8 results
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18ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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SURGICAL VESSEL DILATORS-CATHERIZA-
FDA 510(k)
FDA Class 2
·Cardiovascular
CyFlow™ CD4 PerCP-Cy5.5
FDA UDI
EXBIO Praha, a.s.·08594208066903·The reagent may have application in various tes...
ABX PENTRA MICRO ALB CONTROL L/H
FDA 510(k)
FDA Class 1
·Clinical Chemistry
PALINDROME 14.5 FR CHRONIC HEMODIALYSIS CATHETER
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
ALTRX NEUT 36IDX54OD
FDA Adverse Event
Injury
·DEPUY ORTHOPAEDICS, INC.-1818910·Product code LPH·May 27, 2014
PENTA
FDA Adverse Event
Injury
·ST. JUDE MEDICAL - NEUROMODULATION·Product code LGW·November 12, 2012
CRYSTALENS
FDA Adverse Event
Injury
·BAUSCH + LOMB·Product code NAA·September 10, 2010
Reamer / Irrigator / Aspirator (RIA): RIA Drive Shafts, RIA Tube Assemblies, sterile, RIA Reamer Head, sterile (12.0mm-19.0mm); intended to clear the medullary canal of bone marrow and debris and to effectively size the medullary canal for the acceptance of an intramedullary implant or prosthesis
FDA Enforcement
Class II
·Terminated·Synthes, Inc.·July 22, 2015