7 results
·
18ms
·
Sources: EU EUDAMED, US FDA
OPHTHALMIC CANNULA
FDA 510(k)
FDA Class 1
·Ophthalmic
P.004 RC CARES TITANIUM AND CERAMIC ABUTMENTS
FDA 510(k)
FDA Class 2
·Dental
Hysteroscopy System
FDA 510(k)
FDA Class 2
·Obstetrics/Gynecology
ACCU-CHEK ® AVIVA PLUS TEST STRIPS
FDA Adverse Event
Malfunction
·ROCHE DIAGNOSTICS·Product code LFR·June 13, 2014
ONE TOUCH PING GLUCOSE MANAGEMENT SYSTEM
FDA Adverse Event
Malfunction
·ANIMAS CORP·Product code LZG·October 12, 2010
ACCU-CHEK ® AVIVA PLUS TEST STRIPS
FDA Adverse Event
Malfunction
·ROCHE DIAGNOSTICS·Product code LFR·December 13, 2012
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