FDA Device Entity Profile: Zyno Medical LLC.

Known Identifiers & Locations

FEI Numbers 3006575795

Owner Operator Numbers 10023155

Locations Covered Natick, MA, US

Registered Establishments (1)

Registration #	Establishment Name	Location	Establishment Type(s)	Action
3006575795	Zyno Medical LLC.	Natick, MA, US	Develop Specifications But Do Not Manufacture At This Facility,Manufacture Medical Device	View Details

510(k) Premarket Notifications (0)

No 510(k) notifications found for this entity.

FDA Recall History (1)

Recall #	Product Description	Initiation Date	Status	Action
Z-0005-2025	Z-800 Infusion System, Model Numbers Z-800, Z-800F, Z-800W, Z-800WF; Software Version: Z-800 6.1.01 and 6-1.07z; Z-800F 4.1.02 and 4.1.08z; Z-800W 3.1.32 and 3.1.64z, Z-800WF 3.1.32 and 3.1.64z Reason: There is a defect in the air-in-line software algorithm.	2024-09-13	Open, Classified	View Details

Profile Disclaimer

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