Natus Medical Incorporated
FDA Regulatory Profile
Natus Medical Incorporated appears in FDA public data with 18 recalls — including 1 Class I (most serious) —, 10 510(k) clearances, 18 FDA inspections, and 1 compliance action on record. Its most recent recall (Z-0635-2024, Class II) was initiated on November 28, 2023. Its most recent 510(k) clearance was granted on December 13, 2018.
Summary
- Total Recalls
- 18 (1 Class I)
- 510(k) Clearances
- 10
- Inspections
- 18
- Compliance Actions
- 1
Recent Recalls
| Number | Class | Product | Date |
|---|
| Z-0635-2024 | Class II | EDS 3 CSF External Drainage System, REF: NT821731C, STERILEEO, Rx only | November 28, 2023 |
| Z-0634-2024 | Class II | External Drainage System Collection Bag, REF: NT821732C, STERILEEO, Rx only | November 28, 2023 |
| Z-0735-2023 | Class II | The Natus Cranial Access Kit is designed to be a complete, single use and disposable accessory and i | November 18, 2022 |
| Z-2701-2017 | Class II | The Olympic Pasteurmatic 3000 and Olympic Pasteurmatic 3500 are intended for cleaning and high-level | May 22, 2017 |
| Z-1924-2017 | Class II | Second generation neoBLUE LED Phototherapy Light (neoBLUE 2) sold between 2003 and 2008. Catalog Par | April 3, 2017 |
| Z-0770-2017 | Class II | Natus neoBLUE blanket LED Phototherapy system, neonatal phototherapy. Used to provide treatment for | October 28, 2016 |
| Z-0769-2017 | Class II | Updated Natus neoBLUE blanket LED Phototherapy Systems. It provides phototherapy underneath the inf | September 16, 2016 |
| Z-0056-2017 | Class II | The Medix NatalCare LX Intensive Care Incubator. Neonatal incubator. Item numbers: DMNCLX1; KITNC- | August 25, 2016 |
| Z-1878-2016 | Class II | Replacement HEPA filter for Natus Sterile-Drier Model 43 and Model 44. Filter Catalogue Part Number | April 22, 2016 |
| Z-2001-2016 | Class II | Natus neoBLUE Phototherapy system, Catalogue Part Number: 010066. Top Assembly Part Numbers: 001103 | April 11, 2016 |
| Z-1363-2016 | Class II | Medix NatalCare ST-LX Intensive Care Incubator. Neonatal incubator. | January 8, 2016 |
| Z-0149-2016 | Class II | Natus neoBLUE 3 Phototherapy system or Neonatal Phototherapy, Catalogue Part Number: 010066; Top As | August 5, 2015 |
| Z-1412-2015 | Class II | Natus neoBLUE blanket LED Phototherapy system which includes the following items: 006224 neoBLUE | March 16, 2015 |
| Z-1068-2015 | Class II | EPWorks software used in the Xltek Protektor Stimulator Product Usage: Intraoperative diagnosis | January 2, 2015 |
| Z-1067-2015 | Class II | EPWorks software used in the Protektor 32 Product Usage: Uses electroencephalography (EEG), evok | January 2, 2015 |
| Z-0847-2015 | Class II | Replacement LED PCB Kit, part number 001840, of the Natus neoBLUE (aka neoBLUE 2) Phototherapy syste | November 19, 2014 |
| Z-1843-2012 | Class II | Olympic Cool-Cap System is intended to provide treatment for neonatal hypoxic-ischemic encephalopat | May 21, 2012 |
| Z-0447-2013 | Class I | The product has the Catalogue/Part number 60010. Olympic Cool-Cap System is a selective head cool | May 9, 2012 |
Recent 510(k) Clearances
| K-Number | Device | Date |
|---|
| K182178 | neoBLUE blanket LED Phototherapy System | December 13, 2018 |
| K182263 | RetCam 3 ; RetCam Shuttle ; RetCam Portable | September 7, 2018 |
| K160745 | neoBLUE compact LED Phototherapy System | December 12, 2016 |
| K160305 | neoBLUE® LED Phototherapy System | May 27, 2016 |
| K143440 | Natus Quantum | April 20, 2015 |
| K141446 | ECHO-SCREEN III PRO HEARING SCREENER WITH BARCODE SCANNER, ECHO-SCREEN III PRO HEARING SCREENER WITH | August 22, 2014 |
| K112247 | A BAER WITH ABAER I/O FUNCTION | April 2, 2012 |
| K111618 | AUDX OTOACOUSTIC EMISSIONS MEASUREMENT SYSTEM WITH AUDX I/O FUNCTION | December 28, 2011 |
| K103589 | NEOBLUE BLANKET LED PHOTOTHERAPY SYSTEM | May 13, 2011 |
| K100683 | NEUROLINK IP MODEL: PK1117 | April 9, 2010 |