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Natus Medical Incorporated

Last updated September 17, 2026

Information

Country: US
Address: 6225 Nancy Ridge Dr, SAN DIEGO, CA, 92121
Website: —
LinkedIn: —
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Email: —
Phone: —
PRRC Contact: —
EUDAMED SRN: —
FDA FEI Number: 2023988
DUNS Number: —

Catalogue (427)

Page 9 of 9

Device	Model / Reference	Registries	Class	Status
Natus®	NT8501381	FDA UDI	Class II	Active
Natus®	NT8507422	FDA UDI	Class II	Active
Natus Medical	013513	FDA UDI	Class II	Unknown
ALGO Newborn Hearing Screener	ALGO 5	FDA UDI	Class II	Active
Natus®	NT999414	FDA UDI	Class II	Active
Natus®	NT999304	FDA UDI	Class II	Active
Natus	025507	FDA UDI	Class II	Active
Natus®	HITH1	FDA UDI	Class II	Active
Natus®	NT98003S01	FDA UDI	Class II	Active
Natus®	NT9MZ211	FDA UDI	Class II	Active
Bio-logic	OAE Tree Tip Preemie	FDA UDI	Class II	Active
Bio-logic	OAE Tree Tip	FDA UDI	Class II	Active
Bio-logic	Insert Earphone Tip ER2 Adult	FDA UDI	Class II	Active
Bio-logic	Ear Clip Electode Pediatric	FDA UDI	Class II	Active
Natus Eds3 Lumbar Catheter Kit	NT821738C	FDA UDI	Class II	Active
AuDX Otoacoutic Emissions Measurement System wirh AuDX I/O Function	AuDX	FDA UDI	Class II	Active
Bio-logic	Insert Earphone Plastic Tip ER2	FDA UDI	Class II	Active
Olympic Warm-Lamps	Model 31	FDA UDI	Class II	Active
Natus Eds3 Drainage System	NT821731C	FDA UDI	Class II	Active
Bio-logic	OAE Jumbo Tip	FDA UDI	Class II	Active
Echo-Screen Iii Pro Hearing Screener With Barcode Scanner, Echo-Screen Iii Pro Hearing Screener Without Barcode Scanner,	K141446	FDA 510(k)	Class II	Active
neoBLUE compact LED Phototherapy System	K160745	FDA 510(k)	Class II	Active
Audx Otoacoustic Emissions Measurement System With Audx I/O Function	K111618	FDA 510(k)	Class II	Active
Neurolink Ip Model: Pk1117	K100683	FDA 510(k)	Class II	Active
A Baer With Abaer I/O Function	K112247	FDA 510(k)	Class II	Active
RetCam 3 ; RetCam Shuttle ; RetCam Portable	K182263	FDA 510(k)	Class II	Active
Olympic Cool-Cap System	P040025	FDA PMA	Class III	Active

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FDA Recalls (17)

Recalls reported by this firm to the FDA. Listed at company level — FDA recall records don't identify a specific catalogue device.

Date	Recall No.	Class	Status	Reason
Nov 28, 2023	Z-0634-2024	—	open, classified	Sterility assurance cannot be guaranteed for external drainage systems due to incomplete bioburden testing.
Nov 28, 2023	Z-0635-2024	—	open, classified	Sterility assurance cannot be guaranteed for external drainage systems due to incomplete bioburden testing.
Nov 18, 2022	Z-0735-2023	—	open, classified	Due to Cranial Access Kits containing recalled sterile surgical drapes. The sterile surgical drapes are being recalled due to the liner on the adhesive component is difficult to remove without damaging the product and may render the product unusable.
May 22, 2017	Z-2701-2017	—	terminated	Olympic Pasteurmatic 3000/3500 Systems are recalled because they do not fully meet todays regulatory requirements. Given the age of the products design, component and technology obsolescence, and the time involved in fully complying with the latest design and development standards, the firm decided to recall of the Olympic Pasteurmatic 3000/3500 System devices by means of disabling the devices.
Apr 3, 2017	Z-1924-2017	—	terminated	The second generation neoBLUE 2 lights with a black band, sold from 2003 to 2008, are recalled so it will eliminate the possibility that a neoBLUE system may have a replacement board installed which allows it to be used at a higher overall light intensity than the devices were originally cleared to deliver.
Oct 28, 2016	Z-0770-2017	—	terminated	neoBLUE blanket LED Phototherapy System distributed since release of the product in 2011 is recalled due to customer complaints regarding discoloration/ degradation of fiberoptic bundle at connection of pad and box.
Sep 16, 2016	Z-0769-2017	—	terminated	The firm sent the Technical Bulletin to consignees who received the reliability updated neoBLUE blanket LED Phototherapy Systems between March 2016 to August 2016. The reliability update to prevent the early failure of the fiberoptic pads experienced by some customers on older systems. These failures on previous systems involved discoloration and melting of the fiberoptic bundle at the connector that is inserted in the neoBLUE blanket light box.
Aug 25, 2016	Z-0056-2017	—	terminated	NatalCare LX incubators may have a defective base where the weld holding the wheel bushing to the tube is inadequate. There were several complaints of wheels bending out of alignment.
Apr 22, 2016	Z-1878-2016	—	terminated	The replacement HEPA Filters have been manufactured with sealant that may not be properly cured. Improperly cured sealant can emit a toxic gas when heated, and can drip down during use, contaminating the interior chamber of the Sterile Drier and its contents.
Apr 11, 2016	Z-2001-2016	—	terminated	The firm is adding the warning statement to the Instruction for Use for the neoBLUE LED Phototherapy System and provide a laminated Quick Guide to affix to each device.
Jan 8, 2016	Z-1363-2016	—	terminated	NatalCare LX Incubators were manufactured using a defective oval port hinge assembly with the result that the screws holding the port in place can become loose and possibly result in the port detaching from the incubator.
Aug 5, 2015	Z-0149-2016	—	terminated	The neoBLUE Instruction For Use (IFU) and Service Manuals for the neoBLUE 3 were revised to show the cleared intensity statement settings so the output intensity aligns precisely with the information listed in the cleared 510(k) submission.
Mar 16, 2015	Z-1412-2015	—	terminated	neoBLUE blanket LED Phototherapy System is recalled because Natus has received feedback from some customers about early failure of the neoBLUE blanket system fiberoptic pads. These failures involve discoloration and melting of the fiberoptic bundle at the connector that is inserted in the neoBLUE blanket light box.
Nov 19, 2014	Z-0847-2015	—	terminated	Replacement LED Board kit of Natus neoBLUE2 Phototherapy system distributed after February 16, 2012 is subject of a Field Safety Notification because the system will exhibit a higher light intensity output than the original device. While some customers may prefer using these lights at the higher intensity levels, some are concerned that patients may receive more intensity than desired.
May 21, 2012	Z-1843-2012	—	terminated	Olympic Cool-Cap Cooling Module's power supply failed during treatment. The power supply failure can happen without prior indication and results in the unavailability of the system to begin or continue cooling treatment.
May 9, 2012	Z-0447-2013	—	terminated	The Olympic Cool-Cap's Control Module has experienced a frozen screen during use. When this occurs, the on-screen information remains on display, but the system is no longer providing cooling treatment to the infants. The visible clock displayed at the upper right hand corner of the screen stops advancing.
Oct 1, 2009	Z-0420-2010	—	terminated	The clamp connecting the neoBLUE mini phototherapy light to the accessory pole stand can sustain stress fractures or break when excessive force is used when tightening the clamp. No injuries have been reported.