BEUDAMED
    10 results · 27ms · Sources: EU EUDAMED, US FDA

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    Hinged Laminoplasty System

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    Oticon

    FDA UDI
    Oticon A/S·05707131339775·SIYA 1, KIT 312 NFM 90 R C001

    PSYCHEMEDICS METHAMPHETAMINE EIA

    FDA 510(k)
    FDA Class 2 ·Clinical Toxicology

    INTELLIVUE PATIENT MONITORS ,MODELS MP40, MP50, MP60, MP70, MP80, MP90

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    COCHLEAR OSIA OSI300 IMPLANT

    FDA Adverse Event
    Injury ·COCHLEAR LTD·Product code PFO·March 8, 2026

    DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM

    FDA Adverse Event
    Malfunction ·DEXCOM, INC.·Product code QBJ·July 22, 2025

    PROTEUS XR/A

    FDA Adverse Event
    Malfunction ·GE HANGWEI MEDICAL SYSTEMS CO., LTD.·Product code KPR·October 1, 2008

    UNIV-BEND-PLIERS L165

    FDA Adverse Event
    Malfunction ·SYNTHES GMBH·Product code HTC·June 27, 2013

    PERCLOSE PROGLIDE 6F SUTURE MEDIATED CLOSURE (SMC) SYSTEM

    FDA Adverse Event
    Injury ·AV-TEMECULA-CT·Product code MGB·August 4, 2011

    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