9 results
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25ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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LYPHOCHEK ASSAYED CHEMISTRY CONTROL
FDA 510(k)
FDA Class 1
·Clinical Chemistry
MEDI
FDA UDI
MEDI MANUFACTURING, INC.·00636257127704·15-20 MV FOR MEN SEL EW CLF STD GREY III
MEDI
FDA UDI
MEDI MANUFACTURING, INC.·00636257128800·15-20 MV FOR MEN CLSC EW STD GREY III
SCREENERS OPIATES TEST DRUGSCREEN DIP OPIATES TEST
FDA 510(k)
FDA Class 2
·Clinical Toxicology
CRANIAL MOLDING ORTHOSIS
FDA 510(k)
FDA Class 2
·Neurology
PROLIFT PELVIC FLOOR REPAIR
FDA Adverse Event
Injury
·ETHICON SARL A JOHNSON & JOHNSON COMPANY·Product code FTL·April 5, 2011
LIBERTY CYCLER SET, SINGLE CONN/EXT DL
FDA Adverse Event
Malfunction
·REYNOSA MANUFACTURING·Product code FKX·April 3, 2013
SYNCHROMED II
FDA Adverse Event
Injury
·MEDTRONIC NEUROMODULATION·Product code LKK·May 8, 2008
Medfusion Syringe Pump, Model 4000. The Model 4000 pump is a small, lightweight and portable syringe infusion pump. The pump offers a variety of delivery modes programmable to meet specific patient care needs.
FDA Enforcement
Class I
·Terminated·Smiths Medical ASD Inc.·December 18, 2019