8 results
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20ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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MAJOLI UTERINE MANIPULATOR/INJECTOR
FDA 510(k)
FDA Class 2
·Obstetrics/Gynecology
CLOSUREFAST RADIOFREQUENCY CATHETER
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
AVALON CUP SYSTEM
FDA 510(k)
FDA Class 2
·Orthopedic
9800
FDA Adverse Event
Malfunction
·GE OEC MEDICAL SYSTEMS (SLC)·Product code JAA·May 13, 2014
STEALTHSTATION S7 SYSTEM
FDA Adverse Event
Malfunction
·MEDTRONIC NAVIGATION, INC.·Product code HAW·January 11, 2013
ONE TOUCH PING GLUCOSE MANAGEMENT SYSTEM
FDA Adverse Event
Malfunction
·ANIMAS CORP.·Product code LZG·November 24, 2010
Synthes Screw Inserter; for use with Intramedullary Rod, orthopedic device. Used to secure the head element to the head element inserter to prevent disengagement during head element insertion.
FDA Enforcement
Class II
·Terminated·Synthes (USA) Products LLC·October 21, 2015
STERRAD 100NX Sterilization System, P/N 10104 Product Usage: The STERRAD 100NX Sterilization System is a general purpose, low temperature sterilizer which uses the STERRAD 100NX process to inactivate microorganisms on a board range of medical devices and surgical instruments.
FDA Enforcement
Class II
·Terminated·Advanced Sterilization Products·April 10, 2013