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

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    BICARBONATE PROCEDURE

    FDA 510(k)
    FDA Class 2 ·Clinical Chemistry

    GC Initial™

    FDA UDI
    Gc America Inc.·15400556700911·GC Initial™ MC Dentin DC3, 20g

    GC Initial™

    FDA UDI
    Gc America Inc.·J0228700621·GC Initial™ MC Dentin DC3, 20g

    APEX Knee System

    FDA UDI
    Omni Life Science, Inc.·00841690190042·EAG Ankle Clamp

    Arthrex®

    FDA UDI
    ARTHREX, INC.·00888867316317·VAL Drill Guide, Cone Shaped, 2.4mm

    Cap, Cervical, Contraceptive

    FDA Pre-Market Approval
    FDA Class 3 ·PRENTIF TM CAVITY RIM CERVICAL CAP

    COPROSET SALMONELLA AND SHIGELLA, URISET PRESERVATIVE TUBES AND SWAB SET GENERAL USE

    FDA 510(k)
    FDA Class 1 ·Microbiology

    GDH-GLUCOSE (RATE) REAGENT KIT

    FDA 510(k)

    Cap, Cervical, Contraceptive

    FDA Pre-Market Approval
    FDA Class 3 ·PRENTIF TM CAVITY RIM CERVICAL CAP

    NEUROFORM 3 EZ- 4.5 X 20MM

    FDA Adverse Event
    Injury ·STRYKER NEUROVASCULAR CORK·Product code NJE·June 12, 2014

    SPRINT FIDELIS

    FDA Adverse Event
    Death ·MEDTRONIC PUERTO RICO, INC.·Product code LWS·October 15, 2010

    PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP H

    FDA Adverse Event
    Injury ·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

    OPTETRAK Comprehensive Knee System including OPTETRAK Logic RBK PS Tibial Components (Product Line: 02-012-38-XXXX). NOTE: Information reflects Exactech recall expansion initiated on 02/07/2022.

    FDA Enforcement
    Class II ·Ongoing·Exactech, Inc.·October 13, 2021