Natus Neurology Incorporated

FDA Regulatory Profile

Natus Neurology Incorporated appears in FDA public data with 1 recall, 5 510(k) clearances, 0 FDA inspections, and 0 compliance actions on record. Its most recent recall (Z-0946-2013, Class II) was initiated on February 27, 2013. Its most recent 510(k) clearance was granted on January 22, 2025.

Summary

Total Recalls
1
510(k) Clearances
5
Inspections
0
Compliance Actions
0

Recent Recalls

NumberClassProductDate
Z-0946-2013Class IINicolet EEG Wireless Amplifier 32/64 Channel. Catalog/Part Numbers : 515-015400 for the 32 channel aFebruary 27, 2013

Recent 510(k) Clearances

K-NumberDeviceDate
K243982Nicolet EDXJanuary 22, 2025
K243495Natus Ultrapro S100 (982A0594)December 12, 2024
K173366NicoletOneJuly 20, 2018
K172743Natus VikingQuestDecember 19, 2017
K130346SYNERGY FOCUS DESKTOP VERSION; SYNERGY FOCUS LAPTOP VERSIONMay 2, 2013