8 results
·
26ms
·
Sources: EU EUDAMED, US FDA
MEDTRONIC BIO-MEDICUS BIO-CONSOLE MODEL 550
FDA 510(k)
FDA Class 2
·Cardiovascular
Summit Moldable
FDA UDI
Biogennix, LLC·00812593021955·Summit Moldable 5cc
De Soutter Medical
FDA UDI
DE SOUTTER MEDICAL LIMITED·05051471121935·K-WIRE - DOUBLE TROCAR 2.0mm DIA x 125mm
AUDIOSCREENER OAE+ABR
FDA 510(k)
FDA Class 2
·Ear, Nose, Throat
AMK MODULAR TIBIAL WEDGE SYSTEM
FDA 510(k)
FDA Class 2
·Orthopedic
HOMECHOICE
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE - LARGO·Product code FKX·January 22, 2013
ATTAIN OTW
FDA Adverse Event
Injury
·MPRI·Product code LWP·December 14, 2010
G4 PLATINUM PEDIATRIC CONTINUOUS GLUCOSE MONITORING SYSTEM
FDA Adverse Event
Malfunction
·DEXCOM, INC.·Product code MDS·July 9, 2014