8 results
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23ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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NEBULIZER NO. M-175
FDA 510(k)
FDA Class 2
·Anesthesiology
Revitive Medic Plus, Revitive Advanced 2
FDA 510(k)
FDA Class 2
·Physical Medicine
TUCKS POLYPAD MATERNITY CARE PAD
FDA 510(k)
FDA Class 1
·Obstetrics/Gynecology
NUCLEUS 24 CHANNEL COCHLEAR IMPLANT SYSTEM
FDA Adverse Event
Injury
·COCHLEAR LTD.·Product code MCM·May 5, 2014
VIRTUOSO VR
FDA Adverse Event
Injury
·MEDTRONIC S.A.·Product code LWS·October 15, 2012
STARCLOSE SE VASCULAR CLOSURE SYSTEM
FDA Adverse Event
Death
·ABBOTT VASCULAR - REDWOOD CITY·Product code MGB·July 30, 2010
Heritage Labs Appraise A1c Diabetes Home Test , Product K7609, 24 kits/shipping carton (Product K7609), each kit packed in a box and contains 1 Triad Medium Alcohol Prep Pad, Cat. No. 10-3001, NDC 50730-3001-0, and blood specimen collection supplies, forms, and instructions Blood specimen collection
FDA Recall
Terminated
·Heritage Labs International LLC·Product code LCP·January 9, 2011
Promote Quadra, Sterile EO, Model # / Part #: CD3221-36/100025054, 60019195; CD3223-36P/100013763; CD3239-40/100029115, 100029254, 100037181; CD3239-40Q/100029116, 100029244, 100037115
FDA Enforcement
Class II
·Terminated·St Jude Medical Inc.·July 4, 2018