BEUDAMED
    11 results · 21ms · Sources: EU EUDAMED, US FDA

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    Fiagon Navigation System

    FDA 510(k)
    FDA Class 2 ·Neurology

    K162309

    FDA Adverse Event
    Malfunction ·MEDTRONIC NAVIGATION, INC·Product code PGW·November 14, 2019

    VERIGENE RESPIRATORY VIRUS NUCLEIC ACID TEST +(RVNAT+)

    FDA 510(k)
    FDA Class 2 ·Microbiology

    HBA1C; CALIBRATOR; CONTROL NORMAL, CONTROL ABNORMAL

    FDA 510(k)
    FDA Class 2 ·Hematology

    ORAL B FLEXISOFT

    FDA Adverse Event
    Other ·BRAUN·Product code EFW·October 7, 2014

    UNKNOWN 40/58 ALTRX LINER +4N

    FDA Adverse Event
    Injury ·DEPUY ORTHOPAEDICS, INC.·Product code LPH·July 8, 2011

    LIGAMAX-5MM ENDO CLIP APPLIER

    FDA Adverse Event
    Malfunction ·ETHICON ENDO-SURGERY, LLC.·Product code FZP·June 11, 2013

    SYRINGE 30ML LL S/C 56

    FDA Adverse Event
    Malfunction ·BD MEDICAL (BD WEST) MEDICAL SURGICAL·Product code FMF·April 13, 2021

    SYRINGE 30ML LL S/C 56

    FDA Adverse Event
    Malfunction ·BD MEDICAL (BD WEST) MEDICAL SURGICAL·Product code FMF·April 13, 2021

    VGI MEDICAL VerteLP LATERAL INTERBODY FUSION instrument kit

    FDA Enforcement
    Class II ·Terminated·VGI Medical, LLC·June 13, 2018

    cobas 6000 Modular Series system; Part Numbers: 1. 04745914001 cobas c 501 module; 2. 05036453001 cobas 6000 UL c 501 + Core Fix configuration; 3. 05036453692 - cobas 6000 UL + CORE CU; and 4. 05860636001 cobas 6000 c 501 (UL) V

    FDA Enforcement
    Class II ·Terminated·Roche Diagnostics Corporation·March 14, 2018