2,394 results
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25ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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REMSTAR AUTO A-FLEX, SYS ONE, 60 SRS,GER
FDA Adverse Event
Injury
·RESPIRONICS, INC.·Product code BZD·October 5, 2021
REMSTAR AUTO A-FLEX, SYS ONE, 60 SRS,GER
FDA Adverse Event
Injury
·RESPIRONICS INC·Product code BZD·August 30, 2021
REMSTAR AUTO A-FLEX, SYS ONE, 60 SRS,GER
FDA Adverse Event
Malfunction
·PHILIPS RESPIRONICS, INC.·Product code BZD·July 21, 2021
REMSTAR PRO C-FLEX+, SYS ONE, 60 SRS,GER
FDA Adverse Event
Death
·RESPIRONICS INC·Product code BZD·August 26, 2021
REMSTAR PRO C-FLEX+, SYS ONE, 60 SRS,GER
FDA Adverse Event
Malfunction
·RESPIRONICS, INC.·Product code BZD·September 23, 2021
REMSTAR AUTO A-FLEX, SYS ONE, 60 SRS,GER
FDA Adverse Event
Malfunction
·RESPIRONICS INC·Product code BZD·August 18, 2021
PUMP MMT-1741KX 670G V6.3 SF MG CLIN GER
FDA Adverse Event
Malfunction
·MEDTRONIC PUERTO RICO OPERATIONS CO.·Product code OZP·September 8, 2021
REMSTAR AUTO A-FLEX, SYS ONE, 60 SRS,GER
FDA Adverse Event
Injury
·RESPIRONICS, INC·Product code BZD·August 3, 2021
REMSTAR AUTO A-FLEX, SYS ONE, 60 SRS, GER
FDA Adverse Event
Malfunction
·RESPORINOC INC·Product code BZD·August 5, 2021
REMSTAR PRO C-FLEX+, SYS ONE, 60 SRS,GER
FDA Adverse Event
Injury
·RESPIRONICS INC·Product code BZD·September 2, 2021
REMSTAR AUTO A-FLEX, SYS ONE, 60 SRS,GER
FDA Adverse Event
Malfunction
·RESPIRONICS, INC.·Product code BZD·September 27, 2021
REMSTAR PRO C-FLEX+, SYS ONE, 60 SRS,GER
FDA Adverse Event
Malfunction
·RESPIRONICS, INC.·Product code BZD·January 3, 2025
Medtronic O-arm Imaging System Product Usage: image-intensified fluoroscopic x-ray system, mobile
FDA Enforcement
Class II
·Terminated·Medtronic Navigation, Inc.·March 20, 2013
OMNIPOD INSULIN PUMP
FDA Adverse Event
Malfunction
·INSULET CORPORATION·Product code LZG·January 23, 2013
INTELLIS
FDA Adverse Event
Malfunction
·MEDTRONIC PUERTO RICO OPERATIONS CO.·Product code LGW·August 2, 2023
SHAFT COMPL.D:10MM L:370MM
FDA Adverse Event
Malfunction
·AESCULAP AG·Product code OCW·October 19, 2016
Harmony Equipment Management System, Model #603X/80XX, STERIS Corporation, Mentor, OH Harmony Equipment Management Systems (EMS) are used in hospital facilities to provide ready access to medical gasses, electrical power and audio/visual data services, in addition to managing surgical support equipment such as endoscopic equipment, cautery devices and insufflators.
FDA Enforcement
Class II
·Terminated·Steris Corporation·November 13, 2013
O-arm 1000 2nd Edition Imaging System, OARM ASSY Bl70000027GER SYS PRODUCT GER, Model Number Bl70000027GER Product Usage: The O-arm Imaging System is a mobile x-ray system designed for 2D fluoroscopic and 3D imaging and is intended to be used where a physician benefits from 2D and 3D information of anatomic structures and objects with high x-ray attenuation such as bony anatomy and metallic objects. The 0-arm Imaging System is compatible with certain Image Guided Surgery Systems.
FDA Enforcement
Class II
·Terminated·Medtronic Navigation, Inc.-Littleton·October 31, 2018
AMPLIFON
FDA UDI
Starkey Laboratories, Inc.·00842318198174·
AMPLIFON
FDA UDI
Starkey Laboratories, Inc.·00840388201879·