Neurologica Corporation
Neurologica Corporation holds FDA 510(k) medical device clearances, first cleared 2005, most recent 2025, with 13 FDA device recalls on record.
Top product codes for Neurologica Corporation
FDA recalls by Neurologica Corporation
10 most recent of 13- Z-0480-2026 — GM85 Digital Mobile X-ray imaging System; Model Number: GM85;
- Z-2715-2024 — GM60A. Digital Diagnostic Mobile X-Ray System.
- Z-1056-2024 — Samsung Digital Diagnostic Mobile X-ray System, Model GM85.
- Z-2068-2023 — OmniTom/OmniTom Elite- X-ray computed tomography applications for anatomy that can be imaged in the 40 cm aperture, primarily head and neck Model Number: NL5000
- Z-1414-2023 — Samsung GM85 Digital X-ray Imaging System-A Digital Diagnostic Mobile X-ray System
- Z-2772-2020 — OmniTom Computed tomography x-ray system, Model NL5000, all NL5000 systems with software version before 05.01.01 - Product Usage: is intended to be used for x-ray computed tomography applications for anatomy that can be imaged in the 40 cm aperture, primarily head and neck.
- Z-2276-2019 — WS80A Diagnostic Ultrasound System Version 1.00.16, 3.00.17, 3.00.18, 3.00.19, 3.01.00, 3.01.01, 3.01.02, 3.01.03, 3.01.04, 3.01.05, 3.01.06, 3.01.07, 3.01.08, 3.01.09, 4.00.08, 4.00.09, 4.00.10, 4.00.11, 4.01.00, 4.01.01, 4.01.02, 4.01.03, 4.01.04, 4.01.05, 4.01.06, 4.01.07, 4.01.08, 4.01.09.
- Z-2275-2019 — HS70A Diagnostic Ultrasound System Version 2.01.00, 2.01.01, 2.01.02, 2.01.03, 2.01.04, 2.01.05, 2.01.06, 1.00.06, 1.00.07, 1.00.08, 1.00.09, 1.00.10, 1.00.11, 1.00.12
- Z-1691-2019 — Samsung GM85 Mobile Digital X-ray Imaging System Product Usage: The GM85 Digital X-ray imaging System is intended for use in generating radiographic images of human anatomy by a qualified/trained doctor or technician. This device is not intended for mammographic applications
- Z-1391-2018 — Solid state x-ray imager (flat panel/digital imager) Solid state x-ray imager (flat panel/digital imager) Medical
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 Neurologica Corporation
Data sourced from openFDA. This site is unofficial and independent of the FDA.