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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: —
Facebook: —
Email: —
Phone: —
PRRC Contact: —
EUDAMED SRN: —
FDA FEI Number: 2023988
DUNS Number: —

Catalogue (427)

Page 4 of 9

Device	Model / Reference	Registries	Class	Status
Natus®	NT96001S01	FDA UDI	Class II	Active
Natus®	NT8501222	FDA UDI	Class II	Active
Bio-logic	Insert Earphone Tip Adapter Infant	FDA UDI	Class II	Active
Bio-logic	OAE Foam Tip Pediatric	FDA UDI	Class II	Active
Natus®	NT8501125	FDA UDI	Class II	Active
Natus®	NT8501215	FDA UDI	Class II	Active
Natus®	NTCFRL	FDA UDI	Class II	Active
Natus	HITHNDX	FDA UDI	Class II	Active
Natus®	NT901165	FDA UDI	Class II	Active
Natus	025517	FDA UDI	Class II	Active
Natus®	NT999110	FDA UDI	Class II	Active
Bio-Logic AudX	580-AXBBOX-002	FDA UDI	Class II	Active
Natus	HITHRZRX	FDA UDI	Class II	Active
Natus	Gold Ear Clip Electrode Pediatric	FDA UDI	Class II	Active
Natus®	NT955141	FDA UDI	Class II	Active
Natus®	NT8500132	FDA UDI	Class II	Active
Natus®	NT9MZ203	FDA UDI	Class II	Active
Natus®	NT9MZ110N	FDA UDI	Class II	Active
Natus®	NT999015	FDA UDI	Class II	Active
Natus®	NT11811	FDA UDI	Class II	Active
Natus®	NT8509311	FDA UDI	Class II	Active
Natus®	NT8501382	FDA UDI	Class II	Active
Natus®	NT901182	FDA UDI	Class II	Active
Natus®	NT908162	FDA UDI	Class II	Active
Echo-Screen III Pro	EchoScreen III Refurbished, ABR with barcode	FDA UDI	Class II	Active
ALGO Hearing Screening Supplies	ALGO Jelly Tab	FDA UDI	Class II	Active
neoBLUE	blanket Mattress Large	FDA UDI	Class II	Active
Bio-logic	Halo Ear Muffin Adapter Tube	FDA UDI	Class II	Active
Natus	Infant Ear Tip 4 mm	FDA UDI	Class II	Active
Natus®	NT8507421	FDA UDI	Class II	Active
Bio-Logic AudX	580-AXPBOX-039	FDA UDI	Class II	Active
Natus	Ear Probe Tip Blue	FDA UDI	Class II	Active
Natus®	NT8501359	FDA UDI	Class II	Active
Natus®	NT9MZ101	FDA UDI	Class II	Active
Natus®	NT11813	FDA UDI	Class II	Active
Natus®	NT990010	FDA UDI	Class II	Active
Natus®	NT990001	FDA UDI	Class II	Active
Bio-logic	OAE 6mm Tip	FDA UDI	Class II	Active
Natus®	NT903345A	FDA UDI	Class II	Active
Olympic CFM	Electrode Hydrogel	FDA UDI	Class II	Active
Natus Medical	013502	FDA UDI	Class II	Unknown
Natus®	NT8500105	FDA UDI	Class II	Active
Natus®	NT8500200	FDA UDI	Class II	Active
Natus®	NT999410	FDA UDI	Class II	Active
Natus®	NT8501356	FDA UDI	Class II	Active
Natus®	NTCFRM	FDA UDI	Class II	Active
Natus®	NT907162	FDA UDI	Class II	Active
Scout Sport Otoacoustic Emissions Measurement System	Scout Sport	FDA UDI	Class II	Active
Natus Medical	013504	FDA UDI	Class II	Unknown
Natus	Child/Adult Ear Tip 10 mm	FDA UDI	Class II	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.