12 results
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21ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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PRO2 CHECK OXYGEN INDICATOR
FDA 510(k)
FDA Class 2
·Anesthesiology
DeRoyal
FDA UDI
DEROYAL INDUSTRIES, INC.·00749756024785·ELASTIC BANDAGE
GLUCOSE-SUPER FAST 4983050 AND 4983500
FDA 510(k)
FDA Class 2
·Clinical Chemistry
MCCOY'S 5A MEDIUM 10X NO. 210-3532
FDA 510(k)
FDA Class 1
·Hematology
MEDILAS D FAMILY LASERS, INCLUDING MEDILAS D LITEBEAM, LITEBEAM +, UROBEAM, MULTIBEAM, FLEXIPULSE AND MAGNAPULSE
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
PRECISION XTRA
FDA Adverse Event
Malfunction
·ABBOTT DIABETES CARE INC.·Product code CGA·July 27, 2016
RADICAL DOCKING STATION
FDA Adverse Event
Malfunction
·MASIMO CORPORATION·Product code DQA·June 26, 2014
FUSION NAVIGATION SYSTEM
FDA Adverse Event
Malfunction
·MEDTRONIC NAVIGATION, INC.·Product code HAW·February 28, 2013
ETS FLEX ARTICNG LNR
FDA Adverse Event
Malfunction
·ETHICON ENDO-SURGERY, LLC.·Product code GDW·February 10, 2011
PRECISION XTRA
FDA Adverse Event
Malfunction
·ABBOTT DIABETES CARE INC·Product code NBW·October 19, 2016
PRECISION XTRA
FDA Adverse Event
Malfunction
·ABBOTT DIABETES CARE INC·Product code NBW·July 26, 2016
GORE® TAG® THORACIC ENDOPROSTHESIS
FDA Adverse Event
Death
·W.L. GORE & ASSOCIATES·Product code MIH·October 12, 2016