BEUDAMED
    62 results · 37ms · Sources: EU EUDAMED, US FDA

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    E-CLASS® DUAL MOBILITY INSERTS and DYNASTY® DUAL MOBILITY LINERS

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    Paradigm

    FDA UDI
    Proprio, Inc.·00850042604113·Paradigm General Instrument Case Tray

    ReLine

    FDA UDI
    Nuvasive, Inc.·00195377046949·RELINE-O Trial, 7mm H Lamina W L-pop

    Phasix

    FDA UDI
    Davol Inc.·00801741095283·Phasix ST Mesh, 11 cm (4.5"), Circle

    ThinPrep®

    FDA UDI
    Hologic, Inc.·15420045508361·For use with the ThinPrep® system to preserve n...

    Zavation

    FDA UDI
    Zavation LLC·00842166131590·Ti3Z CIF 12mmx14mmx11mm -0 deg

    Half Pin

    FDA UDI
    Treace Medical Concepts, Inc.·00810111221573·Half pin - micro cobalt chrome

    Treace Medical Concepts

    FDA UDI
    Provision·B504OM02000110·

    OptumSI Implant System

    FDA UDI
    SI Solutions, LLC·00850057247077·Pin Holder

    OsteoMed

    FDA UDI
    OSTEOMED LLC·00845694005630·1.0mm Pilot Drill, 4mm Stop, J-Latch

    IRIS SCISSORS

    FDA UDI
    SONTEC INSTRUMENTS, INC.·00192896083462·IRIS SCISSORS SHARP STRAIGHT BLADE POWER CUT GO...

    MicroAire®

    FDA UDI
    Microaire Surgical Instruments LLC·00847399000903·SMALL SAGITTAL SAW BLADE, 8.1mm X 6.6mm X 0.5mm

    Next Generation Sequencing Oncology Panel, Somatic Or Germline Variant Detection System

    FDA Pre-Market Approval
    FDA Class 3 ·ONCO/Reveal Dx Lung & Colon Cancer Assay (O/RDx-LCCA)

    Brilliance iCT SP Computed Tomography X-ray Systems, Intended to produce cross-sectional images of the body by computer reconstruction of X-ray transmission data taken at different angles and planes

    FDA Enforcement
    Class II ·Terminated·Philips Medical Systems (Cleveland) Inc·April 20, 2016

    MODIFIED HYDROPHILIC COATED GUIDEWIRE

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    FISHER & PAYKEL HEALTHCARE BUBBLE CPAP SYSTEM

    FDA 510(k)
    FDA Class 2 ·Anesthesiology

    Next Generation Sequencing Oncology Panel, Somatic Or Germline Variant Detection System

    FDA Pre-Market Approval
    FDA Class 3 ·ONCO/Reveal Dx Lung & Colon Cancer Assay (O/RDx-LCCA)

    Next Generation Sequencing Oncology Panel, Somatic Or Germline Variant Detection System

    FDA Pre-Market Approval
    FDA Class 3 ·oncoRevealTM CDx

    NEONATAL BUBBLE CPAP DUAL HEATED CIRCUIT KIT

    FDA Adverse Event
    Malfunction ·Product code BZE·March 3, 2021

    MPACT ACETABULAR SYSTEM

    FDA Adverse Event
    Injury ·MEDACTA INTERNATIONAL SA·Product code LPH·January 23, 2026