7 results
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19ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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TRACHEOTOMY TUBES
FDA 510(k)
FDA Class 2
·Anesthesiology
MODIFICATION TO GFX NERVE ABLATION SYSTEM
FDA 510(k)
FDA Class 2
·Neurology
17-HYDROXYPROGESTERONE TEST SET
FDA 510(k)
FDA Class 1
·Clinical Chemistry
CURRENT RF DR
FDA Adverse Event
Injury
·ST. JUDE MEDICAL, INC., CRMD·Product code LWS·April 30, 2014
FREESTYLE FLASH
FDA Adverse Event
Malfunction
·ABBOTT DIABETES CARE INC, USA·Product code LFR·June 19, 2007
SPRINT
FDA Adverse Event
Injury
·MEDTRONIC PUERTO RICO, INC.·Product code LWS·October 11, 2012
PROPONENT DR SL (Model L201)
FDA Enforcement
Class I
·Ongoing·Boston Scientific Corporation·October 22, 2025