Company ยท US
Natus Neurology Inc
FDA 510(k) clearances and medical device recalls filed under this name, 2013 to 2025. Name variants (Inc, Corp, punctuation) are merged.
5510(k) clearances (0 in 12 months)
9recalls (0 in 12 months)
9recalls that name a 510(k)
Product codes
| Code | Device | Records |
|---|---|---|
| JAF | Monitor, Ultrasonic, Nonfetal | 4 |
| GWF | Stimulator, Electrical, Evoked Response | 3 |
| GYB | Media, Electroconductive | 2 |
| GWL | Amplifier, Physiological Signal | 1 |
| GWQ | Full-Montage Standard Electroencephalograph | 1 |
| IKN | Electromyograph, Diagnostic | 1 |
| OLV | Standard Polysomnograph With Electroencephalograph | 1 |
| OLZ | Automatic Event Detection Software For Polysomnograph With Electroencephalograph | 1 |
Latest 510(k) clearances
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Jan 22, 2025 | K243982 | Nicolet EDX Natus Neurology Incorporated | GWF |
| Dec 12, 2024 | K243495 | Natus Ultrapro S100 (982A0594) Natus Neurology Incorporated | GWF |
| Jul 20, 2018 | K173366 | NicoletOne Natus Neurology Incorporated | OLZ |
| Dec 19, 2017 | K172743 | Natus VikingQuest Natus Neurology Incorporated | IKN |
| May 2, 2013 | K130346 | SYNERGY FOCUS DESKTOP VERSION; SYNERGY FOCUS LAPTOP VERSION Natus Neurology Incorporated | GWF |
Latest recalls
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Mar 19, 2024 | Natus Neurology Inc natus neurology, Sleep Supplies Start Kit with Single Use Supplies for Embla EX Series Amplifiers, REF 024252 Open, Classified |
GYB | K852956 |
| Mar 19, 2024 | Natus Neurology Inc TENSIVE Conductive Adhesive Gel, REF 016-401600 Open, Classified |
GYB | K852956 |
| Feb 1, 2018 | Natus Neurology Inc Nicolet Ambulatory EEG Terminated |
OLV | K021185 |
| Jun 9, 2017 | Natus Neurology Inc Nicolet Elite 5 MHz Vascular Probe, Model #: X1L004, Catalog Code: N500.
Intended for non-invasive support, i.e. early detection of fetal life, monitor blood flow before and after surgery, etc. Terminated |
JAF | K982635 |
| Jun 9, 2017 | Natus Neurology Inc Nicolet Elite 3 MHz OB Probe, Model #: X1L001, Catalog Code: N300.
Intended for non-invasive support, i.e. early detection of fetal life, monitor blood flow before and after surgery, etc. Terminated |
JAF | K982635 |
| Jun 9, 2017 | Natus Neurology Inc Nicolet Elite 2 MHz OB Water Proof Probe, Model #: X1L008, Catalog Code: NW20.
Intended for non-invasive support, i.e. early detection of fetal life, monitor blood flow before and after surgery, et Terminated |
JAF | K982635 |
| Jun 9, 2017 | Natus Neurology Inc Nicolet Elite 2 MHz OB Probe, Non-Fetal Monitor, Model #: X1L007, Catalog Code: N200.
Intended for non-invasive support, i.e. early detection of fetal life, monitor blood flow before and after surg Terminated |
JAF | K982635 |
| Oct 13, 2015 | Natus Neurology Inc NicoletOne Software v5.94, Catalog/Part Number: 482-649600.
The NicoletOne data acquisition and review system, either with or without synchronous digital video. The system is intended for medical purp Terminated |
GWQ | K964280 |
| Mar 13, 2013 | Natus Neurology Incorporated Nicolet EEG Wireless Amplifier 32/64 Channel. Catalog/Part Numbers : 515-015400 for the 32 channel amplifier and 515-015500 for the 64 channel amplifier.
Product Usage:
The Nicolet Wireless EEG Ampli Terminated |
GWL | K103140 |