BEUDAMED
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    REVISED LABELING FOR SYVA PROPOXYPHENE ASSAYS

    FDA 510(k)
    FDA Class 2 ·Clinical Toxicology

    UniTip Catheter

    FDA UDI
    Unisensor AG·07640172973431·

    VETA/VENTED ESOPHAGEAL TUBE AIRWAY

    FDA 510(k)
    FDA Class 2 ·Anesthesiology

    K.M. PRODUCTS ASPIRATOR

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

    OT VERIO IQ METER

    FDA Adverse Event
    Malfunction ·LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL·Product code NBW·June 16, 2014

    DISPOSABLE SUTURE PLACEMENT SYSTEM

    FDA Adverse Event
    Injury ·BOSTON SCIENTIFIC - MIAMI·Product code FHQ·October 19, 2010

    PAK NEEDLE KIT

    FDA Adverse Event
    Malfunction ·MEDTRONIC NAVIGATION, INC.·Product code HAW·December 14, 2012

    SPRYSTEP VECTOR KAFO, Custom made device dynamic ankle-foot orthosis (KAFO) non locking, REF #s: 17VKCUS and 17VKCUSX

    FDA Enforcement
    Class II ·Completed·Townsend Design·January 17, 2024

    PORTEX Bivona Tracheostomy Silicone Tube, labeled as: a) TTS TRACHEOSTOMY TUBE 7.0MM TIGHT TO SHAFT CUFF, Product Code/List Number/Item Code 670170; b) TTS TRACHEOSTOMY TUBE 8.0MM TIGHT TO SHAFT CUFF 1/EA, Product Code/List Number/Item Code 670180

    FDA Enforcement
    Class I ·Ongoing·Smiths Medical ASD Inc.·September 4, 2024