9 results
·
28ms
·
Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
×
CardIQ Suite
FDA 510(k)
FDA Class 2
·Radiology
Washing Solution Additive
FDA UDI
Phadia AB·07333066019932·Washing Solution Additive
NOBELACTIVE WIDE PLATFORM (WP)
FDA 510(k)
FDA Class 2
·Dental
AXSYM CORTISOL ASSAY
FDA 510(k)
FDA Class 2
·Clinical Chemistry
IMP,TSV,MCOL MG,4.1MM,11.5MML
FDA Adverse Event
Injury
·ZIMMER DENTAL·Product code DZE·May 27, 2022
DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM
FDA Adverse Event
Malfunction
·DEXCOM, INC.·Product code QBJ·August 22, 2025
PARADIGM REAL-TIME INSULIN INFUSION PUMP
FDA Adverse Event
Malfunction
·MEDTRONIC PUERTO RICO OPERATIONS CO.·Product code OYC·November 6, 2014
ACCESS® 2 IMMUNOASSAY SYSTEM
FDA Adverse Event
Malfunction
·BECKMAN COULTER INC.·Product code JJE·September 3, 2011
COAGUCHEK ® XS SYSTEM
FDA Adverse Event
Malfunction
·ROCHE DIAGNOSTICS·Product code GJS·July 18, 2013