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    FoundationOne CDx test report

    FDA Recall
    Terminated ·Foundation Medicine, Inc.·Product code PQP·August 8, 2019

    LIFEPAK CR Plus Automated External Defibrillator. Device is primarily deployed in Public Access Defibrillator (PAD). It is a small lightweight device intended for use by minimally trained responders to treat victims of sudden cardiac arrest... Product is capable of 30 full discharges. Labeling on the device states LIFEPAK CR Plus LIFEPAK EXPRESS Defibrillators with ADAPTIV Biphasic Technology; Medtronic Emergency Response Systems, Inc. 11811 Willows Road NE Redmond, WA.

    FDA Recall
    Terminated ·Physio Control, Inc.·Product code MJK·August 28, 2008

    CME America BodyGuard Infusion Pump System, All models of BG 323, BG 121, BG 545, BG CV545, BG 575, BG CV575, and CMExpress

    FDA Recall
    Terminated ·CME America, LLC·Product code FRN·January 7, 2020

    Acetabular Pressurizer; single use and six units per box. The Acetabular Pressurizer 0206-522-000 is an accessory to the Advanced Cement Mixer (ACM). The Acetabular Pressurizer Tiplet P/N 0206-522-012 is sealed in a two pouches, sterilized, and labeled as part number 0206-522-000. This Acetabular Pressurizer is an accessory used to pressurize the cement applied to the prosthesis to be implanted during the surgery. The Acetabular Pressurizer is an injection molded component made with resin material DOW HDPD 10462N which is a rigid plastic once it is molded.

    FDA Recall
    Terminated ·Stryker Instruments Div. of Stryker Corporation·Product code JDZ·November 1, 2013

    Medtronic COMPLETE SE Self Expanding Biliary Stent System, Model number SC760L, includes a pre-loaded self-expanding Nickel-Titanium (Nitinol) stent with 8 tantalum radiopaque markers, 4 on each end, and an over the wire retractable sheath delivery system.

    FDA Recall
    Terminated ·Medtronic Cardiovascular·Product code FGE·November 24, 2008

    GE Healthcare, CT Perfusion 4 on Advantage Workstation, CT and PET/CT consoles. Image analysis software package that allows the user to produce image data and to generate information with regard to changes in image intensity over time supporting CT Perfusion images.

    FDA Recall
    Terminated ·GE Medical Systems, LLC·Product code JAK·May 4, 2009

    Portex 3 Way Stopcock Catalog Number: T1103

    FDA Recall
    Terminated ·Smiths Medical ASD, Inc.·Product code FMG·September 9, 2004

    Portex 3 Way Stopcock Catalog Number: T1202

    FDA Recall
    Terminated ·Smiths Medical ASD, Inc.·Product code FMG·September 9, 2004

    Portex ULTRA-FLO 4 - Way Stopcock Catalog Number: T1209

    FDA Recall
    Terminated ·Smiths Medical ASD, Inc.·Product code FMG·September 9, 2004

    Portex Custom Pro-Vent Arterial Blood Sampling Kit Catalog Number: G1481

    FDA Recall
    Terminated ·Smiths Medical ASD, Inc.·Product code JKA·September 9, 2004

    Portex 4-Way Stopcock Catalog Number: T1206

    FDA Recall
    Terminated ·Smiths Medical ASD, Inc.·Product code FMG·September 9, 2004

    Portex Custom Pro-Vent Arterial Blood Sampling Kit Catalog Number: G1554

    FDA Recall
    Terminated ·Smiths Medical ASD, Inc.·Product code JKA·September 9, 2004

    Portex 4 Way ''T-Handle'' Stopcock Catalog Number: T1204

    FDA Recall
    Terminated ·Smiths Medical ASD, Inc.·Product code FMG·September 9, 2004

    Portex High Pressure 4 - Way Stopcock Catalog Number: T8202

    FDA Recall
    Terminated ·Smiths Medical ASD, Inc.·Product code FMG·September 9, 2004

    Salivary Estradiol ELISA, REF SLV-4188 in vitro diagnostic quantitative measurement of active free Estradiol, an estrogenic steroid, in saliva.

    FDA Recall
    Terminated ·DRG Instruments GmbH Frauenbergstr. 18 Marburg Germany·Product code PEJ·July 14, 2016

    Fiberoptic Bronchoscope Dual-Axis Swivel Adapter Catalog Number: 625191

    FDA Recall
    Terminated ·Smiths Medical ASD, Inc.·September 9, 2004

    Portex Custom Pro-Vent Arterial Blood Sampling Kit Catalog Number: G1696

    FDA Recall
    Terminated ·Smiths Medical ASD, Inc.·Product code JKA·September 9, 2004

    Portex Custom Pro-Vent Arterial Blood Sampling Kit Catalog Number: G1515

    FDA Recall
    Terminated ·Smiths Medical ASD, Inc.·Product code JKA·September 9, 2004

    Portex Custom Pro-Vent Arterial Blood Sampling Kit Catalog Number: G1576

    FDA Recall
    Terminated ·Smiths Medical ASD, Inc.·Product code JKA·September 9, 2004

    Portex Dual-Axis Swivel Adapter Catalog Number: 525151

    FDA Recall
    Terminated ·Smiths Medical ASD, Inc.·September 9, 2004