7 results
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18ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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CRITIKON I.V. FILTER
FDA 510(k)
FDA Class 2
·General Hospital
BI-FUNNEL GASTROSTOMY FEEDING TUBE, TRI-FUNNEL GASTROSTOMY FEEDING TUBE
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
QUILL SYNTHETIC ABSORBABLE BARBED SUTURE
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
ONETOUCHPING GLUCOSEMGMTSYSTEM
FDA Adverse Event
Malfunction
·ANIMAS CORPORATION·Product code LZG·May 31, 2014
ALARIS PUMP MODULE
FDA Adverse Event
Injury
·CAREFUSION CORP.·Product code FRN·November 14, 2012
NA
FDA Adverse Event
Malfunction
·ARROW INTL., INC.·Product code LJS·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