10,000 results · 52ms · Sources: EU EUDAMED, 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