16 results
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37ms
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Sources: EU EUDAMED, US FDA
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Status: Terminated
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Siemens Mammomat Inspiration mammography systems. The Mammomat Inspiration system is intended for mammography exams, screening, diagnosis, and stereotactic biopsies under the supervision of medical professionals. Mammographic images can be interpreted by either hard copy film or soft copy workstation.
FDA Enforcement
Class II
·Terminated·Siemens Medical Solutions USA, Inc·October 29, 2014
Mammomat Inspiration system: Product Usage: mammography exams, screening, diagnosis, and stereotactic biopsies under the supervision of medical professionals. Mammographic images can be interpreted by either hard copy film or soft copy workstation.
FDA Enforcement
Class II
·Terminated·Siemens Medical Solutions USA, Inc·December 17, 2014
Mammomat Inspiration full, field digital,system,x-ray,mammographic Product Usage: The Mammomat Inspiration system is intended for mammography exams, screening, diagnosis, and stereotactic biopsies under the supervision of medical professionals. Mammographic images can be interpreted by either hard copy film or soft copy workstation.
FDA Enforcement
Class II
·Terminated·Siemens Medical Solutions USA, Inc·February 8, 2017
Siemens Mammomat Inspiration mammography systems. The Mammomat Inspiration system is intended for mammography exams, screening, diagnosis, and stereotactic biopsies under the supervision of medical professionals. Mammographic images can be interpreted by either hard copy film or soft copy workstation.
FDA Recall
Terminated
·Siemens Medical Solutions USA, Inc·Product code MUE·September 18, 2014
Varian Medical Systems Eclipse treatment planning system, Model Number H48, versions 6.5/7.x and Inspiration 8.0.
FDA Recall
Terminated
·Varian Medical Systems Oncology Systems·Product code IYE·November 21, 2008
Mammomat Inspiration full, field digital,system,x-ray,mammographic Product Usage: The Mammomat Inspiration system is intended for mammography exams, screening, diagnosis, and stereotactic biopsies under the supervision of medical professionals. Mammographic images can be interpreted by either hard copy film or soft copy workstation.
FDA Recall
Terminated
·Siemens Medical Solutions USA, Inc·Product code MUE·January 11, 2017
Inspire II Model 3024 Implantable Pulse Generator (IPG) for Obstructive Sleep Apnea, Inspire Part #900-003-020, Product Usage: The device is an implanted component of the Inspire Upper Airway Stimulation (UAS) system. The UAS therapy is used to treat a subset of patients with moderate to severe obstructive sleep apnea (OSA).
FDA Recall
Terminated
·Inspire Medical Systems Inc.·Product code MNQ·June 12, 2018
Inspiration Ventilator System, i Series and LS 12.1 LCD. The Inspiration 7i / 5i Ventilator System is to be used by healthcare professionals in hospitals or healthcare facilities and intra-hospital transport.
FDA Recall
Terminated
·Event Medical LTD·Product code CBK·October 13, 2015
Inspire II Model 3024 Implantable Pulse Generator (IPG) for Obstructive Sleep Apnea, Inspire Part #900-003-020, Product Usage: The device is an implanted component of the Inspire Upper Airway Stimulation (UAS) system. The UAS therapy is used to treat a subset of patients with moderate to severe obstructive sleep apnea (OSA).
FDA Enforcement
Class II
·Terminated·Inspire Medical Systems Inc.·September 12, 2018
Mammomat Inspiration system: Product Usage: mammography exams, screening, diagnosis, and stereotactic biopsies under the supervision of medical professionals. Mammographic images can be interpreted by either hard copy film or soft copy workstation.
FDA Recall
Terminated
·Siemens Medical Solutions USA, Inc·Product code MUE·October 28, 2014
Ikaria INOMAX DS Drug Delivery System, model 10003. Ikaria 6 Route 173, Clinton, NJ 08809 USA. The INOMAX DS Delivery System delivers INOMAX (nitric oxide for inhalation) therapy gas into the inspiratory limb of the patient breathing circuit in a way that provides a constant concentration of nitric oxide (NO), as set by the user, to the patient throughout the inspired breath. It uses a specially designed injector module, which enables tracking of the ventilator waveforms and the delivery of a synchronized and proportional dose of NO. It may be used with most ventilators. The INOMAX DS provides continuous integrated monitoring of inspired O2, NO2, and NO, and a comprehensive alarm system.
FDA Recall
Terminated
·Ikaria Holdings·Product code MRN·July 21, 2010
Datascope AS3000 Anesthesia System; Mindray, North America. The AS3000 Anesthesia Delivery System is a continuous flow inhalation gas anesthesia system that delivers anesthetic vapor, provides for automatic and manual modes of ventilation, and is equipped with a monitoring system for ventilation, inspired and expired gas. The AS3000 is intended for use in operating rooms. It is used with O2, N2O and AIR supplied by a medical gas pipeline system or by externally mounted gas cylinders. Anesthetic agent can be delivered via vaporizers mounted on the machine.
FDA Recall
Terminated
·Mindray DS USA, Inc., dba Datascope Patient Monitoring·Product code BSZ·March 5, 2010
MAMMOMAT Inspiration Full field digital mammographic x-ray system
FDA Recall
Terminated
·Siemens Medical Solutions USA, Inc·Product code MUE·September 15, 2011
The 91220 mCare 300 Vital Signs monitor has a 10.4 inch resistive touchscreen display. The Spacelabs Medical, mCare 300, Model 91220, Vital Signs Monitor is a compact monitoring system with a resistive touchscreen display. It is indicated for use in adult, pediatric and neonate patient populations wherever there is a need for the monitoring of ECG, respiration, invasive or noninvasive blood pressures, body temperature, functional arterial oxygen saturation, or expired or minimum inspire CO2. The product is a prescription device intended to be used by healthcare professionals in all areas of a healthcare facility.
FDA Recall
Terminated
·Spacelabs Healthcare, Incorporated·Product code MHZ·April 14, 2010
The Tri-Flo Subglottic Suction System
FDA Enforcement
Class I
·Terminated·Vyaire Medical·August 29, 2018
The Tri-Flo Subglottic Suction System
FDA Recall
Terminated
·Vyaire Medical·Product code BSY·June 20, 2018