Roche Diabetes Care, Inc. is one of 5511 FDA 510(k) medical device manufacturers from United States in the dataset, ranked by real submission volume.
Roche Diabetes Care, Inc. - FDA 510(k) Cleared Devices
Recent clearances: Accu-Chek Safe-T-Pro Plus Lancing Device, Accu-Chek Safe-T-Pro Uno Lancing Device, Accu-Chek Safe-T-Pro Plus Lancing Device
9
Total
9
Cleared
0
Denied
Roche Diabetes Care, Inc. has 9 FDA 510(k) cleared medical devices. Based in Indianapolis,, US.
Last cleared in 2023. Active since 2015. Primary specialty: General & Plastic Surgery.
Browse the FDA 510(k) cleared devices submitted by Roche Diabetes Care, Inc. Filter by specialty or product code using the sidebar.
FDA 510(k) Regulatory Record - Roche Diabetes Care, Inc.
9 devices
Cleared
Nov 13, 2023
Accu-Chek Safe-T-Pro Plus Lancing Device
General & Plastic Surgery
88d
Cleared
Nov 13, 2023
Accu-Chek Safe-T-Pro Uno Lancing Device
General & Plastic Surgery
87d
Cleared
May 19, 2022
Accu-Chek Safe-T-Pro Plus Lancing Device
General & Plastic Surgery
57d
Cleared
May 06, 2022
IWL2020 Blood Glucose Monitoring System
Chemistry
501d
Cleared
Apr 29, 2022
Accu-Chek FastClix Blood Lancing System
General & Plastic Surgery
58d
Cleared
Apr 05, 2022
Accu-Chek Safe-T-Pro Uno Lancing Device
General & Plastic Surgery
56d
Cleared
Feb 17, 2022
Accu-Chek Softclix Blood Lancing System
General & Plastic Surgery
57d
Cleared
Aug 31, 2016
ACCU-CHEK Guide Blood Glucose Monitoring System
Chemistry
148d
Cleared
Jun 03, 2015
ACCU-CHEK Connect Diabetes Management App
General Hospital
61d