BEUDAMED
    9 results · 21ms · Sources: EU EUDAMED, US FDA

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    Navi e/Navi s/Navi X Diagnostic Ultrasound System

    FDA 510(k)
    FDA Class 2 ·Radiology

    Nucleus

    FDA UDI
    COCHLEAR LIMITED·09321502027847·FREEDOM SNUGFIT EXTRA LARGE BLK

    STAR ST AND ARRHYTHMIA SOFTWARE, RELEASE J.0

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    PDM, VILET, VILET QUICK, MONO Q, PLAIN GUT:# 6 CHROMIC GUT

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

    INTERSTIM II

    FDA Adverse Event
    Malfunction ·MEDTRONIC MED REL MEDTRONIC PUERTO RICO·Product code EZW·June 20, 2013

    COLLEAGUE PRE P1.7

    FDA Adverse Event
    Malfunction ·BAXTER HEALTHCARE - SINGAPORE·Product code FRN·July 27, 2011

    STARCLOSE VASCULAR CLOSURE SYSTEM

    FDA Adverse Event
    Injury ·ABBOTT VASCULAR REDWOOD CITY·Product code MGB·September 26, 2008

    Medtronic MiniMed(TM) Quick-set(TM) (MMT-394, 394T, 399, 399T, 387, 387T, 398, 398T, 397, 397T, 386, 386T, 396, 396T)

    FDA Enforcement
    Class II ·Ongoing·Medtronic Inc.·November 29, 2017

    PORTEX Bivona Tracheostomy Silicone Tube, labeled as: a) 2.5 UNCUFFED NEONATAL TRACHEOSTOMY TUBE , Product Code/List Number/Item Code 60SN025; b) 3.0 UNCUFFED NEONATAL TRACHEOSTOMY TUBE , Product Code/List Number/Item Code 60SN030; c) 3.5 UNCUFFED NEONATAL TRACHEOSTOMY TUBE , Product Code/List Number/Item Code 60SN035; d) 4.0 UNCUFFED NEONATAL TRACHEOSTOMY TUBE , Product Code/List Number/Item Code 60SN040; e) 2.5 UNCUFFED PEDIATRIC TRACHEOSTOMY TUBE , Product Code/List Number/Item Code 60SP025; f) 3.0 UNCUFFED PEDIATRIC TRACHEOSTOMY TUBE , Product Code/List Number/Item Code 60SP030; g) 3.5 UNCUFFED PEDIATRIC TRACHEOSTOMY TUBE , Product Code/List Number/Item Code 60SP035; h) 4.0 UNCUFFED PEDIATRIC TRACHEOSTOMY TUBE , Product Code/List Number/Item Code 60SP040; i) 4.5 UNCUFFED PEDIATRIC TRACHEOSTOMY TUBE , Product Code/List Number/Item Code 60SP045; j) 5.0 UNCUFFED PEDIATRIC TRACHEOSTOMY TUBE , Product Code/List Number/Item Code 60SP050; k) 5.5 UNCUFFED PEDIATRIC TRACHEOSTOMY TUBE , Product Code/List Number/Item Code 60SP055

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