BEUDAMED
    18 results · 49ms · Sources: EU EUDAMED, US FDA

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    AMT 12 inch Right Angle Feeding Set with Y-Port Used with Nasogastric/Nasointestinal (NG/NI) tubes.

    FDA Recall
    Terminated ·Applied Medical Technology Inc·Product code KNT·January 19, 2017

    AMT Bridle - Nasal Tube Retaining System Used with Nasogastric/Nasointestinal (NG/NI) tubes.

    FDA Recall
    Terminated ·Applied Medical Technology Inc·Product code KNT·January 19, 2017

    AMT Male ENFit-to-Stepped Male (Christmas Tree) Adapter, Model Number ETRN102. Box PN TRN102, Box UDI (01)00842071109066(17)230901(10)200918-103, Pouch PN ETRN102, Pouch UDI (01)00842071108007(17)230901(10)200902-075

    FDA Recall
    Terminated ·Applied Medical Technology Inc·Product code PIO·November 10, 2020

    Wilson Implantation System Product Usage: Indicated to aid in tissue retraction during a surgical procedure.

    FDA Recall
    Terminated ·Applied Medical Technology Inc·Product code GAD·February 17, 2016

    TLC Self Retaining Retractor System Contents 1-RETRACTOR FRAME 6-ELASTIC STAYS STERILE EO Rx ONLY Product Usage: Indicated to aid in tissue retraction during a surgical procedure.

    FDA Recall
    Terminated ·Applied Medical Technology Inc·Product code GAD·February 17, 2016

    AMT G-Jet Low-Profile Transgastric-Jejunal Feeding Device 14F 1.5cm 45cm SINGLE USE ONLY Rx ONLY STERILE. For use in patients who cannot absorb adequate nutrition through the stomach.

    FDA Recall
    Terminated ·Applied Medical Technology Inc·Product code KNT·January 26, 2016

    TLC Self-Retaining Retractor Frames SINGLE USE ONLY Rx ONLY (USA) STERILE EO Do Not Resterilize. Product Usage: Indicated to aid in tissue retraction during a surgical procedure.

    FDA Recall
    Terminated ·Applied Medical Technology Inc·Product code GAD·February 17, 2016

    Wilson Penile Implantation System Retractor Frame, Retractor Stays & Penile Elevation Strap, SINGLE USE ONLY Rx ONLY (USA) STERILE EO Do Not Resterilize Product Usage: Indicated to aid in tissue retraction during a surgical procedure.

    FDA Recall
    Terminated ·Applied Medical Technology Inc·Product code GAD·February 17, 2016

    TLC¿ Self Retaining Retractor System Contents 1-RETRACTOR FRAME 6-ELASTIC STAYS STERILE EO Rx ONLY Product Usage: Indicated to aid in tissue retraction during a surgical procedure.

    FDA Enforcement
    Class II ·Terminated·Applied Medical Technology Inc·May 11, 2016

    TLC¿ Self-Retaining Retractor Frames SINGLE USE ONLY Rx ONLY (USA) STERILE EO Do Not Resterilize. Product Usage: Indicated to aid in tissue retraction during a surgical procedure.

    FDA Enforcement
    Class II ·Terminated·Applied Medical Technology Inc·May 11, 2016

    Wilson Penile Implantation System Retractor Frame, Retractor Stays & Penile Elevation Strap, SINGLE USE ONLY Rx ONLY (USA) STERILE EO Do Not Resterilize Product Usage: Indicated to aid in tissue retraction during a surgical procedure.

    FDA Enforcement
    Class II ·Terminated·Applied Medical Technology Inc·May 11, 2016

    Wilson Implantation System Product Usage: Indicated to aid in tissue retraction during a surgical procedure.

    FDA Enforcement
    Class II ·Terminated·Applied Medical Technology Inc·May 11, 2016

    AMT Bridle - Nasal Tube Retaining System Used with Nasogastric/Nasointestinal (NG/NI) tubes.

    FDA Enforcement
    Class III ·Terminated·Applied Medical Technology Inc·March 1, 2017

    AMT 12 inch Right Angle Feeding Set with Y-Port Used with Nasogastric/Nasointestinal (NG/NI) tubes.

    FDA Enforcement
    Class III ·Terminated·Applied Medical Technology Inc·March 1, 2017

    AMT G-Jet¿ Low-Profile Transgastric-Jejunal Feeding Device 14F 1.5cm 45cm SINGLE USE ONLY Rx ONLY STERILE. For use in patients who cannot absorb adequate nutrition through the stomach.

    FDA Enforcement
    Class II ·Terminated·Applied Medical Technology Inc·April 20, 2016

    AMT Male ENFit-to-Stepped Male (Christmas Tree) Adapter, Model Number ETRN102. Box PN TRN102, Box UDI (01)00842071109066(17)230901(10)200918-103, Pouch PN ETRN102, Pouch UDI (01)00842071108007(17)230901(10)200902-075

    FDA Enforcement
    Class III ·Terminated·Applied Medical Technology Inc·December 30, 2020

    BIS Bilateral Sensors, part number 186-0212, packaged in boxes of 10. For use with BIS Monitoring System, Labeled as either Covidien Llc, or Aspect Medical Systems, Inc. Product Usage: To enable recordings of electrophysiological (such as EEG) signals. The Sensor is a single patient use, disposable, pre-gelled 6 electrode array that is applied directly to the patients forehead. BIS technology is used as an adjunct to clinical judgement and training. Reliance on BIS technology alone for intraoperative anesthetic management is not recommended.

    FDA Recall
    Terminated ·Nellcor Puritan Bennett Inc. (dba Covidien LP)·Product code GXY·November 8, 2011

    Enpath Lead Adapters, pacemaker lead adapter. Affects: 5 mm Bipolar, Model 501205; 6 mm Unipolar, Model 501204; 3.2 mm Low-Profile Bipolar Models 501206 and 501214. All labeled Sterile, EO, mail: Enpath Medical, Inc. Lead Technologies Division, Minneapolis, MN 55439 USA.

    FDA Recall
    Terminated ·Enpath Medical, Inc·Product code DTB·July 18, 2006