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

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    PDS, MODEL NST 40 FETAL MONITOR, RECORDER & TRANS.

    FDA 510(k)
    FDA Class 2 ·Obstetrics/Gynecology

    GC Initial™

    FDA UDI
    Gc America Inc.·J0228731501·GC Initial™ AL Inside IN-50 Curry, 20g

    UCSS® Screw Set

    FDA UDI
    MEDTRONIC SOFAMOR DANEK, INC.·00673978067971·BONE SCREW 873-150 4.0 CAN CORT LAG L 50

    N.A.

    FDA UDI
    DENTAURUM GmbH & Co.KG·J011873150000·Medium-Assortment Standard Bands, Tooth 47-46/3...

    DIRECTIONAL BOOT

    FDA 510(k)
    FDA Class 3 ·Cardiovascular

    APEX-LNK POLY ACETABULAR CUP LINERS

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    COMPREHENSIVE PT HYBRID GLEN POST REGENEREX

    FDA Adverse Event
    Injury ·ZIMMER BIOMET, INC.·Product code KWS·September 28, 2017

    SM HYBRID GLENOID BASE 4MM

    FDA Adverse Event
    Injury ·ZIMMER BIOMET, INC.·Product code KWS·September 28, 2017

    ENFILCON A / AVAIRA SPHERE

    FDA Adverse Event
    Injury ·COOPERVISION CARIBBEAN CORPORATION·Product code LPL·June 13, 2014

    COULTER® LH 750 HEMATOLOGY ANALYZER

    FDA Adverse Event
    Malfunction ·BECKMAN COULTER, INC.·Product code GKZ·October 18, 2010

    IMMERSION HYDROBATH

    FDA Adverse Event
    Malfunction ·INVACARE TAYLOR STREET·Product code ILJ·December 13, 2012

    SPRYSTEP VECTOR, Custom made device dynamic ankle-foot orthosis (AFO) , Reference numbers: 17V1030, 17V2030, 17V1031, 17V2031, 17V1032, 17V2032, 17V1033, 17V2033, 17V1035, 17V2035, 17V1036, 17V2036, 17V1037, 17V2037

    FDA Enforcement
    Class II ·Completed·Townsend Design·January 17, 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

    Allura Xper FD20; Model Numbers: (1) 722006, (2) 722012, (3) 722028; Associated 510(k)s: K102005, K130638, K130842, K133292, K141979, K162859, K161563;

    FDA Enforcement
    Class II ·Ongoing·PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.·October 8, 2025

    Allura Xper FD20; Catalog numbers: (1) 722006, (2) 722012, (3) 722028.

    FDA Enforcement
    Class I ·Ongoing·PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.·February 26, 2025