BEUDAMED
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    STERILE DISP. INSTRUMENT TRAYS

    FDA 510(k)
    FDA Class 1 ·General, Plastic Surgery

    KIMBERLY-CLARK LAVENDER NITRILE POWDER-FREE EXAM GLOVE

    FDA 510(k)
    FDA Class 1 ·General Hospital

    SPACER G TEMPORARY HIP PROSTHESIS

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    UNIVERSAL MODULAR ELECTRIC/BATTERY DOUBLE

    FDA Adverse Event
    Malfunction ·ZIMMER SURGICAL S.A·Product code GEY·March 6, 2014

    EON MINI

    FDA Adverse Event
    Injury ·ST. JUDE MEDICAL - NEUROMODULATION·Product code LGW·November 9, 2012

    SPINAL CORD STIMULATION

    FDA Adverse Event
    Malfunction ·MEDTRONIC NEUROMODULATION·Product code LGW·September 8, 2010

    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

    Azurion 7 M12; Catalog numbers: (1) 722078, (2) 722223, (3) 722233 (OUS ONLY).

    FDA Enforcement
    Class I ·Ongoing·PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.·February 26, 2025