9 results
·
23ms
·
Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
×
QIAstat-Dx Respiratory Panel
FDA 510(k)
FDA Class 2
·Microbiology
SONOWAND INVITE
FDA 510(k)
FDA Class 2
·Neurology
DX-D 100
FDA 510(k)
FDA Class 2
·Radiology
TOTAL KNEE REPLACEMENT CEMENT KLASSIC TOTAL KNEE SYSTEM
FDA Adverse Event
Injury
·TOTAL JOINT ORTHOPEDICS, INC.·Product code JWH·August 18, 2020
DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM
FDA Adverse Event
Malfunction
·DEXCOM, INC.·Product code QBJ·July 14, 2025
BINAXNOW COVID-19 ANTIGEN SELF-TEST
FDA Adverse Event
Malfunction
·ABBOTT DIAGNOSTICS SCARBOROUGH, INC.·Product code QKP·September 13, 2022
COLLEAGUE 3 VOLUMETRIC INFUSION PUMP
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE PTE. LTD.·Product code FRN·October 4, 2008
UNICEL DXC 800 SYNCHRON SYSTEM
FDA Adverse Event
Malfunction
·BECKMAN COULTER, INC.·Product code JJE·July 8, 2011
DRILL BIT Ø2/1.15 CANN L150/48 3FLUTE
FDA Adverse Event
Malfunction
·SYNTHES GMBH·Product code HWE·June 22, 2013