7 results
·
27ms
·
Sources: EU EUDAMED, US FDA
COLLIMASTER-90
FDA 510(k)
FDA Class 2
·Radiology
Advanced Intermezzo Implant System
FDA 510(k)
FDA Class 2
·Dental
ROMEO POSTERIOR OSTEOSYNTHESIS SYSTEM
FDA 510(k)
FDA Class 2
·Orthopedic
FREESTYLE LITE
FDA Adverse Event
Injury
·Product code NBW·January 11, 2013
ETHICON HARMONIC FOCUS
FDA Adverse Event
Malfunction
·ASCENT HEALTHCARE SOLUTIONS·Product code LFL·November 29, 2010
DURATA STS OPTIM ACTIVE FIXATION
FDA Adverse Event
Injury
·ST. JUDE MEDICAL, INC., CRMD·Product code NVY·July 2, 2014
1202 Flex Focus Ultrasound System, cart models UA1214 and UA1814, used with: Flex Focus 200, Flex Focus 300, Flex Focus 400, Flex Focus 500, Flex Focus 700, Flex Focus 800; System, Imaging, Pulsed Doppler, Ultrasonic
FDA Enforcement
Class II
·Ongoing·B-K Medical A/S·November 12, 2025