BEUDAMED
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    Lumenis VersaCut+ Tissue Morcellator GA-0007500 The Lumenis VersaCut / VersaCut+ Tissue Morcellator System is intended for use under direct or endoscopic visualization for the morcellation and removal of dissected tissue during pelviscopic, laparoscopic, percutaneous, and open surgical procedures whenever access to the surgical site is limited.

    FDA Enforcement
    Class II ·Terminated·Lumenis·September 23, 2015

    Model 6000 CMS, CMS IOD, or Plus Ambulatory Infusion Pump, Model Number: 360-1101

    FDA Recall
    Terminated ·Curlin Medical Llc·Product code FRN·May 30, 2008

    Physio-Control LIFEPAK 20 defibrillator/monitor is indicated for the termination of certain potentially fatal arrhythmias, such as ventricular fibrillation and symptomatic ventricular tachycardia.

    FDA Recall
    Terminated ·Physio Control, Inc.·Product code LDD·April 16, 2008

    Orthopedic manual Surgical Instrument handle for Simple Locking Intra Medullary (SLIM) System - Product Usage: The SLIM handle is the grip for the SLIM driver in orthopedic surgical procedures.

    FDA Enforcement
    Class III ·Terminated·Pega Medical Inc.·May 27, 2020

    HeartSine Samaritan(R) 300/300P PAD devices with serial numbers 0400000501 to 0700032917; 08A00035000 to 10A0070753; 10C00200000 to 10C00210106 Product Usage: Samaritan 300/300P PAD is indicated for use on victims of sudden cardiac arrest who are exhibiting the following signs: Unconsciousness Not breathing Without circulation

    FDA Enforcement
    Class I ·Terminated·Heartsine Technologies, Limited·November 7, 2012

    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

    iPico Product Usage: Muscle stimulation

    FDA Recall
    Terminated ·Ion Genius, Inc.·Product code NFO·January 6, 2012

    Perfector Product Usage: Muscle stimulation

    FDA Recall
    Terminated ·Ion Genius, Inc.·Product code IPF·January 6, 2012

    Ion Magnum Product Usage: Muscle stimulation

    FDA Recall
    Terminated ·Ion Genius, Inc.·Product code IPF·January 6, 2012

    IELLIOS Product Usage: Muscle stimulation

    FDA Recall
    Terminated ·Ion Genius, Inc.·Product code NFO·January 6, 2012

    Arasys Product Usage: Muscle stimulation

    FDA Recall
    Terminated ·Ion Genius, Inc.·Product code IPF·January 6, 2012

    ArcPoint Labs 5 Panel Dip Drug Screen, Part No. APD-5M. The ArcPoint Labs Dip Drug Screen Dip Card is a one-step immunoassay for the qualitative detection of multiple drugs and drug metabolites in human urine.

    FDA Enforcement
    Class II ·Terminated·Ameditech Inc·October 22, 2014

    ArcPoint Labs 10 Panel Dip Screen (OXY), Part No. APD-10MO. The ArcPoint Labs Dip Drug Screen Dip Card is a one-step immunoassay for the qualitative detection of multiple drugs and drug metabolites in human urine.

    FDA Enforcement
    Class II ·Terminated·Ameditech Inc·October 22, 2014

    ArcPoint Labs 10 Panel Dip Screen (BAR), Part No. APD-10M. The ArcPoint Labs Dip Drug Screen Dip Card is a one-step immunoassay for the qualitative detection of multiple drugs and drug metabolites in human urine.

    FDA Enforcement
    Class II ·Terminated·Ameditech Inc·October 22, 2014

    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