Natus Medical Incorporated

FDA Regulatory Profile

Summary

Total Recalls
18 (1 Class I)
510(k) Clearances
10
Inspections
15
Compliance Actions
1

Recent Recalls

NumberClassProductDate
Z-0635-2024Class IIEDS 3 CSF External Drainage System, REF: NT821731C, STERILEEO, Rx onlyNovember 28, 2023
Z-0634-2024Class IIExternal Drainage System Collection Bag, REF: NT821732C, STERILEEO, Rx onlyNovember 28, 2023
Z-0735-2023Class IIThe Natus Cranial Access Kit is designed to be a complete, single use and disposable accessory and iNovember 18, 2022
Z-2701-2017Class IIThe Olympic Pasteurmatic 3000 and Olympic Pasteurmatic 3500 are intended for cleaning and high-levelMay 22, 2017
Z-1924-2017Class IISecond generation neoBLUE LED Phototherapy Light (neoBLUE 2) sold between 2003 and 2008. Catalog ParApril 3, 2017
Z-0770-2017Class IINatus neoBLUE blanket LED Phototherapy system, neonatal phototherapy. Used to provide treatment for October 28, 2016
Z-0769-2017Class IIUpdated Natus neoBLUE blanket LED Phototherapy Systems. It provides phototherapy underneath the infSeptember 16, 2016
Z-0056-2017Class IIThe Medix NatalCare LX Intensive Care Incubator. Neonatal incubator. Item numbers: DMNCLX1; KITNC-August 25, 2016
Z-1878-2016Class IIReplacement HEPA filter for Natus Sterile-Drier Model 43 and Model 44. Filter Catalogue Part NumberApril 22, 2016
Z-2001-2016Class IINatus neoBLUE Phototherapy system, Catalogue Part Number: 010066. Top Assembly Part Numbers: 001103April 11, 2016
Z-1363-2016Class IIMedix NatalCare ST-LX Intensive Care Incubator. Neonatal incubator.January 8, 2016
Z-0149-2016Class IINatus neoBLUE 3 Phototherapy system or Neonatal Phototherapy, Catalogue Part Number: 010066; Top AsAugust 5, 2015
Z-1412-2015Class IINatus neoBLUE blanket LED Phototherapy system which includes the following items: 006224 neoBLUE March 16, 2015
Z-1068-2015Class IIEPWorks software used in the Xltek Protektor Stimulator Product Usage: Intraoperative diagnosis January 2, 2015
Z-1067-2015Class IIEPWorks software used in the Protektor 32 Product Usage: Uses electroencephalography (EEG), evokJanuary 2, 2015
Z-0847-2015Class IIReplacement LED PCB Kit, part number 001840, of the Natus neoBLUE (aka neoBLUE 2) Phototherapy systeNovember 19, 2014
Z-1843-2012Class IIOlympic Cool-Cap System is intended to provide treatment for neonatal hypoxic-ischemic encephalopatMay 21, 2012
Z-0447-2013Class IThe product has the Catalogue/Part number 60010. Olympic Cool-Cap System is a selective head coolMay 9, 2012

Recent 510(k) Clearances

K-NumberDeviceDate
K182178neoBLUE blanket LED Phototherapy SystemDecember 13, 2018
K182263RetCam 3 ; RetCam Shuttle ; RetCam PortableSeptember 7, 2018
K160745neoBLUE compact LED Phototherapy SystemDecember 12, 2016
K160305neoBLUE® LED Phototherapy SystemMay 27, 2016
K143440Natus QuantumApril 20, 2015
K141446ECHO-SCREEN III PRO HEARING SCREENER WITH BARCODE SCANNER, ECHO-SCREEN III PRO HEARING SCREENER WITHAugust 22, 2014
K112247A BAER WITH ABAER I/O FUNCTIONApril 2, 2012
K111618AUDX OTOACOUSTIC EMISSIONS MEASUREMENT SYSTEM WITH AUDX I/O FUNCTIONDecember 28, 2011
K103589NEOBLUE BLANKET LED PHOTOTHERAPY SYSTEMMay 13, 2011
K100683NEUROLINK IP MODEL: PK1117April 9, 2010