7 results
·
20ms
·
Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
×
SERENITY CONTOURED ABSORBENT SHIELDS
FDA 510(k)
FDA Class 1
·Gastroenterology, Urology
SUREFLEX LITHOTRIPSY LASER FIBERS
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
RICH-MAR AUTOPRISM INFRARED LAMP
FDA 510(k)
FDA Class 2
·Physical Medicine
HOMECHOICE
FDA Adverse Event
Injury
·BAXTER HEALTHCARE - LARGO·Product code FKX·May 30, 2014
N/A
FDA Adverse Event
Malfunction
·STRYKER SUSTAINABILITY SOLUTIONS·Product code NLQ·November 20, 2012
ZIMMER TRABECULAR METAL HUMERAL STEM
FDA Adverse Event
Malfunction
·ZIMMER, INC.·Product code HSD·September 17, 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