8 results
·
26ms
·
Sources: EU EUDAMED, US FDA
SLS 3500 LED VISUAL STIMULATOR
FDA 510(k)
FDA Class 2
·Neurology
Xia 3 Spinal System
FDA 510(k)
FDA Class 2
·Orthopedic
CORONARY SINUS VISUALIZATION SYSTEM, MODEL CSVS5508
FDA 510(k)
FDA Class 2
·Cardiovascular
PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP
FDA Adverse Event
Injury
·MEDTRONIC MINIMED·Product code OYC·June 1, 2014
GPS STRETCHER
FDA Adverse Event
Malfunction
·HILL-ROM INC·Product code FPO·November 9, 2012
HUMAPEN MEMOIR
FDA Adverse Event
Malfunction
·ELI LILLY AND COMPANY·Product code NSC·September 23, 2010
XIA TITANIUM 4.5 BLOCKER
FDA Adverse Event
Malfunction
·STRYKER SPINE-US·Product code NKB·September 3, 2020
PM3544 QUADRA RELIEVE and PM3562 QUADRA ALLURE MP These low voltage (LV) devices are implantable pacemaker pulse generators, intended to be permanently implanted in the body, that have a power supply and electronic circuits that produce a periodic electrical pulse to stimulate the heart. These devices are used as a substitute for the heart's intrinsic pacing system to correct both intermittent and continuous cardiac rhythm disorders
FDA Enforcement
Class II
·Terminated·St Jude Medical Inc.·October 25, 2017