94 results
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11ms
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Sources: EU EUDAMED, US FDA
Filters
Status: Completed
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microStar Reader, Model Numbers: 10015-000 (marketed in EMEA as 100, 102, 110, and 201), 10016-000 (marketed in EMEA as 101), 10036-000, 10044-000, 10055-000, BC30058, and BC30059
FDA Enforcement
Class II
·Completed·Landauer·March 27, 2024
Landauer microSTARii reader, Medical Dosimetry System, Model Numbers: 18000-000/18001-000/18007-000
FDA Enforcement
Class II
·Completed·Landauer·January 3, 2024
microStar Reader, Model Numbers: 10015-000 (marketed in EMEA as 100, 102, 110, and 201), 10016-000 (marketed in EMEA as 101), 10036-000, 10044-000, 10055-000, BC30058, and BC30059
FDA Recall
Completed
·Product code LHO·February 8, 2024
Landauer microSTARii reader, Medical Dosimetry System, Model Numbers: 18000-000/18001-000/18007-000
FDA Recall
Completed
·Product code IYE·November 15, 2023
nanoDot B - item 2 of 3 for 03500-000, Model Number 03502-000; radiation monitoring dosimeter used with the microSTAR readers
FDA Enforcement
Class II
·Completed·Landauer·September 20, 2023
nanoDot A - item 1 of 3 for 03500-000, Model Number 03501-000; radiation monitoring dosimeter used with the microSTAR readers
FDA Enforcement
Class II
·Completed·Landauer·September 20, 2023
nanoDot C - item 3 of 3 for 03500-000, Model Number 03503-000; radiation monitoring dosimeter used with the microSTAR readers
FDA Enforcement
Class II
·Completed·Landauer·September 20, 2023
nanoDot A - item 1 of 3 for 03500-000, Model Number 03501-000; radiation monitoring dosimeter used with the microSTAR readers
FDA Recall
Completed
·Product code IYE·July 12, 2023
nanoDot C - item 3 of 3 for 03500-000, Model Number 03503-000; radiation monitoring dosimeter used with the microSTAR readers
FDA Recall
Completed
·Product code IYE·July 12, 2023
nanoDot B - item 2 of 3 for 03500-000, Model Number 03502-000; radiation monitoring dosimeter used with the microSTAR readers
FDA Recall
Completed
·Product code IYE·July 12, 2023
NanoDots, Model Number 04297-000; radiation monitoring dosimeter used with the microSTAR readers
FDA Enforcement
Class II
·Completed·Landauer·September 20, 2023
NanoDots, Model Number 04297-000; radiation monitoring dosimeter used with the microSTAR readers
FDA Recall
Completed
·Product code IYE·July 12, 2023
AD-TECH Spencer Probe Depth Electrode, REF SD04R-AP58X-000 4-Contact 1.12mm (A style) Depth Electrode
FDA Enforcement
Class II
·Completed·Ad-Tech Medical Instrument Corporation·October 30, 2024
AD-TECH Spencer Probe Depth Electrode, REF SD06R-AP58X-000 6-Contact 1.12mm (A style) Depth Electrode
FDA Enforcement
Class II
·Completed·Ad-Tech Medical Instrument Corporation·October 30, 2024
AD-TECH Spencer Probe Depth Electrode, REF SD08R-AP58X-000 8-Contact 1.12mm (A style) Depth Electrode
FDA Enforcement
Class II
·Completed·Ad-Tech Medical Instrument Corporation·October 30, 2024
nanoDot D2DNN , Model Numbers: a) 04293-000; b) 04293-KIT; radiation monitoring dosimeter used with the microSTAR readers
FDA Enforcement
Class II
·Completed·Landauer·September 20, 2023
nanoDot D2DNN, Model Numbers: a) 18105-000; b) 18105-KIT; radiation monitoring dosimeter used with the microSTAR readers
FDA Enforcement
Class II
·Completed·Landauer·September 20, 2023
nanoDot kit (contains nanoDot A, B, C), Model Number 03500-000; radiation monitoring dosimeter used with the microSTAR readers
FDA Enforcement
Class II
·Completed·Landauer·September 20, 2023
nanoDot D2DNN, Model Numbers: a) 18105-000; b) 18105-KIT; radiation monitoring dosimeter used with the microSTAR readers
FDA Recall
Completed
·Product code IYE·July 12, 2023
nanoDot D2DNN , Model Numbers: a) 04293-000; b) 04293-KIT; radiation monitoring dosimeter used with the microSTAR readers
FDA Recall
Completed
·Product code IYE·July 12, 2023