Medical Device Manufacturer · US , Johns Creek , GA

Zywie, Inc. - FDA 510(k) Cleared Devices

2 submissions · 2 cleared · Since 2015

2

Total

2

Cleared

0

Denied

FDA 510(k) Regulatory Record - Zywie, Inc. Cardiovascular ✕

2 devices

1-2 of 2

Cleared Jun 18, 2026

ZywieZ3 Sensor & Adhesive

Cardiovascular · 286d

Cleared Feb 20, 2015

ZywieAI Software Library

Cardiovascular · 151d