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

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    ANA SCREEN ELISA (IGG)

    FDA 510(k)
    FDA Class 2 ·Immunology

    3.5MM CORTEX SCREW SELF-TAPPING 55MM

    FDA Adverse Event
    Injury ·SYNTHES MONUMENT·Product code HWC·January 26, 2017

    SCREW, FIXATION, BONE

    FDA Adverse Event
    Injury ·WRIGHTS LANE SYNTHES USA PRODUCTS LLC·Product code HWC·July 25, 2018

    NUCLEIC ACID DETECTION IMMUNOASSAY (NADIA) PSA ASSAY

    FDA 510(k)
    FDA Class 2 ·Immunology

    ABBOTT PLUM A+ INFUSION PUMP WITH A HPL/RS PLUG-AND-PLAY MODULE

    FDA 510(k)
    FDA Class 2 ·General Hospital

    SCREW, FIXATION, BONE

    FDA Adverse Event
    Injury ·SYNTHES USA·Product code HWC·November 18, 2015

    SCREW, FIXATION, BONE

    FDA Adverse Event
    Injury ·WRIGHTS LANE SYNTHES USA PRODUCTS LLC·Product code HWC·June 7, 2018

    3.5MM CORTEX SCREW SELF-TAPPING 16MM

    FDA Adverse Event
    Injury ·SYNTHES USA·Product code HWC·January 6, 2016

    3.5MM CORTEX SCREW SELF-TAPPING 14MM

    FDA Adverse Event
    Injury ·SYNTHES USA·Product code HWC·January 6, 2016

    ACCU-CHEK ® PERFORMA TEST STRIPS

    FDA Adverse Event
    Malfunction ·ROCHE DIAGNOSTICS·Product code LFR·October 1, 2014

    MED-EL MAESTRO COCHLEAR IMPLANT SYSTEM

    FDA Adverse Event
    Malfunction ·MED-EL ELEKTROMEDIZINISCHE GERAETE GMBH·Product code MCM·May 22, 2013

    VITA 2

    FDA Adverse Event
    Injury ·MEDTRONIC S.A.·Product code NVZ·June 16, 2011

    CORTSCR 3.5 SELF-TAP L65 TI

    FDA Adverse Event
    Malfunction ·SYNTHES (USA)·Product code HWC·April 29, 2013

    3.5MM CORTEX SCREW SELF-TAPPING 22MM

    FDA Adverse Event
    Injury ·SYNTHES USA·Product code HWC·December 21, 2015

    PENTAX

    FDA Adverse Event
    Malfunction ·HOYA CORPORATION PENTAX TOKYO OFFICE·Product code FDF·September 14, 2021

    SCREW, FIXATION, BONE

    FDA Adverse Event
    Injury ·SYNTHES (USA)·Product code HWC·January 4, 2016

    SCREW, FIXATION, BONE

    FDA Adverse Event
    Injury ·SYNTHES USA·Product code HWC·July 14, 2016

    3.5MM TI CORTEX SCREW 36MM

    FDA Adverse Event
    Malfunction ·SYNTHES TRAUMA : OBERDORF : SYNTHES PRODUKTIONS GM·Product code HWC·February 9, 2018

    PENTAX

    FDA Adverse Event
    Malfunction ·HOYA CORPORATION PENTAX TOKYO OFFICE·Product code FDF·September 14, 2021

    Philips Allura Xper Systems (R7.6-R8.1). Labeled as the following: 1. Allura Xper FD10, Model Number: 722010. 2. Allura Xper FD10/10, Model Number: 722011. 3. Allura Xper FD20, Model Number: 722012. 4. Allura Xper FD20 Biplane, Model Number: 722013. 5. Allura Xper FD10 OR Table, Model Number: 722022. 6. Allura Xper FD20 OR Table, Model Number: 722023. 7. Allura Xper FD20 Biplane OR Table, Model Number: 722025.

    FDA Enforcement
    Class II ·Ongoing·PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.·December 18, 2024