7 results
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14ms
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Sources: EU EUDAMED, US FDA
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Status: Completed
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Brand Name: UNclog Eye Mask Product Name: UNclog Eye Mask Model/Catalog Number: AG23JW24 Serial # ag22 Product Description: Heated eye mask Component: Heating unit, wire
FDA Recall
Completed
·EYE COMFORT CARE LLC·Product code IRT·February 8, 2024
Brand Name: UNclog Eye Mask Product Name: UNclog Eye Mask Model/Catalog Number: AG23JW24 Serial # ag22 Product Description: Heated eye mask Component: Heating unit, wire
FDA Enforcement
Class II
·Completed·EYE COMFORT CARE LLC·August 21, 2024
TrueDent Cyan, TDM 120, Model No. OBJ-09165 Light-curable methacrylate-based resin that enables fabrication of dental appliances
FDA Recall
Completed
·STRATASYS LTD·Product code EBI·January 19, 2024
TrueDent Magenta, TDM130, Model No. OBJ-09166 Light-curable methacrylate-based resin that enables fabrication of dental appliances
FDA Recall
Completed
·STRATASYS LTD·Product code EBI·January 19, 2024
TrueDent White, TDM110, Model No. OBJ-09168 Light-curable methacrylate-based resin that enables fabrication of dental appliances
FDA Recall
Completed
·STRATASYS LTD·Product code EBI·January 19, 2024
TrueDent Clear, TDM 100, Model No. OBJ-09164 Light-curable methacrylate-based resin that enables fabrication of dental appliances
FDA Recall
Completed
·STRATASYS LTD·Product code EBI·January 19, 2024
TrueDent Yellow, TDM140, Model No. OBJ-09169 Light-curable methacrylate-based resin that enables fabrication of dental appliances
FDA Recall
Completed
·STRATASYS LTD·Product code EBI·January 19, 2024