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    A2613 SPINAL(FL)W/DRUGS

    FDA Recall
    Terminated ·Smiths Medical ASD, Inc.·Product code CAZ·July 2, 2004

    A2654-24 SPINAL (FL) W/DRUGS

    FDA Recall
    Terminated ·Smiths Medical ASD, Inc.·Product code CAZ·July 2, 2004

    FACE PACK FJG 8/CS Used by medical staff to perform surgical procedures and patient care procedures such as wound healing, suture removals, irrigate wounds, etc. .

    FDA Recall
    Terminated ·Customed, Inc Calle Igualdad Final # 7·Product code LRO·July 10, 2015

    TUMMY TUCK PACK-FJG 6/CS Used by medical staff to perform surgical procedures and patient care procedures such as wound healing, suture removals, irrigate wounds, etc. .

    FDA Recall
    Terminated ·Customed, Inc Calle Igualdad Final # 7·Product code LRO·July 10, 2015

    Leksell Gamma Knife Perfexion, Article #715000. Teletherapy device intended for stereotactic irradiation of head structures ranging from very small target sizes of a few millimeters to several centimeters.

    FDA Recall
    Terminated ·Elekta, Inc.·Product code IWB·July 2, 2007

    Radionuclide Radiation Therapy System Product The product is a teletherapy device intended for stereotactic irradiation of head structures ranging from very small target sizes of a few millimeters to several centimeters.

    FDA Recall
    Terminated ·Elekta, Inc.·Product code IWB·April 19, 2016

    Leksell Gamma Knife Perfexion, Product Number: 715000. Radionuclide radiation therapy system. Elekta, Inc. Norcross, GA. Intended for stereotactic irradiation of head structures ranging from very small target sizes of a few millimeters to several centimeters.

    FDA Recall
    Terminated ·Elekta, Inc.·Product code IWB·November 6, 2009

    Leksell Gamma Knife Perfexion, Radionuclide radiation therapy system. Article Number 715000, Elekta, Inc. Norcross, GA 30092. Teletherapy device intended for stereotactic irradiation of head structures ranging from very small target sized os a few millimeters to several centimeters.

    FDA Recall
    Terminated ·Elekta, Inc.·Product code IWB·November 9, 2008

    BYTE Aligner System REF PRS-0063 BYTE All-Day Aligner System BYTE AT-Night Aligner System A custom-made orthodontic appliance, typically supplied in series intended to be worn in succession and self-changed every few weeks, designed to influence the shape and/or function of the stomatognathic system to correct malocclusions.

    FDA Recall
    Open, Classified ·Straight Smile, LLC·Product code NXC·November 4, 2024

    Mach 1 6F Kimny Guide Catheter. Catalog No. 34356-583. Sterilized with ethylene oxide gas. Nonpyrogenic. Intended for one procedure use only. Manufacturer: Boston Scientific Scimed, Inc., One Scimed Place, Maple Grove, MN USA 55311.

    FDA Recall
    Terminated ·Boston Scientific Scimed·Product code DQY·May 24, 2004

    Mach 1 6F JR 3.5 Guide Catheter. Catalog No. 34356-685. Sterilized with ethylene oxide gas. Nonpyrogenic. Intended for one procedure use only. Manufacture: Boston Scientific Scimed, Inc., One Scimed Place, Maple Grove, MN USA 55311

    FDA Recall
    Terminated ·Boston Scientific Scimed·Product code DQY·May 24, 2004

    Medtronic InSync Marquis, model 7277 Dual Chamber Implantable Cardioverter Defibrillator (ICD) with Cardiac Resynchronization Therapy devices are tiered therapy implantable arrhythmia control devices, which provide automatic detection of ventricular arrhythmias and delivery of user-selected therapies for the detected arrhythmia. Therapies are automatically delivered following detection or can be initiated via programming by the physician. These ICDs are multi-programmable and have the capability of transmitting via telemetry the programmed values, measured and collected data, and event markers.

    FDA Recall
    Terminated ·Medtronic Inc. Cardiac Rhythm Managment·Product code NIK·February 9, 2005

    Medtronic Maximo VR, model 7232 Single Chamber Implantable Cardioverter Defibrillator (ICD)devices are tiered therapy implantable arrhythmia control devices, which provide automatic detection of ventricular arrhythmias and delivery of user-selected therapies for the detected arrhythmia. Therapies are automatically delivered following detection or can be initiated via programming by the physician. These ICDs are multi-programmable and have the capability of transmitting via telemetry the programmed values, measured and collected data, and event markers.

