10 results
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20ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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3M CLINPRO SEALANT
FDA 510(k)
FDA Class 2
·Dental
Autostainer Link 48 (AS480), Autostainer Plus Link Instrument (AS100), Autostainer (S3400), and Autostainer Plus (S3800). Automated slide stainer for in vitro diagnostic use.
FDA Enforcement
Class II
·Terminated·Dako North America Inc.·March 18, 2015
SMOOTHCOOL
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
HardyDisk AST Lefamulin 20µg (LMU20)
FDA 510(k)
FDA Class 2
·Microbiology
NOVATION GXL
FDA Adverse Event
Injury
·EXACTECH, INC.·Product code JDI·September 13, 2022
PROCEED VENTRAL PATCH
FDA Adverse Event
Injury
·ETHICON, INC·Product code FTL·March 7, 2013
SPRINT QUATTRO SECURE
FDA Adverse Event
Malfunction
·MEDTRONIC PUERTO RICO, INC.·Product code LWS·February 15, 2011
SPRINT QUATTRO SECURE
FDA Adverse Event
Malfunction
·MPRI·Product code LWS·August 8, 2014
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