7 results
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27ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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12.5MM PEYMAN WIDE FIELD YAG LASER LENS
FDA 510(k)
FDA Class 2
·Ophthalmic
ULTRASONIC NEBULISER MODEL 2010
FDA 510(k)
FDA Class 2
·Anesthesiology
PERITONEAL CYCLER & MANIFOLD SET
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
DA VINCI SI SURGICAL SYSTEM
FDA Adverse Event
Other
·INTUITIVE SURGICAL,INC.·Product code NAY·June 13, 2014
HYPODERMIC NEEDLE-PRO AND NEEDLE WITH NEEDLE PROTECTION DEVICE
FDA Adverse Event
Malfunction
·SMITHS MEDICAL ASD, INC.·Product code CAZ·October 11, 2010
MERIDIAN FILTER SYSTEM - FEMORAL
FDA Adverse Event
Injury
·BARD PERIPHERAL VASCULAR, INC.·Product code DTK·December 5, 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