8 results
·
23ms
·
Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
×
MODIFIED FORMED-EXTENSION MAHURKAR DUAL LUMEN CATH
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
LOGIC 4K CAMERA CONTROLLER, LOGIC 4K CAMERA HEAD
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
MODIFIED HD GUIDE CATHETER
FDA 510(k)
FDA Class 2
·Cardiovascular
ANGIOGUARD RX EMBOLI CAPTURE GUIDEWIRE SYSTEM
FDA Adverse Event
Malfunction
·CORDIS CORPORATION·Product code NTE·October 22, 2010
FORTIFY ASSURA DR, DF-4 CONNECTOR
FDA Adverse Event
Malfunction
·ST. JUDE MEDICAL INC., CRMD·Product code LWS·January 13, 2014
POWERED WHEELCHAIR
FDA Adverse Event
Malfunction
·INVACARE SUZHOU·Product code ITI·December 19, 2012
Segmental Stem, Canal Filling, Straight, 120MM, 1 EACH. Model Numbers: FS-11120-03M, FS-12120-03M, FS-13120-03M, FS-14120-03M, FS-15120-03M, FS-16120-03M, FS-17120-03M, FS-18120-03M, FS-19120-03M, FS-20120-03M, FS-21120-03M. Component of ELEOS LIMB SALVAGE SYSTEM
FDA Enforcement
Class II
·Ongoing·Onkos Surgical, Inc.·June 4, 2025
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