1,105 results
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100ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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DIGITAL VIDEO RECORDING SYSTEM
FDA 510(k)
FDA Class 2
·Radiology
EVIS X1 VIDEO SYSTEM CENTER
FDA Adverse Event
Malfunction
·SHIRAKAWA OLYMPUS CO., LTD.·Product code FET·December 4, 2025
DA VINCI S SURGICAL SYSTEM
FDA Adverse Event
Malfunction
·INTUITIVE SURGICAL,INC.·Product code NAY·December 4, 2012
DA VINCI S SURGICAL SYSTEM
FDA Adverse Event
Other
·INTUITIVE SURGICAL, INC.·Product code NAY·November 3, 2008
9310HD Digital Video Capture Modules Product Usage: The 9310HD is used to electronically record, display, transfer, and store digital video data of laryngeal or pharyngeal structures, and audio data, for medical and pedagogical applications.
FDA Recall
Terminated
·Pentax of America Inc·Product code GCW·April 13, 2017
9310HD Digital Video Capture Modules Product Usage: The 9310HD is used to electronically record, display, transfer, and store digital video data of laryngeal or pharyngeal structures, and audio data, for medical and pedagogical applications.
FDA Enforcement
Class II
·Terminated·Pentax of America Inc·July 26, 2017
DA VINCI S SURGICAL SYSTEM
FDA Adverse Event
Other
·INTUITIVE SURGICAL, INC.·Product code NAY·March 20, 2009
EVIS EXERA III VIDEO SYSTEM CENTER
FDA Adverse Event
Malfunction
·SHIRAKAWA OLYMPUS CO., LTD.·Product code FET·January 10, 2024
DA VINCI S SURGICAL SYSTEM
FDA Adverse Event
Other
·INTUITIVE SURGICAL,INC.·Product code NAY·December 22, 2011
EVIS EXERA III VIDEO SYSTEM CENTER
FDA Adverse Event
Malfunction
·SHIRAKAWA OLYMPUS CO., LTD.·Product code FET·March 11, 2024
7245C, 7245C/E, 7245D Computer Digital Video System Product Usage: The 7245C, 7245C/E and 7245D are used to electronically record, display, transfer, and store digital video data of behavior related to swallowing in the pharyngeal area for medical and pedagogical applications.
FDA Enforcement
Class II
·Terminated·Pentax of America Inc·July 26, 2017
GlideScope Titanium Single-Use Video Laryngoscope. It is a single-use video laryngoscope system (GlideScope Titanium System) consists of a sterile-packaged, single-use video laryngoscope, multi-use Smart Cable and portable GlideScope video monitor. The system incorporates a high-resolution, full-color digital camera and monitor for real-time viewing and recording. Affected Product Names and Part Numbers: -LoPro S3: 0574-0130 (single blade) or 0270-0769 (box of 10) -LoPro S4: 0574-0131 (single blade) or 0270-0770 (box of 10) -MAC S3: 0574-0132 (single blade) or 0270-0771 (box of 10) -MAC S4: 0574-0133 (single blade) or 0270-0772 (box of 10) The GlideScope Video Laryngoscopes are intended for use by qualified medical professionals to obtain a clear, unobstructed view of the vocal cords for medical procedures.
FDA Enforcement
Class I
·Terminated·Verathon, Inc.·March 16, 2016
7245C, 7245C/E, 7245D Computer Digital Video System Product Usage: The 7245C, 7245C/E and 7245D are used to electronically record, display, transfer, and store digital video data of behavior related to swallowing in the pharyngeal area for medical and pedagogical applications.
FDA Recall
Terminated
·Pentax of America Inc·Product code GCW·April 13, 2017
VISERA VIDEO SYSTEM CENTER
FDA Adverse Event
Malfunction
·SHIRAKAWA OLYMPUS CO., LTD.·Product code FET·May 15, 2024
EVIS EXERA III VIDEO SYSTEM CENTER
FDA Adverse Event
Malfunction
·SHIRAKAWA OLYMPUS CO., LTD.·Product code FET·August 21, 2023
EVIS LUCERA ELITE VIDEO SYSTEM CENTER
FDA Adverse Event
Malfunction
·SHIRAKAWA OLYMPUS CO., LTD.·Product code FET·August 22, 2023
EVIS LUCERA ELITE VIDEO SYSTEM CENTER
FDA Adverse Event
Malfunction
·SHIRAKAWA OLYMPUS CO., LTD.·Product code FET·March 15, 2024
EVIS EXERA III VIDEO SYSTEM CENTER
FDA Adverse Event
Malfunction
·SHIRAKAWA OLYMPUS CO., LTD.·Product code FET·December 21, 2022
EVIS LUCERA ELITE VIDEO SYSTEM CENTER
FDA Adverse Event
Malfunction
·SHIRAKAWA OLYMPUS CO., LTD.·Product code FET·March 28, 2024
EVIS EXERA III VIDEO SYSTEM CENTER
FDA Adverse Event
Malfunction
·SHIRAKAWA OLYMPUS CO., LTD.·Product code FET·November 7, 2024