Natus Manufacturing Limited

FDA Regulatory Profile

Summary

Total Recalls
2
510(k) Clearances
4
Inspections
2
Compliance Actions
0

Recent Recalls

NumberClassProductDate
Z-1143-2021Class IIRef: NT821731C, Natus EDS 3 CSF External Drainage System - Product Usage: indicated for draining ceJanuary 12, 2021
Z-0951-2017Class IINatus Warmette Blanket Cabinet and Warmette Dual Cabinet The Natus Warmette Blanket Cabinet is desiOctober 15, 2016

Recent 510(k) Clearances

K-NumberDeviceDate
K242346Grass® MR Conditional/CT Cup ElectrodesAugust 29, 2024
K173815Allergan Botox Needle ElectrodeJune 29, 2018
K161430Myoject Luer Lock Needle ElectrodeMarch 2, 2017
K143433Dantec DCN Disposable Concentric Needle Electrodes-25mm, Dantec DCN Disposable Concentric Needle EleAugust 28, 2015