9 results
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29ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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Diagnostic Ultrasound System
FDA 510(k)
FDA Class 2
·Radiology
AccuQuest
FDA UDI
Bernafon AG·05711584089491·AQ CO1 MNR T, 2.4G NFM DPB ANBR ACCUQ
EASYSUITE SURGICAL LIGHT CONTROL (ESLC)
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
KNEEHAB XP CONTROLLER, MODEL 411
FDA 510(k)
FDA Class 2
·Physical Medicine
DURACON UNIVERSAL B/P NON-BEADED
FDA Adverse Event
Injury
·STRYKER ORTHOPAEDICS MAHWAH·Product code JDI·October 8, 2008
URETEX SUP URETHRAL SUPPORT SYSTEM
FDA Adverse Event
Injury
·SOFRADIM PRODUCTION·Product code FTL·May 1, 2013
CVC SET: 2-LUMEN 12 FR X 20 CM
FDA Adverse Event
Malfunction
·ARROW INTL., INC.·Product code DQO·July 20, 2011
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
DuraLife Autoclavable Double Swivel Elbow, REF 60-0010 (UltraSet Product Code 66-1991); Swivel Elbow with Suction Port for use with breathing circuits
FDA Enforcement
Class II
·Ongoing·Smiths Medical ASD Inc.·May 24, 2023