Ascensia Diabetes Care U.S., Inc. 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
MICROLET®NEXT 2 Lancing Device510(k)May 14, 2025General, Plastic Surgery	General, Plastic Surgery	510(k)Substantially Equivalent (Traditional)	May 14, 2025
CONTOUR® PLUS BLUE Blood Glucose Monitoring System; CONTOUR® NEXT GEN Blood Glucose Monitoring System510(k)Aug 27, 2024Clinical Chemistry	Clinical Chemistry	510(k)Substantially Equivalent (Traditional)	Aug 27, 2024
MICROLET®NEXT Lancet510(k)Aug 15, 2024General, Plastic Surgery	General, Plastic Surgery	510(k)Substantially Equivalent (Traditional)	Aug 15, 2024
CONTOUR® NEXT GEN Blood Glucose Monitoring System510(k)Nov 18, 2022Clinical Chemistry	Clinical Chemistry	510(k)Substantially Equivalent (Special)	Nov 18, 2022
MICROLET NEXT lancing device, MICROLET Lancet510(k)Jun 3, 2022General, Plastic Surgery	General, Plastic Surgery	510(k)Substantially Equivalent (Traditional)	Jun 3, 2022