7 results
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23ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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HOWMEDICA KINEMATIC II MODULAR TIBIAL COMPONENT
FDA 510(k)
FDA Class 2
·Orthopedic
NEUROSIGN LARYNGEAL ELECTRODES
FDA 510(k)
FDA Class 2
·Ear, Nose, Throat
MODIFICATION TO KIDNEY DIALYZER
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
SOFTHEAT
FDA Adverse Event
Other
·KAZ, INC.·Product code IRT·December 6, 2012
SMALL BATTERY DRIVE II
FDA Adverse Event
Malfunction
·DEPUY SYNTHES POWER TOOLS·Product code HWE·June 13, 2014
INTERSTIM II
FDA Adverse Event
Injury
·MEDTRONIC MED REL MEDTRONIC PUERTO RICO·Product code EZW·June 26, 2015
Azurion 7 M20 FlexArm system (Software version R2.x) with Maquet Magnus Table (Software version 05.02.12)
FDA Enforcement
Class II
·Ongoing·PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.·February 7, 2024