BEUDAMED
    11 results · 18ms · Sources: EU EUDAMED, US FDA

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    SOFT TISSUE EXPANDER

    FDA 510(k)
    FDA Class 1 ·Orthopedic

    VISION HOLLOW FIBER OXYGENATOR WITH GUARDIAN COATING

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    HYPERION X9

    FDA 510(k)
    FDA Class 2 ·Radiology

    G7 OSSEOTI 3 HOLE SHELL 52MM E

    FDA Adverse Event
    Injury ·ZIMMER BIOMET, INC.·Product code LPH·March 21, 2025

    BIOLOX® DELTA, CERAMIC FEMORAL HEAD, L, ø 36/+3.5, TAPER 12/14

    FDA Adverse Event
    Injury ·ZIMMER GMBH·Product code LZO·March 31, 2025

    RENAL - DISPOSABLE

    FDA Adverse Event
    Injury ·Product code KDJ·December 13, 2010

    TENDRIL ST

    FDA Adverse Event
    Injury ·ST. JUDE MEDICAL, INC., CRMD·Product code NVN·July 9, 2014

    NONE

    FDA Adverse Event
    Other ·Product code KAP·October 6, 2006

    WAGNER CONE PROSTHESIS®, 125°

    FDA Adverse Event
    Injury ·ZIMMER GMBH·Product code LZO·February 20, 2025

    Brand Name: CLEANER BOTTLE Product Name: CLEANER BOTTLE Model/Catalog Number: EG-1000 Software Version: N/A Product Description: CLEANER bottles used with EMS AIRFLOW PROPHYLAXIS MASTER / EMS AIRFLOW ONE devices to clean the water lines. The bottle is placed on the device during cleaning. Component: YES. AIRFLOW PROPHYLAXIS MASTER and AIRFLOW PROPHYLAXIS ONE

    FDA Enforcement
    Class II ·Ongoing·Electro Medical Systems SA·May 1, 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