8 results
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20ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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ARTHROSCOPIC TELESCOPES
FDA 510(k)
FDA Class 2
·Orthopedic
Eye Secret 38 UV Aspheric Color(polymacon) Soft(hydrophilic) Contact Lens for Daily;Eye Secret 38 UV Aspheric Color(polymacon) 1-Day Soft(hydrophilic) Contact Lens
FDA 510(k)
FDA Class 2
·Ophthalmic
TRIGEN HINDFOOT FUSION NAIL
FDA 510(k)
FDA Class 2
·Orthopedic
NV GXL LINR, NTRL, 32MM ID, GROUP 2 CUPS
FDA Adverse Event
Injury
·EXACTECH, INC.·Product code JDI·October 12, 2023
ACCU-CHEK SPIRIT
FDA Adverse Event
Malfunction
·ROCHE HEALTH SOLUTIONS INC.·Product code LZG·January 18, 2013
OT PING METER
FDA Adverse Event
Malfunction
·LIFESCAN INC.·Product code NBW·December 30, 2010
PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP
FDA Adverse Event
Malfunction
·MEDTRONIC PUERTO RICO OPERATIONS CO.·Product code OYC·July 17, 2014
ev3 Pipeline Flex Embolization Device with Shield Technology. Sold OUS. For neurological endovascular use.
FDA Enforcement
Class I
·Terminated·Micro Therapeutics Inc, Dba Ev3 Neurovascular·April 1, 2020