BEUDAMED
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    The GLOBAL UNITE Platform Shoulder System is intended for cemented or uncemented total shoulder or hemi-shoulder replacement procedures, Product labeling: LEO-1100-30-000 REV D.pdf.pdf, LEO-1100-40-000 REV D.pdf.pdf, LEO-110030100_REV D.pdf.pdf, LEO-110030110_REV D.pdf.pdf, LEO-110030120_REV D.pdf.pdf

    FDA Recall
    Terminated ·DePuy Orthopaedics, Inc.·Product code KWS·November 28, 2017

    The GLOBAL UNITE Platform Shoulder System is intended for cemented or uncemented total shoulder or hemi-shoulder replacement procedures, Product labeling: LE¿O-1100-30-000 REV D.pdf.pdf, LE¿O-1100-40-000 REV D.pdf.pdf, LE¿O-110030100_REV D.pdf.pdf, LE¿O-110030110_REV D.pdf.pdf, LE¿O-110030120_REV D.pdf.pdf

    FDA Enforcement
    Class II ·Terminated·DePuy Orthopaedics, Inc.·March 21, 2018

    Leo 3-Wheel Scooter and Leo Scooter, Distributed By: Invacare Corporation, 1200 Taylor Street, Elyria, OH 44035 Intended to provide transportation for a disabled or elderly person.

    FDA Recall
    Terminated ·Invacare Corporation·Product code INI·December 7, 2011

    EPIDURAL CATHETERIZATION KIT, Product Code AT-05501-LEO

    FDA Recall
    Terminated ·Arrow International Inc·Product code CAZ·January 15, 2020

    EPIDURAL CATHETERIZATION KIT, Product Code AT-05501-LEO

    FDA Enforcement
    Class II ·Terminated·Arrow International Inc·February 19, 2020

    Alinity m SARS-CoV-2 Amp Kit (Non-US Assay) and Alinity m SARS-CoV-2 Application Specification File. in vitro diagnostic

    FDA Enforcement
    Class I ·Terminated·Abbott Molecular, Inc.·October 20, 2021

    Alinity m Resp-4-Plex AMP Kit (Emergency Use Authorization, US Assay) and Alinity m Resp-4-Plex Application Specification File. in vitro diagnostic

    FDA Enforcement
    Class I ·Terminated·Abbott Molecular, Inc.·October 20, 2021

    Alinity m Resp-4-Plex AMP Kit (Non-US Assay) and Alinity m Resp-4-Plex Application Specification File. in vitro diagnostic

    FDA Enforcement
    Class I ·Terminated·Abbott Molecular, Inc.·October 20, 2021

    Visaris Vision/Auto, ddRAura OTC APS, Diagnostic X-Ray System, Version 2.2 The Vision systems are intended for use in all areas of diagnostic radiography imaging and specifically at secondary and tertiary levels of medical care. Powerful positioning capability makes this system particularly suited for institutions with immobile or hardly mobile patients, such as trauma wards and emergency departments. The system s versatility also makes it suitable for unified diagnostic imaging services for medium size hospitals where this system can cover all diagnostic radiography needs. In general, Vision systems are intended to position the patient, x-ray source and digital detector in such a way as to expose only the desired patient anatomy to X-rays and capture the resulting x-ray image. They are then intended to process the acquired image to a diagnostic viewing level and export it in DICOM format through an option of several distribution media including film, paper, CD-DVD and digital PACS archives. The system is intended for routine, daily, dedicated use in radiographic diagnosis. It can be used in any type of specialized radiology wards or for general radiographic diagnostics

    FDA Enforcement
    Class II ·Terminated·Visaris DOO·May 23, 2018

    Visaris Vision/Auto, ddRAura OTC APS, Diagnostic X-Ray System, Version 2.4 The Vision systems are intended for use in all areas of diagnostic radiography imaging and specifically at secondary and tertiary levels of medical care. Powerful positioning capability makes this system particularly suited for institutions with immobile or hardly mobile patients, such as trauma wards and emergency departments. The system s versatility also makes it suitable for unified diagnostic imaging services for medium size hospitals where this system can cover all diagnostic radiography needs. In general, Vision systems are intended to position the patient, x-ray source and digital detector in such a way as to expose only the desired patient anatomy to X-rays and capture the resulting x-ray image. They are then intended to process the acquired image to a diagnostic viewing level and export it in DICOM format through an option of several distribution media including film, paper, CD-DVD and digital PACS archives. The system is intended for routine, daily, dedicated use in radiographic diagnosis. It can be used in any type of specialized radiology wards or for general radiographic diagnostics

