FDA warning

FDA Building 2
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 headquarters

Medtronic’s diabetes HQ receives FDA warning letter

Dec 15, 2021 9:50am
FDA Building 2

Owlet pulls baby-monitoring Smart Sock after FDA warning

Nov 29, 2021 3:55pm
FDA

FDA adds new restrictions, warning labels for breast implants

Oct 28, 2021 12:23pm
FDA Building 2

FDA warns against using needle-free devices for facial fillers

Oct 11, 2021 11:56am
Gilead

Chasing AbbVie, Gilead files for approval of filgotinib in Japan

Oct 8, 2019 8:22am