9 results
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20ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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Evis Exera III Colonovideoscope Olympus PCF-H190TL, Evis Exera III Colonovideoscope Olympus PCF-H190TI, Evis Exera III Colonovideoscope Olympus PCF-HQ190L, Evis Exera III Colonovideoscope Olympus PCF-HQ190I
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
AccuQuest
FDA UDI
Bernafon AG·05711584087718·AQ CO3 B 105, 2.4G NFM DPB MSIL ACCUQ
LIAISON TESTOSTERONE; LIAISON TESTOSTERONE CONTROL SET
FDA 510(k)
FDA Class 1
·Clinical Chemistry
MODIFICATION TO:KNEEHAB XP CONDUCTIVE GARMENT, MODEL 411
FDA 510(k)
FDA Class 2
·Neurology
RHYTHMIA HDX
FDA Adverse Event
Malfunction
·BOSTON SCIENTIFIC CORPORATION·Product code DQK·October 16, 2025
NXSTAGE SYSTEM ONE
FDA Adverse Event
Injury
·NXSTAGE MEDICAL, INC.·Product code KDI·October 8, 2008
AUTOCAT2 WAVE
FDA Adverse Event
Malfunction
·ARROW INTL., INC.·Product code DSP·July 20, 2011
AVAULTA POSTERIOR BIOSYNTHETIC SUPPORT SYSTEM
FDA Adverse Event
Injury
·SOFRADIM PRODUCTION·Product code FTL·May 2, 2013
Dragonfly OpStar Imaging Catheter, REF 1014651/1014652, 0.068 in, 0.014 in, 135 cm, STERILE EO
FDA Enforcement
Class I
·Ongoing·Abbott Vascular·May 25, 2022