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

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    ILUMINAGE DIODE LASER

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

    NA

    FDA UDI
    Smith & Nephew, Inc.·03596010038999·HOKE OSTEOTOME 7.9MM X 127MM

    JOBST Anti-Em

    FDA UDI
    BSN MEDICAL, INC.·00035664114541·ANTI EM TH M-SH W 6 EN FR ES

    MicroSelectron Digital

    FDA UDI
    Nucletron B.V.·08717213032828·Coupling Treatment Tube for Metal Needles (14)

    Merit Medical®

    FDA UDI
    Merit Medical Systems, Inc.·00884450641934·

    MAMMAPRINT

    FDA 510(k)
    FDA Class 2 ·Immunology

    SPINE SCOPE, MODEL 2180

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    GMK-REVISION FIXED TIBIAL INSERT SC SIZE 4/20MM

    FDA Adverse Event
    Injury ·MEDACTA INTERNATIONAL SA·Product code JWH·August 26, 2021

    BD INTIMA-II 22GAX0.75IN PRN SLM NPVC

    FDA Adverse Event
    Malfunction ·BECTON DICKINSON MEDICAL DEVICES CO., LTD. SUZHOU·Product code FOZ·November 9, 2021

    INTERJECT

    FDA Adverse Event
    Malfunction ·BOSTON SCIENTIFIC CORPORATION·Product code FCG·May 27, 2025

    OMNIFIX

    FDA Adverse Event
    Malfunction ·B. BRAUN MELSUNGEN AG·Product code FOZ·April 24, 2013

    PARADIGM REAL-TIME INSULIN INFUSION PUMP

    FDA Adverse Event
    Malfunction ·MEDTRONIC MINIMED·Product code OYC·September 23, 2014

    PINN MAR LIP LNR 28IDX56OD

    FDA Adverse Event
    Injury ·DEPUY ORTHOPAEDICS, INC.·Product code LPH·May 13, 2011

    BMK TIBIAL TRAY FIXED CEMENTED SIZE 4 RIGHT

    FDA Adverse Event
    Injury ·MEDACTA INTERNATIONAL, SA·Product code JWH·April 30, 2015

    SIEMENS SOMATOM with software syngo CT VA30A_SP4 Models: SOMATOM go.Now 11061610 & 11061618 SOMATOM go.Up 11061620 & 11061628 SOMATOM go.All 11061630 & 11061638 SOMATOM go.Top 11061640 & 11061648 SOMATOM go.Sim 11061660 & 11061668 SOMATOM go.Open Pro 11061670 & 11061678 SOMATOM X.cite 11330001 Intended Use: Computed tomography x-ray system

    FDA Enforcement
    Class II ·Ongoing·Siemens Medical Solutions USA, Inc·April 27, 2022

    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

    Model Number L131, ESSENTIO DR EL MRI Pacemaker

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