BEUDAMED
    17 results · 20ms · Sources: EU EUDAMED, US FDA

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    6MP COLOR LCD MONITOR, RADIFORCE RX650

    FDA 510(k)
    FDA Class 2 ·Radiology

    EVONOS

    FDA UDI
    Gyrus ACMI, LLC·00821925012387·VOCOM VOCAL CORD MEDIALIZATION TRIAL 5 MM DISPL...

    Antiserum to Human C Reactive Protein

    FDA UDI
    KENT LABORATORIES INC·B1761340·goat antiserum to human C Reactive Protein

    N/A

    FDA UDI
    Ortho Development Corporation·00822409116676·Neck Trial, STD, Size 4-5

    ALEUTIAN Interbody Systems

    FDA UDI
    VB Spine LLC·10888857563148·Disc Scraper Size 5 mm

    GAMMA3 NAIL SYSTEM

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    VERIFICATION CONSOLE

    FDA 510(k)
    FDA Class 2 ·Radiology

    SLIDE RASP HANDLE

    FDA Adverse Event
    Malfunction ·STRYKER SPINE-FRANCE·Product code LXH·January 8, 2016

    SLIDE RASP HANDLE

    FDA Adverse Event
    Malfunction ·STRYKER SPINE-FRANCE·Product code LXH·November 4, 2016

    EarlySense® InSight™

    FDA UDI
    EARLYSENSE LTD·07290016169102·

    OT VERIO IQ METER

    FDA Adverse Event
    Malfunction ·LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL·Product code NBW·October 2, 2014

    AEQUALIS

    FDA Adverse Event
    Injury ·TORNIER SAS·Product code KWS·May 23, 2013

    CARELINK

    FDA Adverse Event
    Malfunction ·PLEXUS MANUFACTURING SDN. BHD.·Product code NVZ·June 20, 2011

    PENTAX

    FDA Adverse Event
    Malfunction ·HOYA CORPORATION PENTAX TOKYO OFFICE·Product code FDF·July 21, 2021

    The device is a whole-body CT x-ray system. The acquired x-ray transmission data is reconstructed by computer into cross-sectional images of the body taken at different angles and planes. The system also includes signal analysis and display equipment, patient and equipment supports, components, and accessories. Philips Inclusive CT has a 72cm bore and includes a detector array that provides 50cm scan field of view.

    FDA Enforcement
    Class II ·Completed·Philips North America Llc·December 27, 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

    Exactech Equinoxe CAGE GLENOID, CEMENTED, alpha curvature, Mates with: a) 38, 41, 44 head, Small, Item Number 314-13-02, b) 38, 41, 44 head, Medium, Item Number 314-13-03, c) 38, 41, 44 head, Large, Item Number 314-13-04; Shoulder Arthroplasty

    FDA Enforcement
    Class II ·Ongoing·Exactech, Inc.·April 10, 2024