7 results
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22ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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ZINDRICK IM ROD INSTRUMENTS
FDA 510(k)
FDA Class 2
·Orthopedic
Pristine Hemodialysis Catheter
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
DISPOSABLE SYNTHETIC EXAMINATION GLOVES, POWDER FREE
FDA 510(k)
FDA Class 1
·General Hospital
RESERVOIR 1.8ML
FDA Adverse Event
Malfunction
·MEDTRONIC PUERTO RICO OPERATIONS CO.·Product code FRN·June 18, 2014
MINICAP TRANSFER SET
FDA Adverse Event
Injury
·BAXTER HEALTHCARE - MOUNTAIN HOME·Product code KDJ·December 20, 2012
INTERNAL PADDLES OPTION FOR DEFIBRILLATOR/MONITOR
FDA Adverse Event
Malfunction
·PHILIPS HEALTHCARE·Product code MKJ·October 20, 2010
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