9 results
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28ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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INSULIN RADIOIMMUNOASSAY KIT
FDA 510(k)
FDA Class 1
·Clinical Chemistry
Deltaven Fast Flash
FDA UDI
DELTA MED SPA·08032248005419·Safety IV catheter in PUR with closed system, d...
SILVERLON ISLAND WOUND DRESSING
FDA 510(k)
FDA Unclassified
·Unknown
NANMA VACUUM PUMP PROXZEK MODEL 2M9498S
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
SET, ADMINISTRATION, FOR PERITONEAL DIALYSIS, DISPOSABLE
FDA Adverse Event
Injury
·BAXTER HEALTHCARE CORPORATION·Product code KDJ·May 30, 2014
ST104 TRANSPORT
FDA Adverse Event
Malfunction
·STRYKER MEDICAL·Product code FPO·October 24, 2012
HEARTSTART MRX - EMS DEFIBRILLATOR
FDA Adverse Event
Malfunction
·PHILIPS HEALTHCARE·Product code MKJ·September 17, 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
PM1214 NUANCE SR RF; PM1230 and PM2230 NUANCE MRI; PM2214 NUANCE DR RF 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