10,000 results
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52ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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QIR Suite
FDA 510(k)
FDA Class 2
·Radiology
C-QIR TACSHIELD
FDA Adverse Event
Injury
·ATRIUM MEDICAL CORPORATION·Product code FTL·May 3, 2021
C-QIR V-PATCH
FDA Adverse Event
Injury
·ATRIUM MEDICAL CORPORATION·Product code FTL·January 26, 2021
STRAIGHT SHELL INSERTER
FDA Adverse Event
Malfunction
·ZIMMER BIOMET, INC.·Product code LXH·June 28, 2019
VIDEO TELESCOPE "ENDOEYE HD II", 5.4 MM, 30°, AUTOCLAVABLE
FDA Adverse Event
Malfunction
·OLYMPUS WINTER & IBE GMBH·Product code HET·July 25, 2024
DARBY PLASTIC HUB NEEDLE 30GA SHORT
FDA Adverse Event
Injury
·SOFIC·Product code DZM·September 13, 2024
JADA SYSTEM
FDA Adverse Event
Injury
·ORGANON LLC·Product code OQY·August 20, 2025
ULTRA SAFETY PLUS TWIST PART A (INJECTION DEVICE)
FDA Adverse Event
Injury
·SEPTODONT S.A.S.·Product code DZM·May 21, 2024
DARBY PLASTIC HUB NEEDLE 30GA SHORT
FDA Adverse Event
Injury
·SOFIC·Product code DZM·September 13, 2024
STRAIGHT SHELL INSERTER
FDA Adverse Event
Malfunction
·ZIMMER BIOMET, INC.·Product code LXH·June 3, 2021
AMP
FDA Adverse Event
Malfunction
·ALPHATEC SPINE, INC.·Product code HTW·May 9, 2022
EVIS EXERA II GASTROINTESTINAL VIDEOSCOPE
FDA Adverse Event
Malfunction
·AIZU OLYMPUS CO., LTD.·Product code FDS·August 14, 2025
CYSTO-NEPHRO VIDEOSCOPE
FDA Adverse Event
Malfunction
·AIZU OLYMPUS CO., LTD.·Product code FAJ·December 20, 2024
VIDEO SYSTEM CENTER
FDA Adverse Event
Malfunction
·OLYMPUS MEDICAL SYSTEMS CORP.·Product code FET·April 14, 2022
EVIS EXERA III VIDEO SYSTEM CENTER
FDA Adverse Event
Malfunction
·SHIRAKAWA OLYMPUS CO., LTD.·Product code FET·August 15, 2024
EVIS EXERA BRONCHOVIDEOSCOPE
FDA Adverse Event
Malfunction
·AIZU OLYMPUS CO., LTD.·Product code EOQ·June 7, 2023
EVIS EXERA III XENON LIGHT SOURCE
FDA Adverse Event
Malfunction
·SHIRAKAWA OLYMPUS CO., LTD.·Product code NWB·October 2, 2024
EVIS EXERA III XENON LIGHT SOURCE
FDA Adverse Event
Malfunction
·SHIRAKAWA OLYMPUS CO., LTD.·Product code NWB·August 26, 2024
VISERA ELITE II VIDEO SYSTEM CENTER
FDA Adverse Event
Malfunction
·SHIRAKAWA OLYMPUS CO., LTD.·Product code FET·September 9, 2024
VISERA 4K UHD CAMERA CONTROL UNIT
FDA Adverse Event
Malfunction
·OLYMPUS MEDICAL SYSTEMS CORP.·Product code FET·June 1, 2022