7 results
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19ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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Video Colposcope
FDA 510(k)
FDA Class 2
·Obstetrics/Gynecology
GE LOGIQ P5 MODEL H44662LD
FDA 510(k)
FDA Class 2
·Radiology
PROTEXIS LATEX BLUE WITH NEU-THERA POWDER-FREE SURGICAL GLOVES
FDA 510(k)
FDA Class 1
·General, Plastic Surgery
TRANSPAC IV MONITORING KIT
FDA Adverse Event
Other
·ICU MEDICAL, INC.·Product code DRS·May 20, 2013
SYNCHRON ® CX DELTA CLINICAL SYSTEMS
FDA Adverse Event
Malfunction
·BECKMAN COULTER INC.·Product code CGX·July 6, 2011
PORTABLE OXYGEN GENERATOR (CONCENTRATOR, HOMEFILL)
FDA Adverse Event
Malfunction
·INVACARE FLORIDA OPERATIONS·Product code CAW·October 8, 2014
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