11 results
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22ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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Color Liquid, Vita Liquid
FDA 510(k)
FDA Class 2
·Dental
LinkBio Instrument
FDA UDI
Link Bio Corp·00810022402276·Guide Rod, Tibial Cone, D 18/120 L
INSTRUMED VESSEL DILATORS, MODEL 65-7XX,65-9XXX,66-1XXX,65-7048-65-7054
FDA 510(k)
FDA Class 2
·Cardiovascular
QUART ARTERIAL FILTER WITH SOFTLINE COATING
FDA 510(k)
FDA Class 2
·Cardiovascular
LONG NAIL KIT R1.5, TI, LEFT GAMMA3 10X320MM X 12
FDA Adverse Event
Injury
·STRYKER OSTEOSYNTHESIS KIEL·Product code HSB·July 19, 2012
I-STAT EC8+ CARTRIDGE
FDA Adverse Event
Malfunction
·ABBOTT POINT OF CARE·Product code CHL·May 16, 2019
PICC KIT 2-LUMEN: 5 FR X 19-5/8IN (50CM)
FDA Adverse Event
Malfunction
·ARROW INTL., INC.·Product code LJS·June 21, 2013
PROMUS ELEMENT ¿ LONG
FDA Adverse Event
Malfunction
·BOSTON SCIENTIFIC - GALWAY·Product code NIQ·August 4, 2011
PARADIGM REAL-TIME INSULIN INFUSION PUMP
FDA Adverse Event
Malfunction
·MEDTRONIC MINIMED·Product code OYC·October 21, 2014
MEDTRONIC
FDA Adverse Event
Injury
·MEDTRONIC, INC.·Product code DXY·May 22, 2020
cobas 6000 analyzer series Operators Manual Roche cobas; Filter label: Filter (N) Mat. No 03149773001, Contents 1, 768-320 Filter (N) Product Usage: Fully automated immunoassay analyzer intended for the in-vitro quantitative/qualitative determination of analytes in body fluids.
FDA Enforcement
Class II
·Terminated·Roche Diagnostics Operations, Inc.·June 25, 2014