    ORMCO CORPORATION·00889989053708·ORTHOS ACCENT UFS 15SGL NDX -10TX18 R

    OsteoMed

    FDA UDI
    OSTEOMED LLC·00845694064620·2.0 System 5 Hole Offset Lozenge Curved Plate S...

    HAWK INTRAORAL CAMERA AND ACCESSORIES

    FDA 510(k)
    FDA Class 1 ·Dental

    LASERTOUCHONE (OTC)

    FDA 510(k)
    FDA Class 2 ·Neurology

    Widex

    FDA UDI
    Widex A/S·05706069884579·WIDEX MOMENT MRR2D (Dark cherry ) 440, RC coil,...

    Widex

    FDA UDI
    Widex A/S·05706069972283·WIDEX MOMENT MBB2 440 (Dark cherry)

    Widex

    FDA UDI
    Widex A/S·05706069923483·WIDEX MOMENT MBB3D 440 (Dark cherry)

    ALTRUA

    FDA Adverse Event
    Malfunction ·GUIDANT CRM CLONMEL IRELAND·Product code LWP·October 3, 2014

    AED PRO

    FDA Adverse Event
    Death ·ZOLL MEDICAL CORPORATION·Product code MKJ·May 21, 2013

    UNICEL® DXH 800 COULTER® CELLULAR ANALYSIS SYSTEM

    FDA Adverse Event
    Malfunction ·BECKMAN COULTER, INC.·Product code GKZ·June 25, 2011

    ZENITH ALPHA THORACIC ENDOVASCULAR GRAFT PROXIMAL COMPONENTS

    FDA Adverse Event
    Malfunction ·WILLIAM COOK EUROPE·Product code MIH·August 25, 2020

    BD MAX¿ ENTERIC BACTERIAL PANEL

    FDA Adverse Event
    Malfunction ·GENEOHM SCIENCES CANADA, INC. (BD DIAGNOSTICS)·Product code PCI·October 12, 2023

    ZENITH ALPHA¿ THORACIC ENDOVASCULAR GRAFT PROXIMAL TAPERED COMPONENTS

    FDA Adverse Event
    Death ·WILLIAM COOK EUROPE·Product code MIH·October 5, 2022

    ARCHITECT C4000 ANALYZER

    FDA Adverse Event
    Malfunction ·ABBOTT MANUFACTURING INC·Product code JGS·July 14, 2014

    C-Series: Clinac, Trilogy, Trilogy Tx. , Novalis high energy linear accelerators and UNIQUE single energy linear accelerator; Versions 7, 8 and 9. The UNIQUE is not sold in the US. Product Usage: The Varian High Energy Linear Accelerator is indicated for stereotactic radiosurgery and precision radiotherapy for lesions, tumors and conditions anywhere in the body when radiation treatment is indicated. The UNIQUE is a single energy medical linear accelerator. UNIQUE is indicated for precision radiotherapy for lesions, tumors and conditions anywhere in the body where radiation treatment is indicated.

    FDA Enforcement
    Class II ·Terminated·Varian Medical Systems, Inc.·December 11, 2013

    Varian High Energy Clinacs, High Energy Accelerator, Radiation Treatment System, Model Numbers: H14, H27, H29, HCX. Product Usage: The Varian High Energy Accelerator is intended to provide stereotactic radiosurgery and precision radiotherapy for lesions, tumors and conditions anywhere in the body when radiation treatment is indicated.

    FDA Enforcement
    Class II ·Terminated·Varian Medical Systems, Inc. Oncology Systems·May 22, 2013