8 results
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28ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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PROTECTIVE RESTRAINT - BELTS
FDA 510(k)
FDA Class 1
·General Hospital
SPACELABS MEDICAL FULL DISCLOSURE SYSTEM, MODEL 91810
FDA 510(k)
FDA Class 2
·Cardiovascular
StatStrip Xpress 2 Glucose Hospital Meter System
FDA 510(k)
FDA Class 2
·Clinical Chemistry
INRATIO PT/INR TEST STRIPS
FDA Adverse Event
Malfunction
·ALERE SAN DIEGO, INC.·Product code GJS·May 30, 2014
APEX KNEE SYSTEM
FDA Adverse Event
Injury
·OMNLIFE SCIENCE, INC.·Product code JWH·February 13, 2013
SYNCHROMED EL
FDA Adverse Event
Malfunction
·RICE CREEK MFG·Product code LKK·December 20, 2010
ELECSYS TSH ASSAY
FDA Adverse Event
Malfunction
·ROCHE DIAGNOSTICS·Product code JLW·November 9, 2020
FT4, FREE THYROXINE
FDA Adverse Event
Malfunction
·ROCHE DIAGNOSTICS·Product code CEC·September 30, 2016