9 results
·
22ms
·
Sources: EU EUDAMED, US FDA
ISOSTATION SHOULDER MACHINE
FDA 510(k)
FDA Class 2
·Physical Medicine
MEDRAD Centargo CT Injection System; MEDRAD Centargo Day Set; MEDRAD Centargo Patient Line; MEDRAD Centargo Replacement Spike; MEDRAD ISI2 Module (ISI2)
FDA 510(k)
FDA Class 2
·Cardiovascular
TURBO-FLO PICC
FDA 510(k)
FDA Class 2
·General Hospital
SENSOR
FDA Adverse Event
Malfunction
·MEDTRONIC MINIMED·Product code OZO·May 30, 2014
SYNCHROMED II
FDA Adverse Event
Injury
·MDT PUERTO RICO OPERATIONS CO·Product code LKK·November 21, 2012
TERUMO PERFUSION SYSTEM 8000
FDA Adverse Event
Malfunction
·TERUMO CARDIOVASCULAR SYSTEMS CORP.·Product code JOR·September 21, 2010
PLATE, FIXATION, BONE
FDA Adverse Event
Injury
·ACUMED, LLC·Product code HRS·August 19, 2025
PLATE, FIXATION, BONE
FDA Adverse Event
Injury
·ACUMED, LLC·Product code HRS·August 19, 2025
TFN-ADVANCED Proximal Femoral Nailing System (TFNA); for treatment of fractures in orthopedics and trauma.
FDA Enforcement
Class II
·Terminated·Synthes, Inc.·May 20, 2015