10 results
·
27ms
·
Sources: EU EUDAMED, US FDA
BI-LEVEL ASSAYED URINE METAL CONTROL
FDA 510(k)
FDA Class 1
·Clinical Chemistry
OVATION®
FDA UDI
DENTSPLY SIRONA ORTHODONTICS INC.·D807K82055261·OVATION® Base Rx SP 022 UL/5-5 CS-BC DHK
OVATION®
FDA UDI
DENTSPLY SIRONA ORTHODONTICS INC.·D807K82055241·OVATION® Base Rx 022 UL/5-5 CS-BC MHK
OVATION®
FDA UDI
DENTSPLY SIRONA ORTHODONTICS INC.·D807K82055221·OVATION® Base Rx 022 UL/5-5 CS-BC DHK
RIWO NET OPERATING OPERATING CONTROL SYSTEM, MODEL #5590
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
PHILIPS MICRODOSE
FDA 510(k)
FDA Class 2
·Radiology
DEXCOM G6 CONTINUOUS GLUCOSE MONITORING SYSTEM
FDA Adverse Event
Injury
·DEXCOM, INC.·Product code QBJ·June 27, 2025
GRANUFLO
FDA Adverse Event
Death
·FRESENIUS MEDICAL CARE NORTH AMERICA·Product code KPO·May 9, 2014
CVC SET: 3-LUMEN 8.5FR X 16CM
FDA Adverse Event
Malfunction
·ARROW INTERNATIONAL INC·Product code DQY·October 31, 2012
ONETOUCHPING GLUCOSEMGMTSYSTEM
FDA Adverse Event
Malfunction
·ANIMAS CORPORATION·Product code LZG·June 4, 2015