7 results
·
20ms
·
Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
×
247 BP DEVICE
FDA 510(k)
FDA Class 2
·Cardiovascular
RHIGENE MESACUP2 TEST- SCL-70
FDA 510(k)
FDA Class 2
·Immunology
PACIFIC HEMOSTASIS INR CONTROL PLASMAS, MODEL CATALOG 100560
FDA 510(k)
FDA Class 2
·Hematology
DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM
FDA Adverse Event
Malfunction
·DEXCOM, INC.·Product code QBJ·March 26, 2025
SYSTEM, PERITONEAL, AUTOMATIC DELIVERY
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE·Product code FKX·April 22, 2013
INRATIO
FDA Adverse Event
Malfunction
·ALERE SAN DIEGO, INC.·Product code GJS·April 14, 2011
DIMENSION CLINICAL CHEMISTRY SYSTEM
FDA Adverse Event
Other
·SIEMENS HEALTHCARE DIAGNOSTICS, INC.·Product code MMI·June 27, 2008