BEUDAMED
    9 results · 26ms · Sources: EU EUDAMED, US FDA

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    PHILIPS EASYVISION

    FDA 510(k)
    FDA Class 2 ·Radiology

    De Soutter Medical

    FDA UDI
    DE SOUTTER MEDICAL LIMITED·05051471123113·K-WIRE - DOUBLE TROCAR 0.9mm DIA x 125mm

    TOTAL CHOLESTEROL REAGENT SET

    FDA 510(k)
    FDA Class 1 ·Clinical Chemistry

    SPECTRAL'S 2 IN 1 (TNI-MYO)

    FDA 510(k)
    FDA Class 2 ·Clinical Chemistry

    CAPSUREFIX NOVUS

    FDA Adverse Event
    Malfunction ·MEDTRONIC PUERTO RICO, INC.·Product code DTB·December 13, 2010

    TENSION FREE VAGINAL TAPE

    FDA Adverse Event
    Injury ·ETHICON, INC.·Product code OTN·January 17, 2013

    ADAPTER SLEEVES 12/14 +5

    FDA Adverse Event
    Malfunction ·DEPUY INTERNATIONAL LTD.-8010379·Product code KWA·July 8, 2014

    REGENEREX PEG SERIES PATELLA

    FDA Adverse Event
    Injury ·ZIMMER BIOMET, INC.·Product code JWH·December 28, 2017

    PORTEX Bivona Tracheostomy Silicone Tube, labeled as: a) 3.0MM FLEXTEND PEDIATRIC STANDARD STRAIGHT TRACH TUBE , Product Code/List Number/Item Code 60PFSS30; b) 3.5MM FLEXTEND PEDIATRIC STANDARD STRAIGHT TRACH TUBE , Product Code/List Number/Item Code 60PFSS35; c) 4.0MM FLEXTEND PEDIATRIC STANDARD STRAIGHT TRACH TUBE TRACH TUBE , Product Code/List Number/Item Code 60PFSS40; d) 4.5MM FLEXTEND PEDIATRIC STANDARD STRAIGHT TRACH TUBE , Product Code/List Number/Item Code 60PFSS45; e) 5.0MM FLEXTEND PEDIATRIC STANDARD STRAIGHT TRACH TUBE , Product Code/List Number/Item Code 60PFSS50; f) 5.5MM FLEXTEND PEDIATRIC STANDARD STRAIGHT TRACH TUBE , Product Code/List Number/Item Code 60PFSS55

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