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

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    S-ROM SUPERCUP ACETABULAR CUP

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    Arthrex

    FDA UDI
    Provision·B504OMAR18700880·

    Arthrex®

    FDA UDI
    ARTHREX, INC.·00888867381391·Drill Bit, 1.2 mm, AO

    Persona®

    FDA UDI
    Zimmer, Inc.·00889024550995·

    Persona®

    FDA UDI
    Zimmer, Inc.·00889024551084·

    Invia Foam Dressing Kits with FitPad, Invia Foam Dressing Kits with FitPad, Invia Gauze Dressing Kits with FitPad, Invia FitPad, Invia Transparent Film

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

    ASSURE 4 BLOOD GLUCOSE MONITORING SYSTEM

    FDA 510(k)
    FDA Class 2 ·Clinical Chemistry

    VICRYL (POLYGLACTIN 910) SUTURE

    FDA Adverse Event
    Injury ·ETHICON INC.·Product code GAM·June 12, 2014

    ICL (IMPLANTABLE COLLAMER LENS)

    FDA Adverse Event
    Injury ·STAAR SURGICAL CO.·Product code MTA·October 5, 2010

    PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP

    FDA Adverse Event
    Injury ·MEDTRONIC MINIMED·Product code OYC·December 12, 2012

    IntelliSpace Portal (ISP) DX/HX/EX, IntelliSpace Portal (ISP) IX, and IntelliSpace Portal (ISP) LX SPECT IntelliSpace Portal (ISP) is a multimodality (CT, NM, and MR) thin-client applications server that delivers full diagnostic viewing and clinical applications to the enterprise. IntelliSpace Portal (ISP) is a medical software system that allows multiple users to remotely access IntelliSpace Workspace Portal (ISP) from compatible computers on a network. The system allows networking, selection, processing and filming of multimodality DICOM images.

    FDA Enforcement
    Class II ·Terminated·Philips Medical Systems (Cleveland) Inc·August 20, 2014