BEUDAMED
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    MODIFICATON TO: ZIMMER PERIARTICULAR LOCKING PLATES AND SCREWS

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    D-Fine™ Diamond Polishers for Hybrid Composites Trial Kit #06

    FDA UDI
    CLINICIAN'S CHOICE DENTAL PRODUCTS, INC.·07540172001250·Dental Burnisher

    MEDTRONIC STYLET KIT, MODELS 6282, 6293, AND 6254

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    KLINIDRAPE SURGICAL DRAPES

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

    ADVISOR VITAL SIGNS MONITOR

    FDA Adverse Event
    Malfunction ·SMITHS MEDICAL PM, INC.·Product code CCK·December 24, 2008

    NA

    FDA Adverse Event
    Injury ·BOSTON SCIENTIFIC NEUROMODULATION·Product code MHY·February 16, 2022

    ADVISOR VITAL SIGNS MONITOR

    FDA Adverse Event
    Malfunction ·SMITHS MEDICAL PM, INC·Product code DQK·April 28, 2010

    TAXUS LIBERTE PACLITAXEL-ELUTING CORONARY STENT SYSTEM

    FDA Adverse Event
    Injury ·BOSTON SCIENTIFIC - MAPLE GROVE·Product code NIQ·April 27, 2011

    ENDOWRIST ONE VESSEL SEALER INSTRUMENT

    FDA Adverse Event
    Malfunction ·INTUITIVE SURGICAL,INC.·Product code NAY·April 22, 2013

    OBT

    FDA Adverse Event
    Injury ·JOERNS HEALTHCARE, INC.·Product code INW·June 30, 2008

    BD PHOENIX¿ NMIC/ID-307

    FDA Adverse Event
    Malfunction ·BECTON DICKINSON & CO. (SPARKS)·Product code LON·September 10, 2025

    GE Healthcare Navigation Pin Transmitter (GE P/N 1004070) -Medical Systems InstaTrak Pin Transmitter

    FDA Recall
    Terminated ·GE OEC Medical Systems, Inc·Product code LLZ·February 6, 2006

    Exactech Equinoxe GLENOID,KEELED, CEMENTED,47, 50, 53 head, beta curvature, Sizes: a) Small, Item Number 314-02-12, b) Medium, Item Number 314-02-13, c) Large, Item Number 314-02-14, d) Extra Large, Item Number 314-02-15, Shoulder Arthroplasty

    FDA Enforcement
    Class II ·Ongoing·Exactech, Inc.·April 10, 2024

    Flexor Radial Access Set, Individual product is packaged in a Tyvek-film sterilizable outer pouch. The Flexor¿ Radial Hydrophilic Introducer Access Set is intended to introduce diagnostic and interventional devices In radial artery access procedures

    FDA Enforcement
    Class II ·Terminated·Cook Inc.·March 8, 2017