BEUDAMED
    10 results · 19ms · Sources: EU EUDAMED, US FDA

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    HYDROTONE I

    FDA 510(k)
    FDA Class 2 ·Physical Medicine

    Epicage Interbody Fusion System

    FDA UDI
    ALPHATEC SPINE, INC.·00840967190730·Oblique Portal – 8mm

    FORZA

    FDA UDI
    Orthofix US LLC·18257200077403·9W X 27L X 0° X 8H CURVED TRIAL

    RESTEP DVY SYSTEM, MODEL RSP-101

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    Medicom SafeMask Sofskin Pediatric Procedure Earloop Face Masks (ASTM Level 1), Medicom SafeMask Sofskin Pediatric Procedure Earloop Face Masks, Medicom SafeMask Premier Pediatric Procedure Earloop Face Masks (ASTM Level 1), Medicom SafeMask Premier Pediatric Procedure Earloop Face Masks (ASTM Level 1)

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

    MENTOR SMOOTH ROUND MODERATE PLUS PROFILE

    FDA Adverse Event
    Injury ·MENTOR TEXAS·Product code FWM·June 27, 2024

    NATURALYTE

    FDA Adverse Event
    Death ·FRESENIUS MEDICAL CARE NORTH AMERICA·Product code KPO·June 11, 2014

    OT VERIO IQ METER

    FDA Adverse Event
    Malfunction ·LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL·Product code NBW·July 5, 2015

    CAPSURE Z

    FDA Adverse Event
    Death ·MEDTRONIC PUERTO RICO, INC.·Product code DTB·November 3, 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