49 results
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24ms
·
Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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CALIBRATOR FOR AUTOMATED SYSTEMS (C.F.A.S.), MODEL 10759350 360
FDA 510(k)
FDA Class 2
·Clinical Chemistry
Sklar®
FDA UDI
SKLAR CORPORATION·10649111058134·SPRAGUE RAPPAPORT PRPL GLITTER
RANDOX HUMAN ASSSAYED DRUG CONTROL
FDA 510(k)
FDA Class 1
·Clinical Toxicology
PURILENS SALINE SOLUTION
FDA 510(k)
FDA Class 2
·Ophthalmic
AMS GREENLIGHT HPS FIBER
FDA Adverse Event
Malfunction
·AMERICAN MEDICAL SYSTEMS·Product code GEX·December 11, 2012
AMS GREENLIGHT HPS FIBER
FDA Adverse Event
Malfunction
·AMERICAN MEDICAL SYSTEMS·Product code GEX·October 31, 2012
AMS GREENLIGHT HPS FIBER
FDA Adverse Event
Malfunction
·AMS·Product code GEX·October 18, 2012
AMS GREENLIGHT HPS FIBER
FDA Adverse Event
Malfunction
·AMS·Product code GEX·October 18, 2012
DEXCOM G6 CONTINUOUS GLUCOSE MONITORING SYSTEM
FDA Adverse Event
Malfunction
·DEXCOM, INC.·Product code QBJ·March 14, 2025
AMS GREENLIGHT HPS FIBER
FDA Adverse Event
Malfunction
·AMS·Product code GEX·October 22, 2012
AMS GREENLIGHT HPS FIBER
FDA Adverse Event
Malfunction
·AMS·Product code GEX·October 22, 2012
AMS GREENLIGHT HPS FIBER
FDA Adverse Event
Malfunction
·AMERICAN MEDICAL SYSTEMS·Product code GEX·October 22, 2012
AMS GREENLIGHT HPS FIBER
FDA Adverse Event
Malfunction
·AMERICAN MEDICAL SYSTEMS·Product code GEX·October 22, 2012
AMS GREENLIGHT HPS FIBER
FDA Adverse Event
Injury
·AMERICAN MEDICAL SYSTEMS·Product code GEX·October 22, 2012
AMS GREENLIGH HPS FIBER
FDA Adverse Event
Malfunction
·AMERICAN MEDICAL SYSTEMS·Product code GEX·February 12, 2013
AMS GREENLIGHT HPS FIBER
FDA Adverse Event
Malfunction
·AMERICAN MEDICAL SYSTEMS·Product code GEX·October 22, 2012
AMS GREENLIGHT HPS FIBER
FDA Adverse Event
Malfunction
·AMERICAN MEDICAL SYSTEMS·Product code GEX·October 22, 2012
AMS GREENLIGHT HPS FIBER
FDA Adverse Event
Injury
·AMERICAN MED SYSTEMS·Product code GEX·October 22, 2012
AMS GREENLIGHT HPS FIBER
FDA Adverse Event
Malfunction
·AMS·Product code GEX·October 22, 2012
AMS GREENLIGHT HPS FIBER
FDA Adverse Event
Injury
·AMERICAN MEDICAL SYSTEMS, INC.·Product code GEX·October 22, 2012