Zywie, Inc. is one of 16306 FDA 510(k) medical device manufacturers from United States in the dataset, ranked by real submission volume.
Zywie, Inc. - FDA 510(k) Cleared Devices
Recent clearances: ZywieZ3 Sensor & Adhesive, ZywieAI Software Library
2
Total
2
Cleared
0
Denied
Zywie, Inc. has 2 FDA 510(k) cleared medical devices. Based in Johns Creek, US.
Latest FDA clearance: Jun 2026. Active since 2015. Primary specialty: Cardiovascular.
Browse the FDA 510(k) cleared devices submitted by Zywie, Inc. Filter by specialty or product code using the sidebar.
510(k) submissions have been managed by Ajw Technology Consultants, Inc. as regulatory consultant. 1 device has linked clinical trial registered on ClinicalTrials.gov.
FDA 510(k) Regulatory Record - Zywie, Inc.
2 devices