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

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    DISTAL RADIO-ULNAR JOINT IMPLANT

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    Leksell Stereotactic System

    FDA UDI
    Elekta Solutions AB·07340201502938·Ear Plug Holders - ATTACHMENT, EAR PLUG RIGHT

    VOYAGER/VIPER WHEELCHAIR

    FDA 510(k)
    FDA Class 1 ·Physical Medicine

    SILVERSPEED HYDROPHILIC GUIDEWIRE, MODELS 103-0601-300 AND 103-0602-300

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    HEARTSTART XL

    FDA Adverse Event
    Malfunction ·PHILIPS MEDICAL SYSTEMS·Product code MKJ·February 6, 2013

    6461500 INFUSOR PUMP (1 LABEL)

    FDA Adverse Event
    Malfunction ·BAXTER HEALTHCARE - SINGAPORE·Product code FRN·April 6, 2011

    LIBERTE MONORAIL CORONARY STENT DELIVERY SYSTEM

    FDA Adverse Event
    Injury ·BOSTON SCIENTIFIC CORPORATION·Product code MAF·May 9, 2008

    Aurora 4 Series, Aurora 7 lighthead; Models: AUA7 (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

    Azurion 7 M20; Catalog numbers: (1) 722079, (2) 722224, (3) 722234, (4) 722282 (OUS ONLY);

    FDA Enforcement
    Class I ·Ongoing·PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.·February 26, 2025