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

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    HS40 Diagnostic Ultrasound System

    FDA 510(k)
    FDA Class 2 ·Radiology

    BI-METRIC XR-SERIES HIP SYSTEM

    FDA UDI
    Biomet Orthopedics, LLC·00880304650534·

    FUKUSHIMA SUCTION TUBE

    FDA UDI
    SONTEC INSTRUMENTS, INC.·00192896000360·FUKUSHIMA SUCTION TUBE

    BONASTENT® Tracheal/Bronchial

    FDA UDI
    Sewoon Medical Co., Ltd.·08806369469104·

    FUKUSHIMA SUCTION TUBE

    FDA UDI
    SONTEC INSTRUMENTS, INC.·B0991804090·FUKUSHIMA SUCTION TUBE

    Angelwing

    FDA UDI
    SIGNATURE ORTHOPAEDICS PTY LTD·09348215064075·

    POLARIS SPINAL SYSTEM, POLARIS/SYNERGY STRUCTUE ANTERIOR FIXATION SYSTEM

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    ASPIRA PLEURAL DRAINAGE SYSTEM

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    VA LOCKSCR Ø2.4 SELF-TAP L18 TAN

    FDA Adverse Event
    Malfunction ·SYNTHES SELZACH·Product code HRS·August 18, 2017

    ARROR STIM CPNB TUOHY NDL: 18G X 4CM (1-1/2")

    FDA Adverse Event
    Malfunction ·ARROW INTL., INC.·Product code BSP·September 8, 2014

    ARROW STIM CPNB TUOHY NDL: 18G X 4CM (1-1/2")

    FDA Adverse Event
    Malfunction ·ARROW INTL., INC.·Product code BSP·September 8, 2014

    ARROW STIM CPNB TUOHY NDL: 18G X 4CM (1-1/2")

    FDA Adverse Event
    Malfunction ·ARROW INTL., INC.·Product code BSP·September 8, 2014

    HOMECHOICE

    FDA Adverse Event
    Malfunction ·BAXTER HEALTHCARE - LARGO·Product code FKX·June 20, 2013

    HOMECHOICE AUTOMATED PD SET WITH CASSETTE

    FDA Adverse Event
    Injury ·BAXTER HEALTHCARE - MOUNTAIN HOME·Product code FKX·July 27, 2011

    PORTABLE OXYGEN GENERATOR (CONCENTRATOR, HOMEFILL)

    FDA Adverse Event
    Malfunction ·INVACARE FLORIDA OPERATIONS·Product code CAW·October 17, 2014

    PULSE-GENERATOR, PACEMAKER, IMPLANTABLE

    FDA Adverse Event
    Injury ·MEDTRONIC, INC.·Product code DXY·October 30, 2018

    Medtronic Adapter Percutaneous Pin, REF 9734752 (GTIN 00643169529489) and REF 9734752-G02 (GTIN 00763000054915), contained in the following kits: Upgrade Set Percutaneous Pin, REF 9735502 (GTIN 00643169529533) and REF 9735502-G02 (GTIN 00763000208462); Medtronic Adapter Percutaneous Pin Kit, REF 9734752K (GTIN 00643169540521); and Medtronic Adapter Percutaneous Pin Kit, REF 9734752K (GTIN 00643169641006) (Japan). The percutaneous pin adapter is a component of the StealthAir Frame Assembly.

    FDA Enforcement
    Class II ·Terminated·Medtronic Navigation, Inc.·December 25, 2019

    Merge PACS versions 7.3, 7.3.1, 8.0 and 8.0.1

    FDA Enforcement
    Class II ·Terminated·Merge Healthcare, Inc.·July 31, 2019

    Merge OrthoPACS versions 7.3, 7.3.1, 8.0 and 8.0.1

    FDA Enforcement
    Class II ·Terminated·Merge Healthcare, Inc.·July 31, 2019