    FDA Recall
    Terminated ·Medtronic Inc. Cardiac Rhythm Managment·Product code LWS·February 9, 2005

    Medtronic Marquis VR, model 7230 Single Chamber Implantable Cardioverter Defibrillator (ICD)devices are tiered therapy implantable arrhythmia control devices, which provide automatic detection of ventricular arrhythmias and delivery of user-selected therapies for the detected arrhythmia. Therapies are automatically delivered following detection or can be initiated via programming by the physician. These ICDs are multi-programmable and have the capability of transmitting via telemetry the programmed values, measured and collected data, and event markers.

    FDA Recall
    Terminated ·Medtronic Inc. Cardiac Rhythm Managment·Product code LWS·February 9, 2005

    Medtronic Marquis DR, model 7274 Dual Chamber Implantable Cardioverter Defibrillator (ICD) devices are tiered therapy implantable arrhythmia control devices, which provide automatic detection of ventricular arrhythmias and delivery of user-selected therapies for the detected arrhythmia. Therapies are automatically delivered following detection or can be initiated via programming by the physician. These ICDs are multi-programmable and have the capability of transmitting via telemetry the programmed values, measured and collected data, and event markers.

    FDA Recall
    Terminated ·Medtronic Inc. Cardiac Rhythm Managment·Product code LWS·February 9, 2005

    Medtronic InSync II Marquis, model 7289 Dual Chamber Implantable Cardioverter Defibrillator (ICD) with Cardiac Resynchronization Therapy devices are tiered therapy implantable arrhythmia control devices, which provide automatic detection of ventricular arrhythmias and delivery of user-selected therapies for the detected arrhythmia. Therapies are automatically delivered following detection or can be initiated via programming by the physician. These ICDs are multi-programmable and have the capability of transmitting via telemetry the programmed values, measured and collected data, and event markers.

    FDA Recall
    Terminated ·Medtronic Inc. Cardiac Rhythm Managment·Product code NIK·February 9, 2005

    Medtronic Maximo DR, model 7278 Single Chamber Implantable Cardioverter Defibrillator (ICD)devices are tiered therapy implantable arrhythmia control devices, which provide automatic detection of ventricular arrhythmias and delivery of user-selected therapies for the detected arrhythmia. Therapies are automatically delivered following detection or can be initiated via programming by the physician. These ICDs are multi-programmable and have the capability of transmitting via telemetry the programmed values, measured and collected data, and event markers.

    FDA Recall
    Terminated ·Medtronic Inc. Cardiac Rhythm Managment·Product code LWS·February 9, 2005

    Medtronic InSync III Marquis, model 7279 Dual Chamber Implantable Cardioverter Defibrillator (ICD) with Cardiac Resynchronization Therapy devices are tiered therapy implantable arrhythmia control devices, which provide automatic detection of ventricular arrhythmias and delivery of user-selected therapies for the detected arrhythmia. Therapies are automatically delivered following detection or can be initiated via programming by the physician. These ICDs are multi-programmable and have the capability of transmitting via telemetry the programmed values, measured and collected data, and event markers.

    FDA Recall
    Terminated ·Medtronic Inc. Cardiac Rhythm Managment·Product code NIK·February 9, 2005

    Medtronic InSync III Protect, model 7285 Dual Chamber Implantable Cardioverter Defibrillator (ICD) with Cardiac Resynchronization Therapy devices are tiered therapy implantable arrhythmia control devices, which provide automatic detection of ventricular arrhythmias and delivery of user-selected therapies for the detected arrhythmia. Therapies are automatically delivered following detection or can be initiated via programming by the physician. These ICDs are multi-programmable and have the capability of transmitting via telemetry the programmed values, measured and collected data, and event markers.

    FDA Recall
    Terminated ·Medtronic Inc. Cardiac Rhythm Managment·Product code NIK·February 9, 2005

    daVinci Harmonic ACE Curved Shears

    FDA Recall
    Open, Classified ·Intuitive Surgical, Inc.·Product code NAY·January 16, 2019