8 results
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19ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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Colibrí
FDA 510(k)
FDA Class 2
·Microbiology
HQ-Chex
FDA UDI
STRECK, INC.·00844509001713·A whole blood glucose and hemoglobin control de...
A-DEC 532/533 DELIVERY SYSTEM MODEL, 532/533
FDA 510(k)
FDA Class 1
·Dental
Clariti 1 Day (somofilcon A), Clariti 1 Day Toric (somofilcon A), Clariti 1 Day Multifocal (somofilcon A), Clariti 1 Day Multifocal Toric (somofilcon A)
FDA 510(k)
FDA Class 2
·Ophthalmic
UNKNOWN DEPUY LRG CLASSIC TRAY
FDA Adverse Event
Injury
·DEPUY ORTHOPAEDICS, INC.·Product code JWH·August 18, 2011
ACCU-CHEK COMFORT CURVE TEST STRIPS
FDA Adverse Event
Malfunction
·ROCHE DIAGNOSTICS·Product code LFR·November 14, 2008
ARTICULEZE M HEAD 36MM +12
FDA Adverse Event
Injury
·DEPUY ORTHOPAEDICS INC US·Product code JDI·July 18, 2013
Allura Xper FD20; Model Numbers: (1) 722006, (2) 722012, (3) 722028; Associated 510(k)s: K102005, K130638, K130842, K133292, K141979, K162859, K161563;
FDA Enforcement
Class II
·Ongoing·PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.·October 8, 2025