8 results
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24ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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MURDOCH LAPAROSCOPE LENS CLEANER
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
MARK3
FDA 510(k)
FDA Class 2
·Dental
FAST START TENS, MODEL FS 3001
FDA 510(k)
FDA Class 2
·Neurology
X SERIES
FDA Adverse Event
Malfunction
·ZOLL MEDICAL CORPORATION·Product code MKJ·April 24, 2014
HS III PROXIMAL SEAL SYSTEM 4.3MM
FDA Adverse Event
Malfunction
·MAQUET CARDIOVASCULAR, LLC·Product code DXC·January 16, 2013
ACCU-CHEK SPIRIT
FDA Adverse Event
Malfunction
·ROCHE INSULIN DELIVERY SYSTEMS INC.·Product code LZG·December 8, 2010
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
Allura Exper FD Series. System codes 722003 722010 722022 722005 722011 722019 722001 722002 722006 722012 722008 722013 722020 722025 722015 722023 722038 889006 889016 889009 722005 The device is an X-Ray Generator.
FDA Enforcement
Class II
·Terminated·Philips North America, LLC·March 25, 2020