BEUDAMED
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    WMTS Telemetry Receiver, Multiple Patient Receiver, Model Number/ UDI: ORG 9100A/ 00841983102554 ORG 9110A/ 00841983102561 ORG 9700A/No UDI

    FDA Recall
    Open, Classified ·Nihon Kohden America Inc·Product code DRG·January 8, 2021

    BioButton REF BIOST06040 with Software version 3.0.20 The BioButton System is a remote monitoring wearable device intended for continuous collection of physiological data in home and healthcare settings while the patient is at rest.

    FDA Recall
    Open, Classified ·Biointellisense Inc. 570 El Camino Real·Product code DRG·July 19, 2024

    SurgASSIST System. Circular Stapler DLU 33 mm (product code CS33).

    FDA Recall
    Terminated ·Power Medical Interventions·Product code GAG·June 30, 2003

    Lithium Thionyl non-rechargeable disposable battery pack P/N 350-0294-00 used with ER920 Wireless Series Arrhythmia Event Recorder. Non-rechargeable disposable battery pack.

    FDA Recall
    Terminated ·BRAEMAR, INC.·Product code DRG·May 2, 2011

    EEA Circular Stapler with Tri-Staple Technology, Part No. TRIEEA28MT TRIEEA28XT TRIEEA31MT TRIEEA31XT Product Usage: The EEA Circular Stapler with Tri-Staple Technology places a circular, triple staggered row of titanium staples and resects the excess tissue, creating a circular anastomosis.

    FDA Recall
    Terminated ·COVIDIEN LLC·Product code GAG·August 17, 2018

    Turbett Surgical Container, TS1500

    FDA Recall
    Terminated ·Turbett Surgical, Inc.·Product code FRG·April 14, 2022

    Vis-U-All High Temperature Tubing 6"x100'. One roll per box; 10 boxes per case 10 rolls/cs Product Usage: The Vis-U-All High Temperature Sterilization Pouch is suitable for use by healthcare providers to enclose and seal medical devices to be sterilized by steam. The pouch is designed to maintain sterility of properly processed medical devices during normal handling and storage until the pouch is opened and the medical device is removed for use.

    FDA Recall
    Terminated ·Steris Corporation·Product code FRG·June 15, 2017

    Vis-U-All High Temp 3.5"x9" Self Seal Pouch 200 pouches per box; 4 boxes per case Product Usage: The Vis-U-All High Temperature Sterilization Pouch is suitable for use by healthcare providers to enclose and seal medical devices to be sterilized by steam. The pouch is designed to maintain sterility of properly processed medical devices during normal handling and storage until the pouch is opened and the medical device is removed for use.

    FDA Recall
    Terminated ·Steris Corporation·Product code FRG·June 15, 2017

    Vis-U-All High Temp 3.5"x22" Self Seal Pouch 200 pouches per box; 4 boxes per case Product Usage: The Vis-U-All High Temperature Sterilization Pouch is suitable for use by healthcare providers to enclose and seal medical devices to be sterilized by steam. The pouch is designed to maintain sterility of properly processed medical devices during normal handling and storage until the pouch is opened and the medical device is removed for use.

    FDA Recall
    Terminated ·Steris Corporation·Product code FRG·June 15, 2017

    daVinci XI Sureform 60 reload, 60 mm Green 6- Row, 4.6 mm, REF 48360G-08, UDI: 00886874113844, Rx Only, Sterile EO - Product Usage: are intended to be used with da Vinci Surgical Systems for resection, transection, and, or creation of anastomoses in General, Thoracic, Gynecologic, Urologic, and Pediatric surgery.

    FDA Recall
    Open, Classified ·Intuitive Surgical, Inc.·Product code GAG·July 1, 2019

    Vis-U-All High Temp 3.5"x9" Self Seal Pouch 200 pouches per box; 4 boxes per case Model Number: 884039

    FDA Recall
    Terminated ·Steris Corporation·Product code FRG·December 2, 2020

    Turbett Surgical Container, TS1000: Indicated for enclosing other medical devices that are to be sterilized by a healthcare provider

    FDA Recall
    Open, Classified ·Turbett Surgical, Inc.·Product code FRG·December 5, 2022

    Turbett Surgical Container, TS1200: Indicated for enclosing other medical devices that are to be sterilized by a healthcare provider

    FDA Recall
    Open, Classified ·Turbett Surgical, Inc.·Product code FRG·December 5, 2022

    Turbett Surgical Container, TS1500

    FDA Recall
    Open, Classified ·TURBETT SURGICAL, LLC·Product code FRG·April 1, 2022

    LS-202 Large LeadWear Combo Pack - Disposable ECG Monitoring component intended for use as a radiofrequency signal transmitter and receiver of electrocardiograph physiological signals which are displayed on the ECG monitors of various manufacturers' systems that have been validated for compatibility.

    FDA Recall
    Terminated ·Lifesync Corporation·Product code DRG·December 13, 2007

    daVinci XI Sureform 60 Reload, 60 mm black 6-Row 4.6 mm, Ref: 48360T-08 , UDI: 00886874113851, Rx only, SterileEO - Product Usage: are intended to be used with da Vinci Surgical Systems for resection, transection, and, or creation of anastomoses in General, Thoracic, Gynecologic, Urologic, and Pediatric surgery.

    FDA Recall
    Open, Classified ·Intuitive Surgical, Inc.·Product code GAG·July 1, 2019

    Vis-U-All High Temp 18"x22" Heat Seal Pouch 100 pouches per box; 5 boxes per case Product Usage: The Vis-U-All High Temperature Sterilization Pouch is suitable for use by healthcare providers to enclose and seal medical devices to be sterilized by steam. The pouch is designed to maintain sterility of properly processed medical devices during normal handling and storage until the pouch is opened and the medical device is removed for use.

    FDA Recall
    Terminated ·Steris Corporation·Product code FRG·June 15, 2017

    Vis-U-All High Temp 13"x18" Heat Seal Pouch 100 pouches per box; 4 boxes per case Product Usage: The Vis-U-All High Temperature Sterilization Pouch is suitable for use by healthcare providers to enclose and seal medical devices to be sterilized by steam. The pouch is designed to maintain sterility of properly processed medical devices during normal handling and storage until the pouch is opened and the medical device is removed for use.

    FDA Recall
    Terminated ·Steris Corporation·Product code FRG·June 15, 2017

    Vis-U-All High Temp 18"x22" Self Seal Pouch 100 pouches per box; 5 boxes per case Product Usage: The Vis-U-All High Temperature Sterilization Pouch is suitable for use by healthcare providers to enclose and seal medical devices to be sterilized by steam. The pouch is designed to maintain sterility of properly processed medical devices during normal handling and storage until the pouch is opened and the medical device is removed for use.

    FDA Recall
    Terminated ·Steris Corporation·Product code FRG·June 15, 2017

    Vis-U-All High Temperature Tubing 4"x100'. One roll per box; 10 boxes per case 10 rolls/cs Product Usage: The Vis-U-All High Temperature Sterilization Pouch is suitable for use by healthcare providers to enclose and seal medical devices to be sterilized by steam. The pouch is designed to maintain sterility of properly processed medical devices during normal handling and storage until the pouch is opened and the medical device is removed for use.

    FDA Recall
    Terminated ·Steris Corporation·Product code FRG·June 15, 2017