8 results
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28ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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MCBRIDE MEDIUM CM 819
FDA 510(k)
FDA Class 1
·Microbiology
Patterson
FDA UDI
PATTERSON DENTAL SUPPLY, INC.·D6620708721351·FILE, PULP CANAL, ENDODONTIC
uCT Computed Tomography X-ray System
FDA 510(k)
FDA Class 2
·Radiology
KRONUS GAD AUTOANTIBODY ELISA ASSAY KIT
FDA 510(k)
FDA Class 2
·Immunology
DA VINCI SI SURGICAL SYSTEM
FDA Adverse Event
Injury
·INTUITIVE SURGICAL,INC.·Product code NAY·June 13, 2014
JELCO HYPODERMIC NEEDLE PRO EDGE SAFETY DEVICE
FDA Adverse Event
Malfunction
·SMITHS MEDICAL ASD, INC.·Product code FMI·October 11, 2010
RENU (UNKNOWN TYPE)
FDA Adverse Event
Injury
·BAUSCH & LOMB·Product code LPL·December 4, 2012
PM3544 QUADRA RELIEVE and PM3562 QUADRA ALLURE MP 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