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

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    ROTECNO FR (FLUID RESISTANT) SURGICAL GOWN

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

    Polystar Selection EDITION

    FDA UDI
    Merz Dental GmbH·D7091982058·posteriors; shade B3; size L; upper jaw

    DYNAMATRIX

    FDA 510(k)
    FDA Class 2 ·Dental

    CATHETER, BETA-CAP-PERITONEAL

    FDA 510(k)
    FDA Class 2 ·Gastroenterology, Urology

    ACCU-CHEK SPIRIT COMBO

    FDA Adverse Event
    Malfunction ·ROCHE HEALTH SOLUTIONS INC.·Product code LZG·February 8, 2013

    INFANT BIAS FLOW DUAL-HEATED EVAQUA BREATHING CIRCUIT

    FDA Adverse Event
    Malfunction ·FISHER & PAYKEL HEALTHCARE LIMITED·Product code BZE·February 8, 2011

    530G INSULIN PUMP

    FDA Adverse Event
    Injury ·MEDTRONIC PUERTO RICO OPERATIONS CO.·Product code OZO·August 5, 2014

    PORTEX Bivona Tracheostomy Silicone Tube, labeled as: a) 2.5mm TTS CUFFED NEONATAL TRACHEOSTOMY TUBE , Product Code/List Number/Item Code 67SN025; b) 3.0mm TTS CUFFED NEONATAL TRACHEOSTOMY TUBE , Product Code/List Number/Item Code 67SN030; c) 3.5mm TTS CUFFED NEONATAL TRACHEOSTOMY TUBE , Product Code/List Number/Item Code 67SN035; d) 4.0mm TTS CUFFED NEONATAL TRACHEOSTOMY TUBE , Product Code/List Number/Item Code 67SN040; e) 2.5mm TTS CUFFED PEDIATRIC TRACHEOSTOMY TUBE , Product Code/List Number/Item Code 67SP025; f) 3.0mm TTS CUFFED PEDIATRIC TRACHEOSTOMY TUBE , Product Code/List Number/Item Code 67SP030; g) 3.5mm TTS CUFFED PEDIATRIC TRACHEOSTOMY TUBE , Product Code/List Number/Item Code 67SP035; h) 4.0mm TTS CUFFED PEDIATRIC TRACHEOSTOMY TUBE , Product Code/List Number/Item Code 67SP040; i) 4.5mm TTS CUFFED PEDIATRIC TRACHEOSTOMY TUBE , Product Code/List Number/Item Code 67SP045; j) 5.0mm TTS CUFFED PEDIATRIC TRACHEOSTOMY TUBE , Product Code/List Number/Item Code 67SP050; k) 5.5mm TTS CUFFED PEDIATRIC TRACHEOSTOMY TUBE , Product Code/List Number/Item Code 67SP055

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

    Exactech Equinoxe REVERSE SHOULDER,42mm Humeral Liner, a) +0mm, Item number 320-42-00, b) +2.5mm, Item Number 320-42-03; Shoulder Arthroplasty

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