7 results
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19ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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ANTI-SKIN ANTIBODY TEST(MONKEY ESOPHAGUS SECTIONS)
FDA 510(k)
FDA Class 2
·Immunology
KOWAGENESIS-DF
FDA 510(k)
FDA Class 2
·Ophthalmic
SINGLE-USE MINI-BULLDOG
FDA 510(k)
FDA Class 2
·Cardiovascular
CONSTELLATION WITH LASER
FDA Adverse Event
Malfunction
·ALCON - IRVINE TECHNOLOGY CENTER·Product code HQC·October 22, 2010
SPECTRUM INFUSION PUMP
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE CORP·Product code FRN·January 31, 2014
NEPTUNE ROVER WITH SMOKE EVAC AND POWER POLE
FDA Adverse Event
Malfunction
·STRYKER INSTRUMENTS KALAMAZOO·Product code FYD·November 14, 2012
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