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

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    EPIGRAY

    FDA 510(k)
    FDA Class 2 ·Radiology

    HEX-FIX

    FDA UDI
    Smith & Nephew, Inc.·03596010042354·HEX-FIX AMSCO HALL ADAPTOR

    Stablecut®

    FDA UDI
    ZIMMER ORTHOPAEDIC SURGICAL PRODUCTS, INC.·00889024493636·

    Stablecut®

    FDA UDI
    ZIMMER ORTHOPAEDIC SURGICAL PRODUCTS, INC.·00846795004560·

    OPTISURE ACTIVE FIXATION, DF-4 CONNECTOR

    FDA Adverse Event
    Injury ·ST. JUDE MEDICAL, INC.(CRM-SUNNYVALE)·Product code NVY·August 12, 2015

    PLATELETWORKS

    FDA 510(k)
    FDA Class 2 ·Hematology

    MODEL 950-12L HOLTER RECORDER WITHOUT ANALYSIS

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    PALMAZ XL STENT PER 50MM OUS

    FDA Adverse Event
    Injury ·CORDIS CORPORATION·Product code FGE·May 14, 2013

    PORTABLE OXYGEN GENERATOR (CONCENTRATOR, HOMEFILL)

    FDA Adverse Event
    Malfunction ·INVACARE FLORIDA OPERATIONS·Product code CAW·September 24, 2014

    VERSACARE

    FDA Adverse Event
    Malfunction ·HILL-ROM RITTER·Product code FNL·August 15, 2008

    IOL Master 500: Software versions 7.5 and 7.7; Ophthalmic: IOL Master 500 is intended for biometric determination of ocular measurements of axial length, anterior chamber depth, corneal radius, white-to white (WTW), and for the measurement of pupil size and deviation of the visual axis from the center of the pupil.

    FDA Enforcement
    Class II ·Terminated·Carl Zeiss Meditec AG·December 9, 2015

    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