7 results
·
18ms
·
Sources: EU EUDAMED, US FDA
OPTEC 2300 AFVT, ARMED FORCES VISION TESTER
FDA 510(k)
FDA Class 1
·Ophthalmic
PERKIN-ELMER AA 3100 ATOMIC ABSORPTION SPECTRO.
FDA 510(k)
FDA Class 1
·Clinical Chemistry
SUTURE REMOVAL TRAY
FDA 510(k)
FDA Class 1
·General, Plastic Surgery
ADULT INSPIRATORY-HEATED BREATHING CIRCUIT
FDA Adverse Event
Malfunction
·FISHER & PAYKEL HEALTHCARE LTD·Product code BTT·November 22, 2010
ADVANTAGE SYSTEM
FDA Adverse Event
Injury
·BOSTON SCIENTIFIC - MARLBOROUGH·Product code FTL·January 9, 2013
TELIGEN
FDA Adverse Event
Injury
·GUIDANT CRM CLONMEL IRELAND·Product code LWP·July 1, 2014
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