BEUDAMED
    140 results · 19ms · Sources: EU EUDAMED, US FDA

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    740 Series Multiparameter Monitor Software Version 3.0 Model Numbers: 740-1, 740M-1, 740-2T, 740M-2T, 740-2MS, 740M-2MS, 740-2NL, 740M-2NL, 740-2NN, 740M-2NN, 740-3MS, 740M-3MS, 740-3NL, 740M-3NL, 740-3NN, and 740M-3NN CAS Medical Systems, Inc., Branford, Connecticut 06405 Indicated for use for non-invasive monitoring of blood pressure, oxygen saturation, pulse and temperature of adults, pediatric and neonatal patients, in the care of health professionals.

    FDA Recall
    Terminated ·CAS Medical Systems, Inc.·Product code MHX·June 24, 2008

    ANSPACH - 2.3MM Fluted Matchstick, Extends 22MM; REF S-8N-L-G1 Cutting shaping bone including spine and cranium.

    FDA Enforcement
    Class II ·Terminated·The Anspach Effort, Inc.·August 5, 2015

    ANSPACH - 2.3MM Fluted Matchstick, Extends 22MM; REF S-8N-L-G1 Cutting shaping bone including spine and cranium.

    FDA Recall
    Terminated ·The Anspach Effort, Inc.·Product code HBE·April 13, 2015

    The GlideScope Video Laryngoscope (GVL) is a video laryngoscope that incorporates a high-resolution color camera, an LED light source, a rechargeable lithium battery, and video output to a remote monitor. It consists of a video laryngoscope and a portable video monitor. The affected GVL and Part numbers are GVL 3  0574-0007, GVL 4  0574-0001, and GVL 5  0574-0030. 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.·December 19, 2012

    GlideScope Video Laryngoscope Reusable Blades (GVL 3, 4, 5 and AVL 2, 3, 4, 5). GVL: The GlideScope Video Laryngoscope is a video laryngoscope that incorporates a high-resolution color camera, an LED light source, a rechargeable lithium battery, and video output to a remote monitor. It consists of a video laryngoscope and a portable video monitor. AVL: The GlideScope AVL Video Monitor system has the same intended use as the GVL System. The difference between systems is that the AVL has a digital platform and the GVL an analog platform.

    FDA Enforcement
    Class II ·Terminated·Verathon, Inc.·February 24, 2016

    GlideScope AVL Video Laryngoscope (AVL), Part Number AVL 3- 0574-0115; AVL 4-0574-0116, AVL 5- 0574-0117. AVL is a video laryngoscope that incorporates a high resolution color camera, an LED light source and video output to a remote monitor. This system has a digital platform.

    FDA Enforcement
    Class II ·Terminated·Verathon, Inc.·December 23, 2015

    GlideScope Video Laryngoscope (GVL), Part Number GVL 3 - 0574-0007; GVL 4 - 0574-0001; GVL 5- 0574-0030. The system consists of a video laryngoscope and portable video monitor. 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. GVL is a video laryngoscope that incorporates a high resolution color camera, an LED light source and video output to a remote monitor.

    FDA Enforcement
    Class II ·Terminated·Verathon, Inc.·December 23, 2015

    Stryker Epic Critical Care Bed; Model 2030.

    FDA Recall
    Terminated ·Stryker Medical·Product code FNL·January 17, 2006

    Stryker Secure II hospital bed; model 3002.

    FDA Recall
    Terminated ·Stryker Medical·Product code FNL·May 1, 2003

    Low-Boy Bed, AC-powered adjustable hospital bed with a low position of 7'' to a high position of 30''. The beds are distributed by SIZEWise Rentals, Ellis, KS.

    FDA Recall
    Terminated ·Rayes Inc·Product code FNL·November 14, 2005

    Joerns Easy Care 2003 bed, Model B684; Joerns Easy Care 2003 DC bed, Model B684DC; Joerns Easy Care 2100, Model B694 AC-powered adjustable Hospital Beds

    FDA Recall
    Terminated ·Sunrise Medical CCG, Inc.·Product code FNL·November 16, 2005

    Stryker Secure II MedSurg bed, 230 v, Stryker Medical, Portage, MI; Model 3221. (Note: Not distributed in the US) Beds are A/C powered hospital beds that are intended for medical purposes within the hospital setting.

    FDA Recall
    Terminated ·Stryker Medical Div. of Stryker Corporation·Product code FNL·August 10, 2009

    Stryker Epic II critical care bed, 230v, Stryker Medical, Portage, MI; Model 2031. (Note: This product is not sold in the US). Beds are A/C powered hospital beds that are intended for medical purposes within the hospital setting.

    FDA Recall
    Terminated ·Stryker Medical Div. of Stryker Corporation·Product code FNL·August 10, 2009

    Stryker Zoom critical care bed, 115v, Stryker Medical, Portage, MI; Model 2040. Beds are A/C powered hospital beds that are intended for medical purposes within the hospital setting.

    FDA Recall
    Terminated ·Stryker Medical Div. of Stryker Corporation·Product code FNL·August 10, 2009

    Stryker Medical Secure II Med/Surg Bed, 230 V, Stryker Medical, Portage, MI.; Model 3221 (not sold in the U.S.).

    FDA Recall
    Terminated ·Stryker Medical Div. of Stryker Corporation·Product code FNL·February 1, 2008

    Enterprise 9000 Bed; an AC-powered adjustable hospital bed with built-in electronic weigh scale, patient bed exit alarm, and under bed anti-entrapment system; ArjoHuntleigh AB, Eslov, Sweden; Models 9000, 9600, 9700 and 9800 General medicine, general and specialist surgery, care of the elderly, HDU, ITU, coronary care and oncology. The bed is appropriate for high dependency patients who pose a movement and handling risk and/or whose clinical condition requires that they are positioned with the minimal physical handling.

    FDA Recall
    Terminated ·Arjo, Inc. dba ArjoHuntleigh·Product code FNL·November 16, 2012

    Hill-Rom 1000 bed model P1160.

    FDA Recall
    Terminated ·Hill-Rom, Inc. 125 E Pearl St 1069 State Route 46 East Batesville IN 47006·Product code FNL·April 13, 2009

    Stryker Epic Zoom Critical Care Bed; Model 2040.

    FDA Recall
    Terminated ·Stryker Medical·Product code FNL·January 17, 2006

    Stryker MedSurg bed, 115v, Stryker Medical, Portage, MI; Model 3002 S3. Beds are A/C powered hospital beds that are intended for medical purposes within the hospital setting.

    FDA Recall
    Terminated ·Stryker Medical Div. of Stryker Corporation·Product code FNL·August 10, 2009

    Vail 500 Enclosed Bed System.

    FDA Recall
    Terminated ·Vail Products Inc·Product code FNL·May 6, 2005