    FDA Enforcement
    Class II ·Terminated·Visaris DOO·May 23, 2018

    Visaris Vision/Auto, ddRAura OTC APS, Diagnostic X-Ray System, Version 2.3 The Vision systems are intended for use in all areas of diagnostic radiography imaging and specifically at secondary and tertiary levels of medical care. Powerful positioning capability makes this system particularly suited for institutions with immobile or hardly mobile patients, such as trauma wards and emergency departments. The system s versatility also makes it suitable for unified diagnostic imaging services for medium size hospitals where this system can cover all diagnostic radiography needs. In general, Vision systems are intended to position the patient, x-ray source and digital detector in such a way as to expose only the desired patient anatomy to X-rays and capture the resulting x-ray image. They are then intended to process the acquired image to a diagnostic viewing level and export it in DICOM format through an option of several distribution media including film, paper, CD-DVD and digital PACS archives. The system is intended for routine, daily, dedicated use in radiographic diagnosis. It can be used in any type of specialized radiology wards or for general radiographic diagnostics

    FDA Enforcement
    Class II ·Terminated·Visaris DOO·May 23, 2018

    Alinity m SARS-CoV-2 Amp Kit (Emergency Use Authorization, US Assay) and Alinity m SARS-CoV-2 Application Specification File. in vitro diagnostic

    FDA Enforcement
    Class I ·Terminated·Abbott Molecular, Inc.·October 20, 2021

    Alinity m SARS-CoV-2 Amp Kit (Non-US Assay) and Alinity m SARS-CoV-2 Application Specification File. in vitro diagnostic

    FDA Enforcement
    Class I ·Terminated·Abbott Molecular, Inc.·October 20, 2021

    Hermes NC PTA Balloon Dilatation Catheter The balloon dilatation catheter is intended to dilate stenoses in the iliac, femoral, iliofemoral, popliteal, infrapopliteal, and renal arteries, and for the treatment of obstructive lesions of native or synthetic arteriovenous dialysis fistulae. This device is also indicated for stent dilatation post-deployment in the peripheral vasculature.

    FDA Recall
    Terminated ·BrosMed Medical Co., Ltd. Bubugaogaofu Lou Lou 15th Songshan Lake Hi Dongguan China·Product code LIT·December 14, 2018

    Vaporizer Plate Vaporizer Plate Consumable accessory used with the STERRAD 100 and the STERRAD 100S

    FDA Recall
    Terminated ·Advanced Sterilization Products·Product code MLR·September 16, 2005

    BD 1 ml Integra TB Syringe with Retracting Precision Glide Needle; 1 ml 27 g 1/2 (0.4mm x 13 mm); Sterile; REF # 305298 BD, Franklin Lakes, NJ 07417. Made in USA Syringes for use in aspiration and injection of medications.

    FDA Recall
    Terminated ·Becton Dickinson & Company·Product code MEG·November 24, 2008

    AirLife Resuscitation, Replacement kit for outer shell, Broselow Product Usage: The AirLife Resuscitation devices are manual resuscitation devices that are used to provide positive pressure ventilation to patients who are not breathing or cannot adequately breathe on their own.

    FDA Recall
    Terminated ·Vyaire Medical·Product code OEV·April 27, 2017

    AirLife Resuscitation, Pediatric, with mask, oxygen reservoir bag, pressure-relief valve, PEEP valve Product Usage: The AirLife Resuscitation devices are manual resuscitation devices that are used to provide positive pressure ventilation to patients who are not breathing or cannot adequately breathe on their own.

    FDA Recall
    Terminated ·Vyaire Medical·Product code OEV·April 27, 2017

    AirLife Resuscitation, Adult, with mask, oxygen reservoir bag, manometer, PEEP valve Product Usage: The AirLife Resuscitation devices are manual resuscitation devices that are used to provide positive pressure ventilation to patients who are not breathing or cannot adequately breathe on their own.

    FDA Recall
    Terminated ·Vyaire Medical·Product code OEV·April 27, 2017

    AirLife Resuscitation, Adult, with mask, oxygen reservoir bag, CO2 detector Product Usage: The AirLife Resuscitation devices are manual resuscitation devices that are used to provide positive pressure ventilation to patients who are not breathing or cannot adequately breathe on their own.

    FDA Recall
    Terminated ·Vyaire Medical·Product code OEV·April 27, 2017