9 results
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24ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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HD-500 Video Endoscope System
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
PRECEPTIS TYMPANOSTOMY TUBE INSERTER
FDA 510(k)
FDA Class 2
·Ear, Nose, Throat
BODYTRONIC 200
FDA 510(k)
FDA Class 2
·Cardiovascular
CAPSUREFIX NOVUS
FDA Adverse Event
Injury
·MPRI·Product code DTB·December 9, 2016
COLLEAGUE PRE P1.7
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE - SINGAPORE·Product code FRN·July 24, 2011
SETROX S 53
FDA Adverse Event
Injury
·BIOTRONIK SE & CO. KG·Product code NVN·June 17, 2013
ALLEGRETTO WAVE EYE-Q
FDA Adverse Event
Injury
·WAVELIGHT GMBH·Product code LZS·October 1, 2014
SUREFORM
FDA Adverse Event
Injury
·INTUITIVE SURGICAL, INC·Product code GDW·July 28, 2020
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