6 results
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12ms
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Sources: EU EUDAMED, US FDA
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Status: Terminated
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iQ200 Series Urine Microscopy Analyzer- All part numbers
FDA Enforcement
Class II
·Terminated·Beckman Coulter Inc.·May 20, 2020
iQ200 Series Urine Microscopy Analyzer, Catalog numbers: 700-3345, 700-3375, 700-3325, 700-3347, 700-3300RFB, 700- 3320, 700-3320RFB, 700-3322, 700-3322RFB, 700-3326, 700- 3340, 700-3370, B48999, C10683, C10684 - Product Usage: device used to automate the complete urinalysis profile, including urine test strip chemistry panel and microscopic sediment analysis.
FDA Enforcement
Class II
·Terminated·Beckman Coulter Inc.·February 5, 2020
BECKMAN COULTER iQ200 Series Urine Microscopy Analyzer, Catalog Numbers: 700-3345, C10684, 700-3375, C10683, 700-3325, 700-3347, 700-3320, 700-3322, 700-3370
FDA Recall
Terminated
·Beckman Coulter Inc.·Product code KQO·March 2, 2018
BECKMAN COULTER iQ200 Series Urine Microscopy Analyzer, Catalog Numbers: 700-3345, C10684, 700-3375, C10683, 700-3325, 700-3347, 700-3320, 700-3322, 700-3370
FDA Enforcement
Class II
·Terminated·Beckman Coulter Inc.·April 18, 2018
iQ200 Series Urine Microscopy Analyzer, Catalog numbers: 700-3345, 700-3375, 700-3325, 700-3347, 700-3300RFB, 700- 3320, 700-3320RFB, 700-3322, 700-3322RFB, 700-3326, 700- 3340, 700-3370, B48999, C10683, C10684 - Product Usage: device used to automate the complete urinalysis profile, including urine test strip chemistry panel and microscopic sediment analysis.
FDA Recall
Terminated
·Beckman Coulter Inc.·Product code LKM·October 28, 2019
Boston Scientific/Cameron Health SQ-RX Model 1010 subcutaneous pulse generators. The S-ICD System is intended to provide therapy for the treatment of life-threatening ventricular tachyarrhythmias.
FDA Enforcement
Class II
·Terminated·Boston Scientific CRM Corp·March 27, 2013