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

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    IMAGE FULL POWER EXAMINATION/MINOR SURGERY TABLE

    FDA 510(k)
    FDA Class 1 ·General, Plastic Surgery

    HEINE BETA 200, HEINE BETA 200 S, HEINE K 180

    FDA 510(k)
    FDA Class 2 ·Ophthalmic

    PROCEDUR 10 SYRINGE DEVICE

    FDA 510(k)
    FDA Class 2 ·General Hospital

    APC PLUS, CLARITY, MINI UNI-TWIN, VICTORY SERIES

    FDA Adverse Event
    Injury ·3M UNITEK·Product code DYH·May 9, 2012

    STEALTHSTATION TREON TREATMENT GUIDANCE SYSTEM

    FDA Adverse Event
    MEDTRONIC NAVIGATION·Product code HAW·November 22, 2010

    COULTER® HMX CAP PIERCE HEMATOLOGY ANALYZER

    FDA Adverse Event
    Malfunction ·BECKMAN COULTER·Product code GKZ·February 4, 2013

    DIMENSION EXL 200

    FDA Adverse Event
    Malfunction ·SIEMENS HEALTHCARE DIAGNOSTICS INC.·Product code JJE·July 17, 2014

    PORTEX Bivona Tracheostomy Silicone Tube, labeled as: a) PAED. TRACHEOSTOMY TUBE 2.5MM UNCUFFED , Product Code/List Number/Item Code 60P025; b) PAED. TRACHEOSTOMY TUBE 3.0MM UNCUFFED , Product Code/List Number/Item Code 60P030; c) PAED. TRACHEOSTOMY TUBE 3.5MM UNCUFFED , Product Code/List Number/Item Code 60P035; d) PAED. TRACHEOSTOMY TUBE 4.0MM UNCUFFED , Product Code/List Number/Item Code 60P040; e) PAED. TRACHEOSTOMY TUBE 4.5MM UNCUFFED , Product Code/List Number/Item Code 60P045; f) PAED. TRACHEOSTOMY TUBE 5.0MM UNCUFFED , Product Code/List Number/Item Code 60P050; g) PAED. TRACHEOSTOMY TUBE 5.5MM UNCUFFED , Product Code/List Number/Item Code 60P055

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