BEUDAMED
    9 results · 26ms · Sources: EU EUDAMED, US FDA

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    PRE-PADDED PLASTER/PARIS BAND/SPLINTS

    FDA 510(k)
    FDA Class 1 ·Physical Medicine

    ACUMED

    FDA UDI
    Acumed LLC·10806378044489·Acu-Loc® 2 Implant Platter

    RHIGENE MESACUP2 TEST- RNP

    FDA 510(k)
    FDA Class 2 ·Immunology

    CONCEIVEX LATEX-FREE SEMEN COLLECTOR

    FDA 510(k)
    FDA Class 2 ·Obstetrics/Gynecology

    PINNACLE SECTOR II CUP 52MM

    FDA Adverse Event
    Injury ·DEPUY ORTHOPAEDICS, INC.·Product code LPH·May 8, 2014

    ACRYSOF RESTOR

    FDA Adverse Event
    Injury ·ALCON RESEARCH, LTD./HUNTINGTON·Product code HQL·October 17, 2012

    COLLEAGUE CXE VOLUMETRICINFUSION PUMP

    FDA Adverse Event
    Malfunction ·BAXTER HEALTHCARE - SINGAPORE·Product code FRN·August 16, 2010

    Product Label - ACUSON Sequoia *** Power Input: 100-240V~, 13.0-5.4A, 50-60Hz *** (240)11148775 Model User Manual states - ACUSON Sequoia Diagnostic Ultrasound Systems

    FDA Enforcement
    Class II ·Ongoing·Siemens Medical Solutions USA, Inc.·April 7, 2021

    Access Immunoassay Systems (1) Access 2 Immunoassay Analyzer (81600N); (2) Access 2 Immunoassay Analyzer, Refurbished (386220); (3) Access 2 Immunoassay Analyzer, Refurbished (A65531) ; and (4) Access 2 Section, DxC 600i Packaged(A25640).

    FDA Enforcement
    Class II ·Ongoing·Beckman Coulter, Inc.·March 22, 2023