BEUDAMED
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    MENTOR WET-FIELD*II COAGULATOR

    FDA 510(k)
    FDA Class 2 ·Ophthalmic

    Brigade

    FDA UDI
    Nuvasive, Inc.·00887517162670·Brigade Plate Fix Pin, 12mm Threaded

    BURNSHIELD

    FDA UDI
    BURNSHIELD (PTY) LTD·06007645000161·BURNSHIELD BLANK WOOL 2.45mx1.6m(98"X64")

    Snowden-Pencer

    FDA UDI
    STERIS CORPORATION·10885403151248·Snowden-Pencer Plastics DIAMOND-VIEW RETRACTOR ...

    APEX Knee System

    FDA UDI
    Omni Life Science, Inc.·00841690189862·Patella MEDIAL HOLE DRILL GUIDE

    dentaform®

    FDA UDI
    DENTAURUM GmbH & Co.KG·J011881001000·dentaform® Snap Band,Lower, 1. Molar Band left ...

    IntelliSpace Portal DX/HX/EX AutoSPECT Pro Software Application, Philips Medical Systems, Cleveland, OH. Provides software applications used to process, analyze, and display medical images/data.

    FDA Enforcement
    Class II ·Terminated·Philips Medical Systems (Cleveland) Inc·April 27, 2016

    Medtronic Confida Brecker Guidewire

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    PD SYNTH, ABSORBABLE (POLY DIOXANONE) SUTURE

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

    IntelliSpace Portal, M/N 881001, 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.

    FDA Recall
    Terminated ·Philips Medical Systems (Cleveland) Inc·Product code KPS·February 22, 2012

    TRIFUSE

    FDA Adverse Event
    Malfunction ·ICU MEDICAL·Product code FMG·October 3, 2017

    9" SMALLBORE EXT SET W/CLAVE®, CLAMPS, ROTATING LUER

    FDA Adverse Event
    Malfunction ·ICU MEDICAL DE MEXICO, S. DE R.L. DE C.V.·Product code FMG·April 5, 2019

    NexGen®

    FDA UDI
    Zimmer, Inc.·00889024199538·

    NexGen®

    FDA UDI
    Zimmer, Inc.·00889024199545·

    G4 PLATINUM CONTINUOUS GLUCOSE MONITORING SYSTEM

    FDA Adverse Event
    Malfunction ·DEXCOM, INC.·Product code MDS·June 18, 2014

    ESOPHYX2 -04

    FDA Adverse Event
    Malfunction ·REDMOND·Product code ODE·October 6, 2010

    ACRYSOF

    FDA Adverse Event
    Injury ·ALCON LABORATORIES IRELAND LTD.·Product code HQL·December 14, 2012

    9" SMALLBORE EXT SET W/CLAVE®, CLAMPS, ROTATING LUER

    FDA Adverse Event
    Malfunction ·ICU MEDICAL DE MEXICO, S. DE R.L. DE C.V.·Product code FMG·June 5, 2019

    DIAMOND-VIEW RETRACTORSYSTEM 6IN

    FDA Adverse Event
    Malfunction ·CAREFUSION, INC·Product code FDG·March 10, 2020

    IntelliSpace Portal DX/HX/EX model number: 881001 IntelliSpace Portal DX/HX/EX Upgrade model number: 881011 IntelliSpace Portal DX/HX/EX Demo model number: 881012 IntelliSpace Portal IX model number; 881030 System, x-ray, tomography, computed

    FDA Enforcement
    Class II ·Terminated·Philips Medical Systems (Cleveland) Inc·December 3, 2014