BEUDAMED
    228 results · 14ms · Sources: EU EUDAMED, US FDA

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    #1 MAC F/O LARYNGOSCOPE; F/O Laryngoscope Set-MAC; F/O Laryngoscope Set-MAC W/LED

    FDA Enforcement
    Class II ·Terminated·Baxter Healthcare Corporation·July 6, 2022

    Rusch Greenlite MAC 1, Catalog Number 004551001. Used during tracheal intubation.

    FDA Enforcement
    Class II ·Terminated·Teleflex Medical·March 7, 2018

    MAC VU360, Electrocardiograph

    FDA Recall
    Terminated ·GE Healthcare, LLC·Product code DPS·October 27, 2020

    (1) ARROWg+ard Blue(R) MAC(TM) Two-Lumen Central Venous Access Kit for use with 7.5 - 8 Fr. Catheters, Product Number: ASK-21142-RH; (2) Arrowg+ard Blue(R) MAC(TM) Two-Lumen Central Venous Access Kit for use with 7 - 7.5 Fr. Catheters, Product Number: ASK-21242-MMC1; (3) ARROWg+ard Blue(R) MAC(TM) Two-Lumen Central Venous Access Kit for use with 7.5 - 8 Fr. Catheters, Product Number: ASK-21242-UCD; (4) ARROWg+ard Blue¿ MAC" Two-Lumen Central Venous Access Kit, Product Number: CDC-21242-1A; (5) ARROWg+ard Blue¿ PSI Kit, Product Number: CDC-29803-1A; (6) ARROWg+ard Blue¿ PSI Kit, Product Number: CDC-29903-1A

    FDA Enforcement
    Class II ·Terminated·Arrow International Inc·April 18, 2018

    GlideScope Titanium Single-Use Video Laryngoscope. It is a single-use video laryngoscope system (GlideScope Titanium System) consists of a sterile-packaged, single-use video laryngoscope, multi-use Smart Cable and portable GlideScope video monitor. The system incorporates a high-resolution, full-color digital camera and monitor for real-time viewing and recording. Affected Product Names and Part Numbers: -LoPro S3: 0574-0130 (single blade) or 0270-0769 (box of 10) -LoPro S4: 0574-0131 (single blade) or 0270-0770 (box of 10) -MAC S3: 0574-0132 (single blade) or 0270-0771 (box of 10) -MAC S4: 0574-0133 (single blade) or 0270-0772 (box of 10) The GlideScope Video Laryngoscopes are intended for use by qualified medical professionals to obtain a clear, unobstructed view of the vocal cords for medical procedures.

    FDA Enforcement
    Class I ·Terminated·Verathon, Inc.·March 16, 2016

    MAC VU360, Model Number 2030360-001, Electrocardiograph

    FDA Recall
    Terminated ·GE Healthcare, LLC·Product code DQK·June 28, 2019

    Mac Pin Non-Cannulated Screw, 6.5 x 60mm

    FDA Enforcement
    Class II ·Terminated·Amendia, Inc·January 17, 2018

    RUSCH, TruLite, One-Piece Disposable Laryngoscope Handle Blade Combination, Non-Sterile, Rx Only, Distributed by: Teleflex Medical.

    FDA Enforcement
    Class II ·Terminated·Teleflex Medical·August 6, 2014

    (1) ARROWg+ard Blue(R) MAC(TM) Two-Lumen Central Venous Access Kit for use with 7.5 - 8 Fr. Catheters, Product Number: ASK-21142-RH; (2) Arrowg+ard Blue(R) MAC(TM) Two-Lumen Central Venous Access Kit for use with 7 - 7.5 Fr. Catheters, Product Number: ASK-21242-MMC1; (3) ARROWg+ard Blue(R) MAC(TM) Two-Lumen Central Venous Access Kit for use with 7.5 - 8 Fr. Catheters, Product Number: ASK-21242-UCD; (4) ARROWg+ard Blue MAC" Two-Lumen Central Venous Access Kit, Product Number: CDC-21242-1A; (5) ARROWg+ard Blue PSI Kit, Product Number: CDC-29803-1A; (6) ARROWg+ard Blue PSI Kit, Product Number: CDC-29903-1A

    FDA Recall
    Terminated ·Arrow International Inc·Product code FOZ·December 22, 2017

