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

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    DIGITAL RETINAL CAMERA

    FDA 510(k)
    FDA Class 2 ·Ophthalmic

    Bone cutters

    FDA UDI
    DFS - DIAMON GmbH·04057176147936·Bone Cutter type 161 HP

    MicroSelectron Digital

    FDA UDI
    Nucletron B.V.·08717213026193·microSelectron Transfer Tube for 4F Flexibles (30)

    TALOS® IBF

    FDA UDI
    MEDITECH SPINE, LLC·B167311116120·

    TALOS® HA PEEK IBF

    FDA UDI
    MEDITECH SPINE, LLC·B167321116120·

    Specials

    FDA UDI
    Seaspine Orthopedics Corporation·10889981319809·16x14x12 Trial Rasp, w/ Depth Stop

    Biopsy Forceps

    FDA UDI
    ENDO-THERAPEUTICS, INC.·00816207020723·Endoscopic Biopsy Forceps

    MODIFICATION TO HYDROCISION DEBRIDEMENT SYSTEM

    FDA 510(k)
    FDA Class 2 ·General Hospital

    ZEN CORDLESS PROPHY SYSTEM

    FDA 510(k)
    FDA Class 1 ·Dental

    Ascendant

    FDA UDI
    Choice Spine, LP·10885862260840·

    ONETOUCHPING GLUCOSEMGMTSYSTEM

    FDA Adverse Event
    Malfunction ·ANIMAS CORPORATION·Product code LZG·May 14, 2013

    DURALOC OPTION CUP 48MM

    FDA Adverse Event
    Injury ·DEPUY INTERNATIONAL, LTD.·Product code MRA·May 13, 2011

    ORTHO PROVUE

    FDA Adverse Event
    Malfunction ·MICRO TYPING SYSTEMS, INC.·Product code KSZ·August 13, 2008

    AMISTEM-P

    FDA Adverse Event
    Injury ·MEDACTA INTERNATIONAL SA·Product code LZO·April 3, 2026

    INLIVEN CRT-P, Model Numbers: a) V284 b) V285 c) W274 d) W275 (added 7/15/2021)

    FDA Enforcement
    Class I ·Ongoing·Boston Scientific Corporation·July 21, 2021

    ACCOLADE DR EL MRI (Model L331)

    FDA Enforcement
    Class I ·Ongoing·Boston Scientific Corporation·October 22, 2025