7 results
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34ms
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Sources: EU EUDAMED, US FDA
BISFIL-I LIGHT CURABLE POSTERIOR COMPO
FDA 510(k)
FDA Class 2
·Dental
COVA MONITORING SYSTEM
FDA 510(k)
FDA Class 2
·Cardiovascular
BABYBIRD 2 VENTILATOR
FDA 510(k)
FDA Class 2
·Anesthesiology
MINICAP TRANSFER SET
FDA Adverse Event
Injury
·BAXTER HEALTHCARE - MOUNTAIN HOME·Product code KDJ·May 31, 2014
ACCU-CHEK ® PERFORMA TEST STRIPS
FDA Adverse Event
Injury
·ROCHE DIAGNOSTICS·Product code LFR·November 21, 2012
SYNCHROMED II
FDA Adverse Event
Injury
·MDT PUERTO RICO OPERATIONS CO., JUNCOS·Product code LKK·September 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