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

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    ROCHE UNIMATE 3/UNIMATE 5 HBA1C, HBA1C CALIBRATOR, HBA1C CONTROLS N & P

    FDA 510(k)
    FDA Class 2 ·Hematology

    MONOCHROME LCD MONITOR, MODEL RADIFORCE G33

    FDA 510(k)
    FDA Class 2 ·Radiology

    cryoFORM cryoICE cryoablation probe

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

    VERSYS FEMORAL STEM

    FDA Adverse Event
    Injury ·ZIMMER INC·Product code LPH·February 25, 2016

    TARGET TIP

    FDA Adverse Event
    Malfunction ·MPRI·Product code DTB·February 9, 2013

    E SERIES DEFIBRILLATOR

    FDA Adverse Event
    Malfunction ·ZOLL MEDICAL CORPORATION·Product code MKJ·December 30, 2010

    OT ULTRA METER

    FDA Adverse Event
    Injury ·LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL·Product code NBW·July 23, 2014

    PORTEX Bivona Tracheostomy Silicone Tube, labeled as: a) 4.0MM FLEXTEND PEDIATRIC PLUS STRAIGHT TRACH TUBE , Product Code/List Number/Item Code 60PFPS40; b) 4.5MM FLEXTEND PEDIATRIC PLUS STRAIGHT TRACH TUBE , Product Code/List Number/Item Code 60PFPS45; c) 5.0MM FLEXTEND PEDIATRIC PLUS STRAIGHT TRACH TUBE , Product Code/List Number/Item Code 60PFPS50; d) 5.5MM FLEXTEND PEDIATRIC PLUS STRIAGHT TRACH TUBE , Product Code/List Number/Item Code 60PFPS55; e) 6.0MM FLEXTEND PEDIATRIC PLUS STRAIGHT TRACH TUBE , Product Code/List Number/Item Code 60PFPS60

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