BEUDAMED
    20 results · 22ms · Sources: EU EUDAMED, US FDA

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    LESSER METATARSAL HEAD IMPLANT SYSTEM

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    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

    PATCH, PLEDGET AND INTRACARDIAC

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    HEARTSTART MRX, MODEL M3535A

    FDA 510(k)
    FDA Class 3 ·Cardiovascular

    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

    AC-POWERED ADJUSTABLE HOSPITAL BED, INCLUDING RAILS

    FDA Adverse Event
    Malfunction ·INVACARE CONTINUING CARE·Product code FNL·October 1, 2014

    MED-EL MAESTRO COCHLEAR IMPLANT SYSTEM

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

    SELECTION

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

    Universal Tray Catalog 1567

    FDA Enforcement
    Class II ·Terminated·Busse Hospital Disposables, Inc.·June 8, 2022

    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

    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

    Alaris Syringe Pump, Model No. 8110. Delivers fluids. Expansion of Affected Units: BOM Housing Assembly Service, Part No. 49000226, and Lower Housing/Carriage Block Assembly, Part No. 148188-100.

    FDA Enforcement
    Class I ·Terminated·CareFusion 303, Inc.·August 26, 2015

    Allura Exper FD Series. System codes 722003 722010 722022 722005 722011 722019 722001 722002 722006 722012 722008 722013 722020 722025 722015 722023 722038 889006 889016 889009 722005 The device is an X-Ray Generator.

    FDA Enforcement
    Class II ·Terminated·Philips North America, LLC·March 25, 2020