9 results
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22ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
×
HICAT Air
FDA 510(k)
FDA Class 2
·Radiology
VIZION DR
FDA 510(k)
FDA Class 2
·Radiology
QUIX DIGITAL RADIOGRAPHIC UPGRADE
FDA 510(k)
FDA Class 2
·Radiology
ECOLAB
FDA Adverse Event
ECOLAB·Product code LHC·January 21, 2016
PORTABLE OXYGEN GENERATOR (CONCENTRATOR, HOMEFILL)
FDA Adverse Event
Malfunction
·INVACARE FLORIDA OPERATIONS·Product code CAW·October 8, 2014
TBD
FDA Adverse Event
Malfunction
·MPRI·Product code DTB·June 7, 2013
PLUM A+ DRIVER NEW 8
FDA Adverse Event
Malfunction
·HOSPIRA COSTA RICA, LTD.·Product code FRN·June 24, 2011
WARMER DRAPE
FDA Adverse Event
Malfunction
·MICROTEK DOMINICANA, S.A.·Product code LHC·February 18, 2016
ELEKTA LIMITED Precise Digital Accelerator, REF MRT 6001, MRT 6011; Medical Charged-Particle Radiation Therapy System Accelerator, Linear
FDA Enforcement
Class II
·Ongoing·Elekta, Inc.·December 13, 2023