Natus Neurology Inc

FDA Regulatory Profile

Summary

Total Recalls
8
510(k) Clearances
0
Inspections
2
Compliance Actions
0

Recent Recalls

NumberClassProductDate
Z-1305-2024Class IITENSIVE Conductive Adhesive Gel, REF 016-401600February 7, 2024
Z-1306-2024Class IInatus neurology, Sleep Supplies Start Kit with Single Use Supplies for Embla EX Series Amplifiers, RFebruary 7, 2024
Z-2568-2018Class IINicolet¿ Ambulatory EEGFebruary 1, 2018
Z-2726-2017Class IINicolet¿ Elite¿ 2 MHz OB Probe, Non-Fetal Monitor, Model #: X1L007, Catalog Code: N200. Intended June 9, 2017
Z-2729-2017Class IINicolet¿ Elite¿ 5 MHz Vascular Probe, Model #: X1L004, Catalog Code: N500. Intended for non-invasJune 9, 2017
Z-2728-2017Class IINicolet¿ Elite¿ 3 MHz OB Probe, Model #: X1L001, Catalog Code: N300. Intended for non-invasive suJune 9, 2017
Z-2727-2017Class IINicolet¿ Elite¿ 2 MHz OB Water Proof Probe, Model #: X1L008, Catalog Code: NW20. Intended for nonJune 9, 2017
Z-0117-2016Class IINicoletOne Software v5.94, Catalog/Part Number: 482-649600. The NicoletOne data acquisition and revSeptember 11, 2015