8 results
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21ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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MONARCH IOL DELIVERY SYSTEM
FDA 510(k)
FDA Class 1
·Ophthalmic
Polystar Selection EDITION
FDA UDI
Merz Dental GmbH·D7091981571·anteriors; shade A3 light; mould CS2
L/U ARM-VASCULAR
FDA 510(k)
FDA Class 1
·Radiology
OASYS Oral/Nasal Airway System and OASYS Herbst with Dentitrac Patient Monitor
FDA 510(k)
FDA Class 2
·Dental
OPTI-FREE PLUS
FDA Adverse Event
Injury
·ALCON LABORATORIES, INC.·Product code LPN·December 12, 2017
ENRHYTHM
FDA Adverse Event
Death
·IPG MFG SWITZERLAND·Product code NVZ·February 27, 2013
7700
FDA Adverse Event
Malfunction
·GE OEC MEDICAL SYSTEMS GMBH·Product code JAA·January 31, 2011
COAGUCHEK ® XS SYSTEM
FDA Adverse Event
Malfunction
·ROCHE DIAGNOSTICS·Product code GJS·August 5, 2014