7 results
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12ms
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Sources: EU EUDAMED, US FDA
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Status: Terminated
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ConMed Laparoscopic Instrument: Meeker (Right Angle) Disposable Dissector, 5mm x 33cm length, REF/Product Code 60-6040-004. --- The product is distributed sterile in heat-sealed tray and labeled with an expiration date that pertains only to the sterility.
FDA Recall
Terminated
·Conmed Corporation·Product code GCJ·October 12, 2006
Respironics Trilogy 100, 200, and 202 Ventilators The Respironics Trilogy systems provides continuous or intermittent ventilatory support for the care of individuals who require mechanical ventilation. Trilogy 100 is intended for pediatric through adult patients weighing at least 5 kg (11 lbs.). The devices are intended to be used in home, institution/hospital, and portable applications such as wheelchairs and gurneys, and may be used for both invasive and non-invasive ventilation. They are not intended to be used as a transport ventilator.
FDA Enforcement
Class I
·Terminated·Respironics, Inc.·August 1, 2012
Viking M, L, and XL Mobile Lifts. Non-AC-powered patient lift.
FDA Enforcement
Class II
·Terminated·Hill-Rom, Inc.·June 24, 2015
Depuy brand ACE trochanteric nail; sterile, long, left hip, 340 x 13 x 130; Product 925213340.
FDA Recall
Terminated
·Depuy Orthopaedics, Inc.·Product code HSB·December 11, 2003
Liko Standard Slingbar 450. The Standard Slingbar 450 is a versatile sling bar which can be used for most lifting situations. It can be used with different Liko ceiling and mobile lifts.
FDA Enforcement
Class II
·Terminated·Hill-Rom, Inc.·January 9, 2013
Cannula and Seal; 5mm x 100mm and 12mm x 100mm Model #: CTS02 and CTS22. Indicated for use to establish a port of entry fro endoscopic instruments in patients requiring minimally invasive surgical procedures including thoracic, gynecologic laparoscopy and other abdominal procedures.
FDA Enforcement
Class II
·Terminated·Stryker Sustainability Solutions·July 1, 2015
Trilogy Ventilators The Respironics Trilogy 100 system provides continuous or intermittent ventilator support for the care of individuals who require mechanical ventilation. Trilogy 100 is intended for pediatric through adult patients weighing at least 5 kg (11 lbs.). The device is intended to be used in home, institution/hospital, and portable applications such as wheelchairs and gurneys, and may be used for both invasive and non-invasive ventilation. It is not intended to be used as a transport ventilator. Trilogy 200 Intended Use: The Respironics Trilogy 200 system provides continuous or intermittent ventilator support for the care of individuals who require mechanical ventilation. Trilogy 200 is intended for pediatric through adult patients weighing at least 5 kg (11 lbs.). The device is intended to be used in home, institution/hospital, and portable applications such as wheelchairs and gurneys, and may be used for both invasive and non-invasive ventilation. Trilogy 202 Intended Use: The Respironics Trilogy 202 system provides continuous or intermittent ventilator support for the care of individuals who require mechanical ventilation with or without air/oxygen blending. Trilogy 202 is intended for pediatric through adult patients weighing at least 5 kg (11 lbs.). The device is intended to be used in hospitals and institutions, and for portable applications such as wheelchairs and gurneys only when in an institutional setting. It may be used for both invasive and non-invasive ventilation. It is not intended to be used as a transport ventilator.
FDA Enforcement
Class I
·Terminated·Phillips Respironics, Inc.·March 12, 2014