7 results
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19ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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PTI HEART-LIFT(TM) CARDIAC RETRACTION GLOVES-STERI
FDA 510(k)
FDA Class 1
·General, Plastic Surgery
Wilson-Cook Mini Basket
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
GENEX
FDA 510(k)
FDA Class 2
·Orthopedic
PRECISION®
FDA Adverse Event
Injury
·BOSTON SCIENTIFIC NEUROMODULATION·Product code LGW·June 18, 2014
SETROX S 53
FDA Adverse Event
Injury
·BIOTRONIK SE & CO, KG·Product code NVZ·October 22, 2010
FOOT CONTROL IPC REFURB
FDA Adverse Event
Malfunction
·XOMED MFG JACKSONVILLE·Product code ERL·December 20, 2012
Minor Pack and Minor Pack II Pack - contains Devon Light Glove Used during surgery
FDA Enforcement
Class II
·Completed·Stradis Healthcare, LLC.·July 15, 2015