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Bardy Diagnostics, Inc.

FDA Regulatory Profile

Summary

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

Recent 510(k) Clearances

K-NumberDeviceDate
K233110Carnation Ambulatory MonitorNovember 22, 2023
K210036Carnation Ambulatory Monitor (CAM)February 5, 2021
K200870Carnation Ambulatory MonitorMay 1, 2020
K192556Carnation Ambulatory MonitorOctober 17, 2019
K191471Carnation Ambulatory MonitorAugust 30, 2019
K191000Carnation Ambulatory MonitorMay 16, 2019
K143067Carnation Ambulatory MonitorDecember 22, 2014