ClearanceBrief
Company · US

Ascensia Diabetes Care U.S., Inc.

FDA 510(k) clearances and medical device recalls filed under this name, 2016 to 2025. Name variants (Inc, Corp, punctuation) are merged.

7510(k) clearances (0 in 12 months)
0recalls (0 in 12 months)
0recalls that name a 510(k)

Product codes

CodeDeviceRecords
NBWSystem, Test, Blood Glucose, Over The Counter4
QRLMultiple Use Blood Lancet For Single Patient Use Only2
QRKSingle Use Only Blood Lancet Without An Integral Sharps Injury Prevention Feature1

Latest 510(k) clearances

Decided510(k)Device and applicantCode
May 14, 2025K250813MICROLET®NEXT 2 Lancing Device
Ascensia Diabetes Care U.S., Inc.
QRL
Aug 27, 2024K241787CONTOUR® PLUS BLUE Blood Glucose Monitoring System; CONTOUR® NEXT GEN Blood Glucose Monitoring System
Ascensia Diabetes Care U.S., Inc.
NBW
Aug 15, 2024K241810MICROLET®NEXT Lancet
Ascensia Diabetes Care U.S., Inc.
QRK
Nov 18, 2022K223293CONTOUR® NEXT GEN Blood Glucose Monitoring System
Ascensia Diabetes Care U.S., Inc.
NBW
Jun 3, 2022K220633MICROLET NEXT lancing device, MICROLET Lancet
Ascensia Diabetes Care U.S., Inc.
QRL
Jan 12, 2017K162336Contour Next EZ Blood Glucose Monitoring System
Ascensia Diabetes Care U.S., Inc.
NBW
Jun 24, 2016K160430Contour Next Link Wireless Blood Glucose Monitoring System, Contour Next Blood Glucose Monitoring System
Ascensia Diabetes Care U.S., Inc.
NBW

Latest recalls

DateFirm and productCodeLinked 510(k)
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