BEUDAMED
    9 results · 20ms · Sources: EU EUDAMED, US FDA

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    VersaTap™ Suture Anchor (ADP050); VersaPEEK™ Suture Anchor (APP002); MicroTi™ Suture Anchor (ATP003-M); VersaLat™ Ti Suture Anchor (ADP021-TI); VersaLat™ Suture Anchor (ADP021-PK)

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    VERSATAP SUTURE ANCHOR

    FDA Adverse Event
    Malfunction ·ORTHO-DESIGN·Product code MBI·September 15, 2025

    Shiley Adult Flexible Tracheostomy Tube Cuffless, Disposable Inner Cannula; Shiley Adult Flexible Tracheostomy Tube with TaperGuard Cuff, Disposable Inner Cannula

    FDA 510(k)
    FDA Class 2 ·Anesthesiology

    BIOMARC PRELOADED TISSUE MARKER DEVICE

    FDA 510(k)
    FDA Class 2 ·General, Plastic Surgery

    ALARIS SYSTEM

    FDA Adverse Event
    Malfunction ·CAREFUSION SD·Product code FRN·November 2, 2023

    ACCESS® 2 IMMUNOASSAY SYSTEM

    FDA Adverse Event
    Malfunction ·BECKMAN COULTER INC.·Product code JJE·September 10, 2011

    MECHANICAL (MANUAL) WHEELCHAIR

    FDA Adverse Event
    JUMAO HEALTHCARE EQUIPMENT·Product code IOR·November 11, 2014

    S-ROM*HEAD FEMORAL COCR 28+12

    FDA Adverse Event
    Injury ·9616671 DEPUY (IRELAND)·Product code JDI·July 23, 2013

    Reamer / Irrigator / Aspirator (RIA): RIA Drive Shafts, RIA Tube Assemblies, sterile, RIA Reamer Head, sterile (12.0mm-19.0mm); intended to clear the medullary canal of bone marrow and debris and to effectively size the medullary canal for the acceptance of an intramedullary implant or prosthesis

    FDA Enforcement
    Class II ·Terminated·Synthes, Inc.·July 22, 2015