Zyno Medical, LLC
Zyno Medical, LLC holds FDA 510(k) medical device clearances, first cleared 2007, most recent 2016, with 16 FDA device recalls on record.
Top product codes for Zyno Medical, LLC
FDA recalls by Zyno Medical, LLC
10 most recent of 16- Z-1867-2025 — Z-800W Infusion System. Intended to provide intravenous infusion of parenteral fluids, blood, and blood products to a patient.
- Z-1868-2025 — Z-800WF Infusion System. Intended to provide intravenous infusion of parenteral fluids, blood, and blood products to a patient.
- Z-1865-2025 — Z-800 Infusion System. Intended to provide intravenous infusion of parenteral fluids, blood, and blood products to a patient.
- Z-1866-2025 — Z-800F Infusion System. Intended to provide intravenous infusion of parenteral fluids, blood, and blood products to a patient.
- Z-0506-2025 — Z-800 Infusion System. Model/Catalog Number: Z-800, Z-800F, Z-800W, Z-800WF. The Z-800 Infusion system is intended to provide intravenous infusion of parenteral fluids, blood, and blood products to a patient under the direction or supervision of a physician or other certified healthcare professional.
- Z-0523-2025 — Brand Name: Z-800 Infusion System Product Name: Z-800WF Model/Catalog Number: Z-800WF. The Z-800 Infusion system is intended to provide intravenous infusion of parenteral fluids, blood, and blood products to a patient under the direction or supervision physician or other certified healthcare professional.
- 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
- Z-2263-2024 — Zyno Medical Z800, Z800F, Z800W, and Z800WF Infusion Pumps
- Z-1183-2024 — Zyno Medical Z800 Large Volume Infusion Pumps -Intended to provide intravenous infusion of parenteral fluids, blood and blood products to a patient under the direction or supervision of physician or other certified health care professional Model: Z-800WF
- Z-2058-2019 — Zyno Medical Administration Set -105"ADMIN SET 20DP, W/2 Y SITE, CVCLMPS- For Use with Zyno Medical Infusion pumps or Gravity Feed Product Code:B2-70072
Recalls are matched by FDA's recalling-firm name — openFDA's enforcement dataset doesn't reference 510(k) numbers, so a recall here may cover devices beyond this company's 510(k) clearances.
Recent clearances by Zyno Medical, LLC
- K153193 — Halo II Ambulatory Infusion System (also with trade names Nimbus II Ambulatory Infusion System, EVAA Ambulatory Infusion System)
- K140783 — HALO AMBULATORY INFUSION SYSTEM
- K132841 — ZYNO MEDICAL ADMINISTRATION SET
- K130690 — Z-800 INFUSION SYSTEM
- K120685 — ZYNO MEDICAL ADMINISTRATION SET
- K100705 — ZYNO Z-800 INFUSION SYSTEM MODEL Z-800
- K071545 — Z-800 VOLUMETRIC INFUSION PUMP
Data sourced from openFDA. This site is unofficial and independent of the FDA.