BEUDAMED
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    NANGEL

    FDA 510(k)
    FDA Class 2 ·Dental

    Integra® Miltex®

    FDA UDI
    INTEGRA LIFESCIENCES PRODUCTION CORPORATION·10381780169413·Integra® Miltex® Cassette, Utility, Series 5, 8...

    CosmoLock Pedicle Screw System

    FDA UDI
    Kalitec Direct LLC·B07311K0330050·Vise Grip, Large, 5.5mm

    N.A.

    FDA UDI
    Forestadent Bernhard Förster GmbH·EFOR76000830051·Lingual cleat on pad max. right / mand. left

    Leucadia Autolok" Polyaxial Pedicle Screw System. Intended to help provide correction, immobilization and stabilization of spinal segments.

    FDA Enforcement
    Class II ·Terminated·Alphatec Spine, Inc.·June 5, 2013

    NOBELACTIVE INTERNAL RP 4.3X8.5MM

    FDA Adverse Event
    Injury ·NOBEL BIOCARE AB·Product code DZE·August 17, 2020

    NOBELACTIVE INTERNAL NP 3.5X8.5MM

    FDA Adverse Event
    Injury ·NOBEL BIOCARE AB·Product code DZE·September 9, 2020

    NOBELACTIVE INTERNAL NP 3.5X8.5MM

    FDA Adverse Event
    Injury ·NOBEL BIOCARE AB·Product code DZE·September 9, 2020

    NOBELACTIVE INTERNAL RP 4.3X8.5MM

    FDA Adverse Event
    Injury ·NOBEL BIOCARE AB·Product code DZE·August 17, 2020

    TISSUELINK BIPOLAR FORCEPS

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

    ACT 11 MP VENTRICULAR CATHETER

    FDA 510(k)
    FDA Class 2 ·Neurology

    SOLETRA

    FDA Adverse Event
    Malfunction ·MEDTRONIC NEUROMODULATION·Product code MHY·April 29, 2013

    BOVIE PENCIL AND INSULATED COATED BLADE TIP

    FDA Adverse Event
    Injury ·VALLEY LAB·Product code GEI·May 4, 2011

    ENDEAVOR RX CORONARY STENT SYSTEM

    FDA Adverse Event
    Injury ·MEDTRONIC CARDIOVASCULAR GALWAY·Product code NIQ·July 28, 2008

    BD PYXIS¿ MEDSTATION¿ ES

    FDA Adverse Event
    Malfunction ·CAREFUSION 303, INC.·Product code BRY·January 22, 2026

    Vitrea 5.1. Vitrea fX 3.0, Vitrea Enterprise Suite 1.2 with the licensing of CT lung or CT Colon.

    FDA Recall
    Terminated ·Vital Images, Inc.·Product code LLZ·February 23, 2010

    Advisor Vital Signs Monitor (model 9200) with Capnography options installed (model 9212S or model 9212A), catalog no. 925654325.

    FDA Recall
    Terminated ·Smiths Medical PM, Inc.·Product code DPS·March 16, 2005

    Vitrea CT Brain Perfusion made available in various configurations under the names Vitrea, Vitrea fX, VitreaAdvanced and Vitrea Enterprise Suite. Noninvasive post-processing application designed to evaluate areas of brain perfusion.

    FDA Recall
    Terminated ·Vital Images, Inc.·Product code LLZ·March 15, 2013

    Vitrea CT Multi-Chamber Cardiac Functional Analysis application on Vitrea version 5.2 (Vitrea Enterprise Suite 1.3 and Vitrea fX 3.1) and subsequent versions of VitreaWorkstation, Vitrea fX, VitreaAdvanced and Vitrea Enterprise Suite, through version 6.4. Vitrea CT Multi-Chamber Cardiac Functional Analysis provides a variety of tools for working with clinical CT images of the coronary arteries, heart, and surrounding tissue.

    FDA Recall
    Terminated ·Vital Images, Inc.·Product code LLZ·March 15, 2013

    Vitrea (available in various configuration as Vitrea Enterprise Suite). Vitrea Enterprise Suite 1.2, Vitrea Enterprise Suite 1.3, Vitrea enterprise Suite 6.0 and Vitrea Enterprise Suite 6.1. A medical diagnostic system that allows the processing, review, analysis, communication and media interchange of multi-dimensional digital images acquired from variety of imaging devices.

    FDA Recall
    Terminated ·Vital Images, Inc.·Product code LLZ·November 11, 2011