11 results
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25ms
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Sources: EU EUDAMED, US FDA
THIOGLYCOLLATE ENRICHED
FDA 510(k)
FDA Class 1
·Microbiology
KORONA
FDA UDI
HNM TOTAL RECON LLC·00841742100708·KORONA Tri Staple - (L)12.5mm, 10mmx8mm
Partial Pelvis Replacement
FDA UDI
WALDEMAR LINK GmbH & Co. KG·04026575048434·5 hole flanges
KEYPATH MRSA/MSSA BLOOD CULTURE TEST-BT
FDA 510(k)
FDA Class 1
·Microbiology
MEDAMICUS AXIA RSN
FDA 510(k)
FDA Class 2
·Cardiovascular
ANIMAS INSULIN INFUSION PUMP
FDA Adverse Event
Malfunction
·ANIMAS CORPORATION·Product code LZG·May 20, 2014
ENDO RETRACT II 10MM INSTRUMENT
FDA Adverse Event
Malfunction
·COVIDIEN, FORMERLY USSC·Product code GCJ·October 4, 2012
CAPSURE EPI
FDA Adverse Event
Injury
·MEDTRONIC, INC.·Product code DTB·August 31, 2010
BioGX SARS-CoV-2 Reagents for BD MAX System-IVD PCR test intended for the qualitative detection of nucleic acid from the SARS-CoV-2 in nasopharyngeal specimens Catalog Number: 444213
FDA Enforcement
Class II
·Terminated·Becton Dickinson & Co.·April 21, 2021
PM 1250 and PM 2250 ZENEX; PM1282 and PM2282 ZENEX MRI 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
PM 1260 ASSURITY + 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