4 results
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50ms
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Sources: EU EUDAMED, US FDA
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Status: Terminated
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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
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 Full field digital mammographic x-ray system
FDA Recall
Terminated
·Siemens Medical Solutions USA, Inc·Product code MUE·September 15, 2011
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