10 results
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21ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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UA PERFECT AUTOMATED ANALYSIS ASSAY FOR UROBILLINOGEN IN URINE
FDA 510(k)
FDA Class 1
·Clinical Chemistry
Zavation
FDA UDI
Zavation LLC·00842166171626·Self Tapping Variable Screw, 4.5mmx14
ZAVATION
FDA UDI
Zavation LLC·00842166117518·Polyaxial Screw 4.5mm x 14mm
Duo Ti Expandable Interbody Fusion System
FDA UDI
SPINEOLOGY INC.·M7402954514·Duo Ti, 45 x 14mm, 0°
STRUNG TELFA NON-ADHERENT SPONGE
FDA 510(k)
FDA Class 2
·Neurology
AMBI-24 PH/PRESSURE MONITOR
FDA 510(k)
FDA Class 1
·Gastroenterology, Urology
DRUG ELUTING PERMANENT LEFT VENTRICULAR (LV) PACEMAKER ELECTRODE
FDA Adverse Event
Injury
·MPRI·Product code OJX·February 11, 2013
PRECISION XTRA
FDA Adverse Event
Malfunction
·Product code NBW·January 10, 2011
FRESENIUS 2008K
FDA Adverse Event
Death
·FRESENIUS MEDICAL CARE NORTH AMERICA·Product code KDI·July 17, 2014
ev3 Pipeline Flex Embolization Device with Shield Technology. Sold OUS. For neurological endovascular use.
FDA Enforcement
Class I
·Terminated·Micro Therapeutics Inc, Dba Ev3 Neurovascular·April 1, 2020