8 results
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19ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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RADIFOCUS(R) (CATHETER) GUIDE WIRE
FDA 510(k)
FDA Class 2
·Cardiovascular
Summit Moldable
FDA UDI
Biogennix, LLC·00812593021948·Summit Moldable 2.5cc
BARTELS PRIMA SYSTEM ADVANCED SCREENING CARTRIDGE
FDA 510(k)
FDA Class 1
·Clinical Chemistry
LATEX EXAM/SURGICAL GLOVES
FDA 510(k)
FDA Class 1
·General Hospital
CONSULTA
FDA Adverse Event
Injury
·MEDTRONIC MED REL, INC.·Product code NIK·December 14, 2010
S-ROM*SLEEVE PRX ZTT, 18D-SML
FDA Adverse Event
Injury
·DEPUY ORTHOPAEDICS, INC. - 1818910·Product code LPH·January 22, 2013
TENDRIL SDX
FDA Adverse Event
Malfunction
·ST. JUDE MEDICAL, INC., CRMD·Product code DTB·July 9, 2014
9310HD Digital Video Capture Modules Product Usage: The 9310HD is used to electronically record, display, transfer, and store digital video data of laryngeal or pharyngeal structures, and audio data, for medical and pedagogical applications.
FDA Enforcement
Class II
·Terminated·Pentax of America Inc·July 26, 2017