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

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    Ozark(tm) Cervical Plate System

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    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

    Peerless Buccal Tube

    FDA UDI
    ORMCO CORPORATION·00889989054170·PRLS 2NDMOL B/T 12DEG -10T 018 NDX UR

    CARDINAL HEALTH

    FDA UDI
    Cardinal Health 200, LLC·10885425209064·MINOR PROCEDURE TRAY

    Ophthalmic Ring

    FDA UDI
    KATENA PRODUCTS, INC.·00841668100820·FLIERINGA FIXATION RING 21MM

    SURELIFE ARM BP MONITOR-PREMIUM

    FDA Adverse Event
    Malfunction ·MHC MEDICAL PRODUCTS, LLC·Product code DXN·June 19, 2018

    GE VIVID P3 DIAGNOSTIC ULTRASOUND IMAGING SYSTEM

    FDA 510(k)
    FDA Class 2 ·Radiology

    HEARTWAY POWER MOBILITY SCOOTER, PF6

    FDA 510(k)
    FDA Class 2 ·Physical Medicine

    HEARTSTART FRX

    FDA Adverse Event
    Malfunction ·PHILIPS MEDICAL SYSTEMS·Product code MKJ·June 11, 2013

    UNICEL DXI 800 ACCESS IMMUNOASSAY SYSTEM

    FDA Adverse Event
    Malfunction ·BECKMAN COULTER, INC.·Product code JJE·June 15, 2011

    SOLETRA

    FDA Adverse Event
    Malfunction ·MEDTRONIC PUERTO RICO OPERATIONS CO.·Product code MHY·September 18, 2008

    MELODY TRANSCATHETER PULMONARY VALVE

    FDA Adverse Event
    Injury ·MEDTRONIC HEART VALVES DIVISION·Product code NPV·July 24, 2019

    C-FLEX MULTI-LENGTH URETERAL STENT SET

    FDA Adverse Event
    Malfunction ·COOK INC·Product code FAD·January 24, 2020

    PALINDROME

    FDA Adverse Event
    Injury ·COVIDIEN LLC·Product code MSD·July 18, 2024

    Merlin PCS Programmer software model 3330, used with Confirm Rx Insertable Cardiac Monitor (ICM), Model DM3500, Sterile. The firm name on the label of the ICM is St. Jude Medical Cardiac Rhythm Management Division, Sylmar, CA. - Product Usage: The Confirm Rx insertable cardiac monitor is designed to detect arrhythmias and wirelessly transmit data to the Merlin.net Patient Care Network. The Confirm Rx ICM is indicated for the monitoring and diagnostic evaluation of patients who experience unexplained symptoms such as: dizziness, palpitations, chest pain, syncope, and shortness of breath, as well as patients who are at risk for cardiac arrhythmias. It is also indicated for patients who have been previously diagnosed with atrial fibrillation or who are susceptible to developing atrial fibrillation.

    FDA Enforcement
    Class II ·Terminated·St Jude Medical, Cardiac Rhythm Management Division·January 22, 2020