43 results
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69ms
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Sources: EU EUDAMED, US FDA
RetCam Portable
FDA UDI
CLARITY MEDICAL SYSTEMS, INC.·00899281002137·The RetCam Portable Ophthalmic Imaging System i...
RetCam Shuttle
FDA UDI
CLARITY MEDICAL SYSTEMS, INC.·00899281002120·The RetCam Shuttle Ophthalmic Imaging System is...
RetCam 3
FDA UDI
CLARITY MEDICAL SYSTEMS, INC.·00899281002113·RetCam 3 Ophthalmic Imaging System is designed ...
RETCAM II
FDA Adverse Event
Injury
·CLARITY MEDICAL SYSTEMS, INC.·Product code HKI·March 13, 2009
RetCam 3, RetCam Portable and RetCam Shuttle; manufactured by Clarity Medical Systems, Inc.; Pleasanton, CA 94588. General ophthalmic imaging including retinal, corneal and external imaging.
FDA Enforcement
Class II
·Terminated·Clarity Medical Systems Inc·March 19, 2014
Retcam3 & Retcam Shuttle with version 6.0 software. Clarity Medical Systems, Inc. 5775 W. Las Positas Blvd, Suite 200 Pleasanton, CA 94588 General ophthalmic imaging including retinal, corneal and external imaging. Photodocumentation of pediatric ocular diseases including retinopathy or prematurity (ROP). Screening of Type-2 re-threshold retinopathy of prematurity or treatment requiring ROP.
FDA Recall
Terminated
·Clarity Medical Systems Inc·Product code HKI·February 2, 2012
Halogen Lamp component in RetCam 3 System - Clarity Medical Systems, Inc; Pleasanton, CA. General ophthalmic imaging including retinal, corneal and external imaging. Photo-documentation of pediatric ocular diseases including retinopathy of prematurity. Screening for Type-2 re-threshold retinopathy of prematurity or treatment requiring ROP.
FDA Enforcement
Class II
·Terminated·Clarity Medical Systems Inc·March 26, 2014
RetCam 3, RetCam Portable and RetCam Shuttle; manufactured by Clarity Medical Systems, Inc.; Pleasanton, CA 94588. General ophthalmic imaging including retinal, corneal and external imaging.
FDA Recall
Terminated
·Clarity Medical Systems Inc·Product code HKI·January 24, 2014
RETCAM 3
FDA Adverse Event
Malfunction
·CLARITY MEDICAL SYSTEMS, INC.·Product code HKI·January 22, 2014
RETCAM II
FDA Adverse Event
Injury
·CLARITY MEDICAL SYSTEMS, INC·Product code HKI·November 24, 2008
RETCAM 3
FDA Adverse Event
Malfunction
·CLARITY MEDICAL SYSTEMS, INC.·Product code HKI·August 13, 2014
RETCAM 3
FDA Adverse Event
Malfunction
·CLARITY MEDICAL SYSTEMS INC.·Product code HKI·August 13, 2014
RETCAM 120
FDA Adverse Event
Malfunction
·CLARITY MEDICAL SYSTEMS, INC.·Product code HKI·April 13, 2006
RETCAM SHUTTLE
FDA Adverse Event
Malfunction
·CLARITY MEDICAL SYSTEMS, INC.·Product code HKI·January 27, 2016
RETCAM SHUTTLE
FDA Adverse Event
Malfunction
·CLARITY MEDICAL SYSTEMS, INC.·Product code HKI·January 28, 2016
RETCAM SHUTTLE
FDA Adverse Event
Malfunction
·CLARITY MEDICAL SYSTEMS INC·Product code HKI·February 12, 2012
RETCAM SHUTTLE
FDA Adverse Event
Malfunction
·CLARITY MEDICAL SYSTEMS INC·Product code HKI·February 12, 2012
RETCAM 3
FDA Adverse Event
CLARITY MEDICAL SYSTEMS, INC.·Product code HKI·June 16, 2016
RETCAM SHUTTLE PEDIATRIC IMAGING SYSTEM
FDA Adverse Event
Malfunction
·CLARITY MEDICAL SYSTEMS, INC.·Product code HKI·October 16, 2015
Halogen Lamp component in RetCam 3 System - Clarity Medical Systems, Inc; Pleasanton, CA. General ophthalmic imaging including retinal, corneal and external imaging. Photo-documentation of pediatric ocular diseases including retinopathy of prematurity. Screening for Type-2 re-threshold retinopathy of prematurity or treatment requiring ROP.
FDA Recall
Terminated
·Clarity Medical Systems Inc·Product code HKI·March 7, 2014