Company
Natus Neurology DBA Excel Tech., Ltd. (XLTEK)
FDA 510(k) clearances and medical device recalls filed under this name. Name variants (Inc, Corp, punctuation) are merged.
0510(k) clearances (0 in 12 months)
7recalls (0 in 12 months)
5recalls that name a 510(k)
Product codes
Latest 510(k) clearances
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| No clearances in this window. | |||
Latest recalls
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jul 18, 2025 | Natus Neurology DBA Excel Tech., Ltd. (XLTEK) Natus Brain Monitor Breakout Box, Part Number 021911; full-montage standard electroencephalograph Open, Classified |
GWQ | K180290 |
| Jun 9, 2025 | Natus Neurology DBA Excel Tech., Ltd. (XLTEK) Brand Name: OBM00002 OBM DAB (Digital Acquisition Box)
Product Name: OBM00002 OBM DAB (Digital Acquisition Box)
Model/Catalog Number: OBM00002 OBM DAB (Digital Acquisition Box)
Software Version: N/A
P Open, Classified |
OMA | K123079 |
| Dec 2, 2021 | Natus Neurology DBA Excel Tech., Ltd. (XLTEK) IPELA FHD PTZ TILE KITS with Axis cameras used in combination with Natus Neuroworks/Sleepworks software Terminated |
OMB | K090019 K090277 |
| Apr 1, 2020 | Natus Neurology DBA Excel Tech., Ltd. (XLTEK) natus newborn care Olympic Brainz Monitor, REF OBM00002. electroencephalograph Terminated |
OMA | K123079 |
| May 18, 2018 | Natus Neurology DBA Excel Tech., Ltd. (XLTEK) Natus Neurology ErgoJust Carts labeled as the following: ICU Cart Export For PTZ Video Ext, IP PTZ HD ErgoJust Video Extension, EuroJust ICU Cart Export For PTZ Video Ext.
Video cart used for mobile Terminated |
ODI | None listed |
| May 15, 2018 | Natus Neurology DBA Excel Tech., Ltd. (XLTEK) XLTEK EMU40EX EEG Headbox Terminated |
GWQ | None listed |
| Nov 11, 2015 | Natus Neurology DBA Excel Tech., Ltd. (XLTEK) Natus Quantum System with NeuroWorks Software. Catalog /Part Numbers: 013926.
The Natus Quantum Amplifier is intended to be used as an electroencephalograph: to acquire, display, store and archive el Terminated |
GWQ | K143440 |