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

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    CARDIOBLATE GEMINI SURGICAL ABLATION DEVICE, MODELS 49260 AND 49261

    FDA 510(k)
    FDA Class 2 ·General, Plastic Surgery

    Vial Adaptor

    FDA UDI
    WEST PHARMA. SERVICES IL, . LTD·07290108240474·VA 13mm FLL w/5μm Filter – VF

    MAS PLIF

    FDA UDI
    Nuvasive, Inc.·00887517200969·MAS PLIF Fixation Tap 4.5mm

    General Instruments

    FDA UDI
    ALPHATEC SPINE, INC.·00840180502099·PLIF/TLIF Rotating Disc Shaver/Distractor Combo...

    LIPOMATIC; LIPOMATIC LIPOSUCTION DEVICE

    FDA 510(k)
    FDA Class 2 ·General, Plastic Surgery

    PARAPOST FIBER WHITE

    FDA 510(k)
    FDA Class 1 ·Dental

    PERCLOSE PROGLIDE 6F SUTURE MEDIATED CLOSURE (SMC) SYSTEM

    FDA Adverse Event
    Injury ·AV-TEMECULA-CT·Product code MGB·April 22, 2013

    SETROX S 53

    FDA Adverse Event
    Injury ·BIOTRONIK SE & CO. KG·Product code NVZ·April 18, 2011

    GE OEC 9800

    FDA Adverse Event
    Malfunction ·GE OEC MEDICAL SYSTEM INC.·Product code JAA·July 9, 2008

    Manual bunnell cranial drills are bone cutting and drilling instruments that are used without a power source on a patient's skull sold under the Boss Instruments brand name.

    FDA Enforcement
    Class II ·Terminated·Instrumed International, Inc.·December 17, 2014

    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