BEUDAMED
    14 results · 25ms · Sources: EU EUDAMED, US FDA

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    GROOVY IMPLANTS

    FDA 510(k)
    FDA Class 2 ·Dental

    SM

    FDA UDI
    Covidien LP·10884521080720·Skin Stapler Reload

    Merit Medical®

    FDA UDI
    Merit Medical Systems, Inc.·00884450190449·

    SUPPORT SLEEVE

    FDA 510(k)
    FDA Class 2 ·Gastroenterology, Urology

    HARDYDISK, CIPROFLOXACIN, 5MCG

    FDA 510(k)
    FDA Class 2 ·Microbiology

    RD SET GE - 12

    FDA Adverse Event
    Malfunction ·Product code DQA·August 13, 2021

    LEVULAN KERASTICK WITH BLU-U

    FDA Adverse Event
    Injury ·DUSA PHAMACEUTICALS, INC.·Product code MVF·April 4, 2013

    ALTRUA

    FDA Adverse Event
    Injury ·GUIDANT CRM CLONMEL IRELAND·Product code NVZ·April 12, 2011

    NUCLEUS 24 CHANNEL COCHLEAR IMPLANT SYSTEM

    FDA Adverse Event
    Injury ·COCHLEAR LTD.·Product code MCM·May 22, 2008

    IMPAX CV OUTBOUND (RESULTS MANAGEMENT 2.08)

    FDA Adverse Event
    Malfunction ·AGFA HEALTHCARE CORP·Product code LLZ·September 17, 2013

    BACT/ALERT® FA PLUS BOTTLE

    FDA Adverse Event
    Injury ·BIOMERIEUX INC.·Product code MDB·July 5, 2018

    BACT/ALERT® FA PLUS BOTTLE

    FDA Adverse Event
    Injury ·BIOMERIEUX INC.·Product code MDB·July 5, 2018

    Aurora Series, Aurora 7 lighthead; Models: LED7 (including TV models). The Aurora Series is intended to illuminate the surgical field and ensure visibility of the surgical site.

    FDA Enforcement
    Class II ·Ongoing·DKK Dai-Ichi Shomei Co., Ltd.·August 21, 2024

    Belmont Rapid Infuser, a Fluid Management System, Model FMS2000.

    FDA Enforcement
    Class II ·Terminated·Belmont Instrument Corporation·October 24, 2012