9 results
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18ms
·
Sources: EU EUDAMED, US FDA
LAPARETTE
FDA 510(k)
FDA Class 2
·Obstetrics/Gynecology
Millennium
FDA UDI
Avalign Technologies, Inc.·00190776164324·Nail Nippers Concave Folding Spring . SS
Sklar
FDA UDI
SKLAR CORPORATION·10649111038907·NAIL NIP CNCV FOLD SPRG 4.5 SS
Arrow Seldinger Arterial Catheterization Device 18 ga., Arrow Seldinger Arterial Catheterization Device 20 ga., Arrow Seldinger Arterial Catheterization Device 22 ga., Arrow Seldinger Arterial Catheterization Device 24 ga.
FDA 510(k)
FDA Class 2
·Cardiovascular
VIDAS B.R.A.H.M.S. PCT ASSAY
FDA 510(k)
FDA Class 2
·Microbiology
ACHIEVA PLUS
FDA Adverse Event
Malfunction
·COVIDIEN, FORMERLY NELLCO·Product code CBK·February 1, 2013
PRECISION XTRA
FDA Adverse Event
Malfunction
·Product code NBW·January 26, 2011
ONETOUCHPING GLUCOSEMGMTSYSTEM
FDA Adverse Event
Malfunction
·ANIMAS CORPORATION·Product code LZG·July 31, 2014
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