Radiometer Medicals Aps FDA Approvals

0 new drug approvals and 5 device clearances on file. This applicant is not matched to a listed company.

Newest first

A new drug approval is an original application; a 510(k) is a device shown equivalent to one already sold.

Product	What it is	Route	Decided
ABL90 FLEX PLUS System510(k)May 1, 2026Clinical Chemistry	Clinical Chemistry	510(k)Substantially Equivalent (Traditional)	May 1, 2026
ABL90 FLEX PLUS System510(k)May 1, 2026Clinical Chemistry	Clinical Chemistry	510(k)Substantially Equivalent (Traditional)	May 1, 2026
ABL90 FLEX PLUS System, safeCLINITUBES510(k)Apr 10, 2026Clinical Chemistry	Clinical Chemistry	510(k)Substantially Equivalent (Traditional)	Apr 10, 2026
ABL90 FLEX PLUS System510(k)Jan 14, 2025Clinical Chemistry	Clinical Chemistry	510(k)Substantially Equivalent (Traditional)	Jan 14, 2025
ABL90 FLEX PLUS System510(k)Dec 13, 2024Clinical Chemistry	Clinical Chemistry	510(k)Substantially Equivalent (Traditional)	Dec 13, 2024