BEUDAMED
    14 results · 28ms · Sources: EU EUDAMED, US FDA

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    VITEK IMMUNODIAGNOSTIC ASSAY SYSTEM

    FDA 510(k)
    FDA Class 2 ·Clinical Chemistry

    Symmetry Surgical®

    FDA UDI
    ASPEN SURGICAL PRODUCTS, INC.·00887482087817·Rapidclean® Grasper, Traumatic, Insert, Handle,...

    DeRoyal

    FDA UDI
    DEROYAL INDUSTRIES, INC.·00749756022255·KODEL SLING

    Novo Surgical

    FDA UDI
    NOVO SURGICAL, INC.·G5869213020·burr cleaning brushes, designed for cleaning bu...

    BIOMET MICROFIXATION STERNAL CLOSURE SYSTEM

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    Recon Steerable Sheath

    FDA 510(k)
    FDA Class 2 ·Ear, Nose, Throat

    Gibco CTS OpTmizer T Cell Expansion Serum Free Medium, bag format, Model Numbers A1048503 and A1022103. Tissue and cell culture medium.

    FDA Enforcement
    Class II ·Terminated·Life Technologies, Corp.·August 1, 2018

    UMBILICAL CATHETER

    FDA Adverse Event
    Malfunction ·VYGON·Product code FOS·February 17, 2021

    TRILOGY 100

    FDA Adverse Event
    Malfunction ·RESPIRONICS INC.·Product code CBK·May 21, 2014

    ORTHO SUMMIT SAMPLE HANDLING SYSTEM

    FDA Adverse Event
    Malfunction ·HAMILTON BONADUZ AG·Product code JTC·December 13, 2010

    PRECISION®

    FDA Adverse Event
    Malfunction ·BOSTON SCIENTIFIC NEUROMODULATION·Product code LGW·January 17, 2013

    LIGACLIP ENDOSCOPIC ROTATING MCA

    FDA Adverse Event
    Malfunction ·ETHICON ENDO-SURGERY, LLC.·Product code FZP·June 6, 2017

    I.T.S. LRS (Locking Reconstruction System) with the below descriptions and corresponding article numbers. 1. DFL (Distal Femur Locking) Distal Femur Plate; Article Numbers: 21301-5, 21301-7, 21301-9, 21301-13, 21302-5, 21302-7, 21302-9, 21302-13. 2. PTL (Proximal Lateral Tibia Locking) Proximal Lateral Tibia Plate; Article Numbers: 21321-7, 21321-12, 21322-7, 21322-12. 3.PTL (Proximal Lateral Tibia Locking) Proximal Medial Tibia Plate; Article Numbers: 21325-4, 21325-7.

    FDA Enforcement
    Class II ·Ongoing·I.T.S. GmbH·April 1, 2026

    I.T.S. LRS (Locking Reconstruction System) with the below descriptions and corresponding article numbers. 1. DFL (Distal Femur Locking) Distal Femur Plate; Article Numbers: 21301-5, 21301-7, 21301-9, 21301-13, 21302-5, 21302-7, 21302-9, 21302-13. 2. PTL (Proximal Lateral Tibia Locking) Proximal Lateral Tibia Plate; Article Numbers: 21321-7, 21321-12, 21322-7, 21322-12. 3.PTL (Proximal Lateral Tibia Locking) Proximal Medial Tibia Plate; Article Numbers: 21325-4, 21325-7.

    FDA Recall
    Open, Classified ·I.T.S. GmbH Autal 28 Lasnitzhohe Austria·Product code HRS·January 23, 2026