Ascensia Diabetes Care U.S., Inc.

FDA Regulatory Profile

Ascensia Diabetes Care U.S., Inc. appears in FDA public data with 0 recalls, 7 510(k) clearances, 4 FDA inspections, and 0 compliance actions on record. Its most recent 510(k) clearance was granted on May 14, 2025.

Summary

Total Recalls
0
510(k) Clearances
7
Inspections
4
Compliance Actions
0

Known Names

ascensia diabetes care us, ascensia diabetes care u.s

Recent 510(k) Clearances

K-NumberDeviceDate
K250813MICROLET®NEXT 2 Lancing DeviceMay 14, 2025
K241787CONTOUR® PLUS BLUE Blood Glucose Monitoring System; CONTOUR® NEXT GEN Blood Glucose Monitoring SysteAugust 27, 2024
K241810MICROLET®NEXT LancetAugust 15, 2024
K223293CONTOUR® NEXT GEN Blood Glucose Monitoring SystemNovember 18, 2022
K220633MICROLET NEXT lancing device, MICROLET LancetJune 3, 2022
K162336Contour Next EZ Blood Glucose Monitoring SystemJanuary 12, 2017
K160430Contour Next Link Wireless Blood Glucose Monitoring System, Contour Next Blood Glucose Monitoring SyJune 24, 2016