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FDA warning
MedTech
FDA cracks down on use of unauthorized LuSys COVID tests
LuSys' antigen and antibody tests haven’t received clearance or authorization and carry a “high risk” of returning incorrect results, the FDA said.
Andrea Park
Jan 12, 2022 9:40am
Medtronic’s diabetes HQ receives FDA warning letter
Dec 15, 2021 9:50am
Owlet pulls baby-monitoring Smart Sock after FDA warning
Nov 29, 2021 3:55pm
FDA adds new restrictions, warning labels for breast implants
Oct 28, 2021 12:23pm
FDA warns against using needle-free devices for facial fillers
Oct 11, 2021 11:56am
Chasing AbbVie, Gilead files for approval of filgotinib in Japan
Oct 8, 2019 8:22am