7 results
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35ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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DIDECO-SHILEY WASTE COLLECTION BAG
FDA 510(k)
FDA Class 2
·Anesthesiology
AQUA PURE DEIONIZER EXCHANGE SERVICE
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
LIGHT-PEN SYSTEM FOR QUANTI. ANALY.
FDA 510(k)
FDA Class 2
·Cardiovascular
KNEE REPLACEMENT
FDA Adverse Event
Injury
·STRYKER·Product code JDI·June 12, 2014
MX-PRO AMBULANCE COT
FDA Adverse Event
Malfunction
·STRYKER CORP., MEDICAL DIV.·Product code FPO·October 12, 2010
UNKNOWN HIP STEM
FDA Adverse Event
Injury
·STRYKER ORTHOPAEDICS MAHWAH·Product code MEH·December 6, 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