7 results
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28ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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MIC GASTROSTOMY TUBE
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
CLAVEGUARD FREEDOM SURGICAL LIGHT
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
FUJINON G5 DUODENSCOPES; G5 DUODENOSCOPES, ED-450XT5, ED-250XT5
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
ONETOUCHPING GLUCOSEMGMTSYSTEM
FDA Adverse Event
Malfunction
·ANIMAS CORPORATION·Product code LZG·May 31, 2014
FLOGARD
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE - SINGAPORE·Product code FRN·November 21, 2012
AEROAUTOCAT 2
FDA Adverse Event
Malfunction
·ARROW INTL., INC.·Product code DSP·August 27, 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