7 results
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19ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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SUNGLASSES
FDA 510(k)
FDA Class 1
·Ophthalmic
STERRAD® NX Sterilizer with ALLClear Technology
FDA 510(k)
FDA Class 2
·General Hospital
ARCHITECT SHBG REAGENT KIT, ARCHITECT SHBG CALIBRATOR KIT, AND ARCHITECT SHBG CONTROL KIT WITH MODELS, 8K26-25, 8K26-01
FDA 510(k)
FDA Class 1
·Clinical Chemistry
AZO
FDA Adverse Event
Other
·SIEMENS DIAGNOSTICS, INC.·Product code CEN·July 12, 2012
8800
FDA Adverse Event
Malfunction
·GE OEC MEDICAL SYSTEMS·Product code JAA·June 27, 2014
THERAKOS CELLEX PHOTOPHERESIS SYSTEM
FDA Adverse Event
Injury
·THERAKOS·Product code LNR·February 11, 2013
HEART START XL
FDA Adverse Event
Malfunction
·PHILIPS HEALTHCARE·Product code MKJ·December 17, 2010