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

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    OXOID STREPTOMYCIN ANTIMICROBIAL SUSCEPTIBILITY TEST DISC

    FDA 510(k)
    FDA Class 2 ·Microbiology

    Youlaser CO2

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

    APPOLLO BATH

    FDA 510(k)
    FDA Class 2 ·Physical Medicine

    ASCENT SYSTEM-BEARING

    FDA Adverse Event
    Injury ·BIOMET ORTHOPEDICS·Product code JWH·December 28, 2016

    R SERIES DEFIBRILLATOR

    FDA Adverse Event
    Malfunction ·ZOLL MEDICAL CORPORATION·Product code MKJ·June 16, 2014

    OSTEO-WEDGE OPENING WEDGE BONE LOCKING SYSTEM

    FDA Adverse Event
    Malfunction ·RAHAM MEDICAL TECHNOLOGIES LLC (DBA GRAMEDICA)·Product code HRS·February 25, 2013

    AUTOMATED BLOOD PRESSURE MONITOR WITH ARM CUFF

    FDA Adverse Event
    Injury ·OMRON (DALIAN) CO., LTD. (PLANT 1)·Product code DXN·December 14, 2010

    PORTEX Bivona Tracheostomy Silicone Tube, labeled as: a) PAED. TRACHEOSTOMY TUBE 2.5MM STANDARD FLEXTEND PLUS , Product Code/List Number/Item Code 60PFS25; b) PAED. TRACHEOSTOMY TUBE 3.0MM STANDARD FLEXTEND PLUS , Product Code/List Number/Item Code 60PFS30; c) PAED. TRACHEOSTOMY TUBE 3.5MM STANDARD FLEXTEND PLUS , Product Code/List Number/Item Code 60PFS35; d) PAED. TRACHEOSTOMY TUBE 4.0MM STANDARD FLEXTEND PLUS , Product Code/List Number/Item Code 60PFS40; e) PAED. TRACHEOSTOMY TUBE 4.5MM STANDARD FLEXTEND PLUS , Product Code/List Number/Item Code 60PFS45; f) PAED. TRACHEOSTOMY TUBE 5.0MM STANDARD FLEXTEND PLUS , Product Code/List Number/Item Code 60PFS50; g) PAED. TRACHEOSTOMY TUBE 5.5MM STANDARD FLEXTEND PLUS , Product Code/List Number/Item Code 60PFS55

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