7 results
·
34ms
·
Sources: EU EUDAMED, US FDA
VARIAN C-SERIES CLINACS CLINAC 600C,2100C,2500C
FDA 510(k)
FDA Class 2
·Radiology
GERARD MEDICAL, INC. TRIM-PORT
FDA 510(k)
FDA Class 2
·General Hospital
HGP II TOTAL HIP FEMERAL STEM
FDA 510(k)
FDA Class 2
·Orthopedic
EON IMPLANTABLE PULSE GENERATOR
FDA Adverse Event
Malfunction
·ADVANCED NEUROMODULATION SYSTEMS·Product code LGW·October 28, 2010
LOCKING SCREW
FDA Adverse Event
Injury
·SYNTHES (USA)·Product code HWC·January 9, 2013
INGENIO
FDA Adverse Event
Malfunction
·GUIDANT CRM CLONMEL IRELAND·Product code LWP·July 1, 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