7 results
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21ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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MANAN SELDINGER NEEDLE
FDA 510(k)
FDA Class 1
·Cardiovascular
TSX-101A/H AQUILION 64 SP CT SCANNER; TSX-101A/I AQUILION 32 SP CT SCANNER
FDA 510(k)
FDA Class 2
·Radiology
Aquilion Lightning (TSX-035A/2, V7.0)
FDA 510(k)
FDA Class 2
·Radiology
MICRO INCISION VACUUM PHACO PACK
FDA Adverse Event
Malfunction
·BAUSCH & LOMB·Product code HQC·April 11, 2014
ENDOTAK DSP
FDA Adverse Event
Malfunction
·CPI - DEL CARIBE·Product code NVY·October 4, 2010
PK DISSECTING FORCEPS INSTRUMENT
FDA Adverse Event
Malfunction
·INTUITIVE SURGICAL,INC.·Product code NAY·November 29, 2012
GLOBAL UNITE STD STEM SZ 14 Product Code: 110014100
FDA Enforcement
Class II
·Terminated·DePuy Orthopaedics, Inc.·January 19, 2022