BEUDAMED
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    IMAGENPRO

    FDA 510(k)
    FDA Class 2 ·Radiology

    Merit Medical®

    FDA UDI
    Merit Medical Systems, Inc.·00884450482919·

    FIXATION STYLETS, MODELS 335-287 AND 335-288

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    DISPOSABLE STORAGE CAP

    FDA 510(k)
    FDA Class 2 ·Gastroenterology, Urology

    ORTHOBLAST II PUTTY, 5CC

    FDA Adverse Event
    Injury ·ISOTIS ORTHOBIOLOGICS, INC·Product code LYC·March 29, 2006

    DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM

    FDA Adverse Event
    Malfunction ·DEXCOM, INC.·Product code QBJ·March 3, 2025

    AEQ REV II GLENOID BASEPLATE DIA 25MM

    FDA Adverse Event
    Injury ·TORNIER S.A.S.·Product code PHX·July 1, 2025

    AEQUALIS REVERSED BASE PLATE TA6V LONG PEG WITH HA

    FDA Adverse Event
    Injury ·TORNIER S.A.S.·Product code KWS·March 13, 2025

    AEQ REV GLENOID BASEPLATE 29MM

    FDA Adverse Event
    Injury ·TORNIER S.A.S.·Product code KWS·March 6, 2025

    2MM DIAMOND BALL, 5.6CM

    FDA Adverse Event
    Malfunction ·THE ANSPACH EFFORT, INC.·Product code HBE·April 8, 2013

    PARADIGM REAL-TIME INSULIN INFUSION PUMP

    FDA Adverse Event
    Malfunction ·MEDTRONIC PUERTO RICO OPERATIONS MED-REL·Product code MDS·April 4, 2011

    TENDRIL ST

    FDA Adverse Event
    Injury ·ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION·Product code DTB·May 27, 2008

    AEQUALIS REVERSED MULTIDIRECTIONAL GLENOID PLATE HA

    FDA Adverse Event
    Injury ·TORNIER S.A.S.·Product code KWS·March 25, 2024

    D.4,5MM COMPRESSION SCREW L.32MM

    FDA Adverse Event
    Injury ·TORNIER S.A.S.·Product code KWS·January 7, 2025

    D.4,5MM COMPRESSION SCREW L.23MM

    FDA Adverse Event
    Injury ·TORNIER S.A.S.·Product code KWS·January 7, 2025

    AEQ REV GLENOID BASEPLATE 29MM

    FDA Adverse Event
    Injury ·TORNIER S.A.S.·Product code KWS·May 21, 2024

    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