BEUDAMED
    7 results · 25ms · Sources: EU EUDAMED, US FDA

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    UNIGRAFE

    FDA 510(k)
    FDA Class 2 ·Dental

    Selethru PTCA Balloon Dilatation Catheter

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    ELECSYS TROPONIN I AND TROPONIN I STAT TEST SYSTEMS

    FDA 510(k)
    FDA Class 2 ·Clinical Chemistry

    GYNECARE MORCELLEX

    FDA Adverse Event
    Malfunction ·ETHICON WOMEN'S HEALTH & UROLOGY·Product code HET·February 22, 2013

    ANIMAS INSULIN INFUSION PUMP

    FDA Adverse Event
    Injury ·ANIMAS CORP.·Product code LZG·February 3, 2011

    SYMBIQ SCHANNEL 3.01

    FDA Adverse Event
    Malfunction ·HOSPIRA COSTA RICA LTD.·Product code FRN·July 24, 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