7 results
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18ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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FISCH MODIFIED TOTAL OSSICULAR PROSTHES
FDA 510(k)
FDA Class 2
·Ear, Nose, Throat
EXTRA LARGE BODY COIL
FDA 510(k)
FDA Class 2
·Radiology
XOFT AXXENT CERVICAL APPLICATORS
FDA 510(k)
FDA Class 2
·Radiology
LFIEVEST WCD 4000 SYSTEM
FDA Adverse Event
Malfunction
·ZOLL LIFECOR CORPORATION·Product code MVK·May 1, 2014
ERYTYPECELL-B
FDA Adverse Event
Malfunction
·BIO-RAD MEDICAL DIAGNOSTICS GMBH·Product code KSZ·November 8, 2012
WALLFLEX ESOPHAGEAL FULLY COVERED STENT SYSTEM
FDA Adverse Event
Injury
·BOSTON SCIENTIFIC - GALWAY·Product code ESW·September 2, 2010
Allura Exper FD Series. System codes 722003 722010 722022 722005 722011 722019 722001 722002 722006 722012 722008 722013 722020 722025 722015 722023 722038 889006 889016 889009 722005 The device is an X-Ray Generator.
FDA Enforcement
Class II
·Terminated·Philips North America, LLC·March 25, 2020