34 results
·
29ms
·
Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
×
SALTER LABS ORAL/NASAL THERMAL AIRFLOW SENSOR
FDA 510(k)
FDA Class 2
·Anesthesiology
DEXCOM G6 CONTINUOUS GLUCOSE MONITORING SYSTEM
FDA Adverse Event
Malfunction
·DEXCOM, INC.·Product code QBJ·June 23, 2025
EVOLUT FX PLUS VALVE
FDA Adverse Event
Malfunction
·MEDTRONIC HEART VALVES DIVISION·Product code NPT·June 23, 2025
TALOS® IBF
FDA UDI
MEDITECH SPINE, LLC·B16710809220·
Yellowstone
FDA UDI
SUMMIT SPINE LLC·B587P0809220·8mm PLIF Implant 9mm Wide 22mm Length
Yellowstone
FDA UDI
SUMMIT SPINE LLC·B587P08092270·8mm PLIF Implant 9mm Wide 20mm Length 7 Degrees
Ardis®
FDA UDI
ZIMMER SPINE, INC.·00889024334274·
ZEUS-P
FDA UDI
SPINAL ELEMENTS·00840916153212·Zeus-P Trial, 8 x 9 x 22mm
Ardis®
FDA UDI
ZIMMER SPINE, INC.·00889024333543·
OLYMPUS EMPOWER H65
FDA Adverse Event
Malfunction
·QUANTA SYSTEM S.P.A.·Product code GEX·May 19, 2022
PROTON VISION
FDA 510(k)
FDA Class 2
·Radiology
TRI-FIX SPINAL FIXATION SYSTEM
FDA 510(k)
FDA Class 2
·Orthopedic
FIX-L PEEK PLIF and T-PLIF System
FDA UDI
Jeil Medical Corporation·08800089471782·
FIX-L PEEK PLIF and T-PLIF System
FDA UDI
Jeil Medical Corporation·08800089471775·
FIX-L PEEK PLIF and T-PLIF System
FDA UDI
Jeil Medical Corporation·08800089471737·
FIX-L PEEK PLIF and T-PLIF System
FDA UDI
Jeil Medical Corporation·08800089471713·
FIX-L PEEK PLIF and T-PLIF System
FDA UDI
Jeil Medical Corporation·08800089471744·
FIX-L PEEK PLIF and T-PLIF System
FDA UDI
Jeil Medical Corporation·08800089471751·
FIX-L PEEK PLIF and T-PLIF System
FDA UDI
Jeil Medical Corporation·08800089471706·
FIX-L PEEK PLIF and T-PLIF System
FDA UDI
Jeil Medical Corporation·08800089471768·