5 results
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13ms
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Sources: EU EUDAMED, US FDA
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Status: Ongoing
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GaGa Pro Lighting Equipment Co. Ltd. manufactures Class IV Laser Light Show (LLS)projectors for the purposes of demonstration and entertainment.
FDA Enforcement
Class II
·Ongoing·GAGA PRO LIGHTING EQUIPMENT CO.,·April 5, 2023
HYTEC 288 System, Model 74007P, automated immunoanalyzer (EIA) instrument. For in vitro diagnostic use only. HYTEC AUTOSTAT II RF assays: HYTEC AUTOSTAT II RF IgM Kit: Part Number FGA 05, HYTEC AUTOSTAT II RF IgA Kit: Part Number FGA 06, HYTEC AUTOSTAT II RF IgG Kit: Part Number FGA 07, HYTEC AUTOSTAT II Total Rheumatoid Factor Kit: Part Number FGA 08.
FDA Enforcement
Class II
·Ongoing·Hycor Biomedical Inc·August 14, 2019
Medtronic Aortic Root Cannulae and Cardioplegia Needles: a) DLP¿ 9 Ga (11 Fr) Aortic Root Cannula, Model Number 24009; b) DLP¿ 16 Ga (5 Fr) Cardioplegia Needle Neonatal 0.64 cm (1/4 in) Tip Length, Model Number 11316; c) M+AR" 14 Ga (7 Fr) Aortic Root Cannula with Flow-Guard", Model Number 11014L
FDA Enforcement
Class II
·Ongoing·Medtronic Perfusion Systems·May 22, 2024
MINISCAV (tm) Vacuum Pump
FDA Enforcement
Class II
·Ongoing·R A Medical Services·September 27, 2023
FloPatch FP120, REF: FP120-FOT01-005
FDA Enforcement
Class III
·Ongoing·Flosonics Medical (R/A 1929803 ONTARIO CORP.)·September 10, 2025