    (1) MAC Two-Lumen Central Venous Access Kit for use with 7.5 - 8 Fr. Catheters, Product Number: ASK-11242-PHP; (2) Arrow¿ MAC" Two- Lumen Central Venous Access Kit, Product Number: CDC-11242-1A

    FDA Enforcement
    Class II ·Terminated·Arrow International Inc·April 18, 2018

    ARROWg+ard Blue MAC Two-Lumen Central Venous Access Kit. The MAC Two-Lumen Central Venous Access Device with ARROWg+ard Blue permits venous access and catheter introduction to the central circulation

    FDA Enforcement
    Class II ·Terminated·Arrow International Inc·June 14, 2017

    Arrow MAC Two-Lumen Central Venous Access Kit fr use with 7 - 7.5 Fr Catheters, REF ASK-11242-UPM1; catheter introducer

    FDA Enforcement
    Class I ·Terminated·ARROW INTERNATIONAL Inc.·December 21, 2022

    GE Healthcare MAC 800 RESTING ECG ANALYSIS SYSTEM. The MAC 800 is a portable EGG acquisition, analysis and recording system. The MAC 800 is intended to acquire, analyze, display and record information from adult and pediatric populations. Pediatric population is defined as patients between the ages of 0 and 15 years. The MAC 800 is intended to be used by trained operators in a hospital or medical professional's facility environment to record EGG signals from surface electrodes. The basic system shall provide 2 modes of operation: (I) Resting EGG mode and (2) Arrhythmia mode. The basic systems shall print 3, 6-leads of EGG. The device shall be upgradeable to provide software options such as 12-lead ECG measurement and interpretive analysis.

    FDA Recall
    Terminated ·GE Medical Systems, LLC·Product code DPS·December 10, 2009

    Crystal Metal Disposable Blades size Mac 4 (part number 50674, 50674/F, 50674/BMI) and Mac 3 (part numbers 50675, 50675/F, 50675/BMI) Product Usage: Disposable laryngoscope blades.

    FDA Recall
    Terminated ·Penlon, Ltd. Abingdon Science Park Barton Lane Abingdon United Kingdom·Product code CCW·September 21, 2011

    Mac Pin Non-Cannulated Screw, 6.5 x 60mm

    FDA Recall
    Terminated ·Amendia, Inc·Product code NKB·July 7, 2017

    Rusch Greenlite MAC 1, Catalog Number 004551001. Used during tracheal intubation.

    FDA Recall
    Terminated ·Teleflex Medical·Product code CCW·January 10, 2017

    1) ARROWg+ard Blue MAC Two-Lumen Central Venous Access Kit 2) ARROWg+ard Blue PSI Kit 3) ARROWg+ard Blue MAC Two-Lumen Central Venous Access Kit 4) ARROWg+ard Blue PSI Kit The MACTM two-Lumen Central Venous Access Device with ARROWg+ard Blue permits venous access and catheter introduction to the central circulation. It may be inserted into the jugular, subclavian, or femoral veins

    FDA Enforcement
    Class II ·Terminated·Arrow International Inc·June 21, 2017

    GE Medical Systems Mac-Lab System, cardiac catheterization data system. Software Version 6.5 2021423-015 Revision D GE Medical Systems, Information Technologies, Inc., 8200 West Tower Avenue, Milwaukee, WI 53223 USA.

    FDA Recall
    Terminated ·General Electric Medical Systems Information Technology·Product code DQK·February 16, 2007

    GE Healthcare Systems ComboLab System. Made up of both Mac-Lab System, Software Version 6.5 2021423-015 Revision D and CardioLab System, Software Version 6.5 2021423-016 Revision D. Electrophysiological data systems. GE Medical Systems, Information Technologies, Inc., 8200 West Tower Avenue, Milwaukee, WI 53223 USA

    FDA Recall
    Terminated ·General Electric Medical Systems Information Technology·Product code DQK·February 16, 2007

    McKesson Anesthesia Care Product Usage: The McKesson Anesthesia Care system is a computer based system which collects, processes,and records data both through manual entry and from monitors which themselves are attached to patients, such as in the operating room environment. The system provides clinical decision support by communicating potential Adverse Drug Event alerts proactively during the pre-anesthesia evaluation and at the point-of-care. The system is generally indicated in the anesthetizing environment when the anesthesia provider decides to perform a patient assessment, to generate a paper and/or electronic record of the administration of anesthesia to a patient, and to document care.

    FDA Enforcement
    Class I ·Terminated·MCKESSON TECHNOLOGIES INC.·March 12, 2014