Natus Neurology DBA Excel Tech., Ltd. (XLTEK)

FDA Regulatory Profile

Natus Neurology DBA Excel Tech., Ltd. (XLTEK) appears in FDA public data with 7 recalls, 0 510(k) clearances, 0 FDA inspections, and 0 compliance actions on record. Its most recent recall (Z-2138-2025, Class II) was initiated on June 18, 2025.

Summary

Total Recalls
7
510(k) Clearances
0
Inspections
0
Compliance Actions
0

Recent Recalls

NumberClassProductDate
Z-2138-2025Class IINatus Brain Monitor Breakout Box, Part Number 021911; full-montage standard electroencephalographJune 18, 2025
Z-1925-2025Class IIBrand Name: OBM00002 OBM DAB (Digital Acquisition Box) Product Name: OBM00002 OBM DAB (Digital AcquMay 7, 2025
Z-0661-2022Class IIIPELA FHD PTZ TILE KITS with Axis cameras used in combination with Natus Neuroworks/Sleepworks softwDecember 2, 2021
Z-1630-2020Class IInatus newborn care Olympic Brainz Monitor, REF OBM00002. electroencephalographMarch 5, 2020
Z-2737-2018Class IINatus Neurology ErgoJust Carts labeled as the following: ICU Cart Export For PTZ Video Ext, IP PTZ HMay 18, 2018
Z-2570-2018Class IIXLTEK EMU40EX EEG HeadboxMay 15, 2018
Z-0581-2016Class IINatus Quantum System with NeuroWorks Software. Catalog /Part Numbers: 013926. The Natus Quantum ANovember 11, 2015