11 results
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21ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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ADVANCE CONTRAST MEDIA SETS (VARYING LENGTH)
FDA 510(k)
FDA Class 2
·General Hospital
Intellijet
FDA UDI
Smith & Nephew, Inc.·00885556600580·O*SOD CANN INTLJT 5.0MM DIAG W/O
...
FLEX DRILL 13G
FDA UDI
G21 SRL·08058964726742·Curette with curved distal end used to create a...
FORA G30 BLOOD GLUCOSE MONITORING SYSTEM, MODEL TD-4241
FDA 510(k)
FDA Class 2
·Clinical Chemistry
EASYRA GLU-T REAGENT, EASYRA GLU-H REAGENT
FDA 510(k)
FDA Class 2
·Clinical Chemistry
2008 HEODIALYSIS SYS. OLC/DIASAFE PLS
FDA Adverse Event
Malfunction
·FRESENIUS MEDICAL CARE NORTH AMERICA·Product code KDI·May 2, 2014
PRECISION®
FDA Adverse Event
Malfunction
·BOSTON SCIENTIFIC NEUROMODULATION·Product code LGW·January 7, 2013
ROUND FLUTED BUR, LONG
FDA Adverse Event
Malfunction
·STRYKER IRELAND LTD.·Product code HBE·October 22, 2010
SMR REVERSE HUMERAL BODY SHORT
FDA Adverse Event
Injury
·LIMACORPORATE S.P.A.·Product code KWS·September 13, 2019
ENF-GP2 Rhino-Laryngo Fiberscope - Product Usage: is indicated for use within the nasal and nasopharyngeal lumen.
FDA Enforcement
Class II
·Terminated·Olympus Corporation of the Americas·June 17, 2020
Plato 17 Microcatheter: Straight Tip, PL17-160-000 ; 45 degree Tip, PL17-160-045; 90 degree Tip, PL17-160-090
FDA Enforcement
Class II
·Ongoing·Scientia Vascular, Inc.·March 22, 2023