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Cerner Corporation

United States·US-MF-000007215

Last updated September 17, 2026

Information

Country: United States
Address: 8779, Hillcrest Road, Kansas City, United States
Website: oracle.com
LinkedIn: —
Facebook: —
Email: [email protected]
Phone: —
PRRC Contact: Peter Gallo
EUDAMED SRN: US-MF-000007215
FDA FEI Number: 3013546957
DUNS Number: 042410688

Catalogue (47)

Device	Model / Reference	Registries	Class	Status
Cerner CareAware Event Management	CareAwareEventManagement5	FDA UDI	Class II	Active
Cerner CareAware iBus	CareAwareiBus5	FDA UDI	Class II	Active
FetaLink®	FetaLink2014	FDA UDI	Class II	Unknown
FetaLink+®	FetaLink+3	FDA UDI	Class II	Active
Oracle Health Blood Bank	PathNet Blood Bank Transfusion 2012	FDA UDI	Class II	Active
Cerner Motion Health	MotionHealth2016.22	FDA UDI	Class II	Unknown
Oracle Health Patient Observer	CPO-SP6	FDA UDI	Class I	Active
FetaLink+	FL+7	FDA UDI	Class II	Active
Oracle Health Patient Observer	CPO-SP4	FDA UDI	Class I	Active
Soarian Device Connect	CernerSDCv2.0	FDA UDI	Class II	Unknown
Oracle Health Blood Bank	PathNet Blood Bank Transfusion2015	FDA UDI	Class II	Active
Cerner CareAware iBus	CareAwareiBus6	FDA UDI	Class II	Active
NOVIUS Lab	27.2.2	FDA UDI	Class I	Unknown
Cerner FetaLink	FetaLink200	FDA UDI	Class II	Unknown
Cerner CareAware Event Management	CareAwareEventManagement6	FDA UDI	Class II	Active
FetaLink+	FetaLink+5	FDA UDI	Class II	Active
FetaLink®	FetaLink2013	FDA UDI	Class II	Unknown
Oracle Health Patient Observer	CPO-I415	FDA UDI	Class I	Active
FetaLink+®	FetaLink+4	FDA UDI	Class II	Active
FetaLink	FetaLink 200	FDA UDI	Class II	Active
Oracle Patient Observer	CPO-SP	FDA UDI	Class I	Active
Cerner SkyVue®	SkyVue2014	FDA UDI	Class II	Active
Oracle Health Patient Observer	CPO-SP7	FDA UDI	Class I	Active
FetaLink+	FetaLink+6	FDA UDI	Class II	Active
Cerner SkyVue®	SkyVue4	FDA UDI	Class II	Active
FetaLink+	FL+Android1	FDA UDI	Class II	Active
Melior	135648	EUDAMED	Class I	Active
Cerner Careaware Ibus	K093134	FDA 510(k)	Class II	Active
Proview Medical Image Display Module	K000770	FDA 510(k)	Class II	Active
Cerner Provision Workstation (version 2.5)	K091032	FDA 510(k)	Class II	Active
Cerner Fetalink+(version1.0)	K121758	FDA 510(k)	Class II	Active
Remote Viewing System Medical Image Display Module	K955000	FDA 510(k)	Class I	Active
Cerner CareAware Event Management	K151672	FDA 510(k)	Class II	Active
Cerner Provision Workstation	K070394	FDA 510(k)	Class II	Active
Cerner Fetalink (version 1.0)	K091251	FDA 510(k)	Class II	Active
Oracle Health Media Storage	10000496	EUDAMED	Class I	Active
Millennium Helix	100000137	EUDAMED	Class I	Active
i.s.h.med	10402294	EUDAMED	Class I	Active
Oracle Health Blood Bank	10000128	EUDAMEDFDA UDI	Class I	Active
Oracle Health Transfusion Adminstration and Oracle Health Bridge Specimen Collection	10000038 10000039	EUDAMEDFDA UDI	Class I	Active
Oracle Health Laboratory Sequence	10000216	EUDAMED	Class I	Active
Soarian Critical Care	1000024	EUDAMED	Class I	Active
Medication Clinical Decision Support	10000772	EUDAMED	Class I	Active
Oracle Health Maternity	10000151	EUDAMED	Class I	Active
Oracle Health General Laboratory	10000136	EUDAMED	Class I	Active
Obstetrix	1000197	EUDAMED	Class I	Active
Soarian Clinicals	07591964 07590248 07590230 07603512 07590255	EUDAMED	Class I	Active

Related Companies

Authorised Representatives

Oracle Nederland BV NL

Importers

Not available yet.

Notified Bodies

Not available yet.

Authorities

Not available yet.

FDA Recalls (2)

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
Jan 19, 2009	Z-1236-2009	—	terminated	Specimen labels printing incorrect patient demographics.
Aug 23, 2007	Z-1243-2007	—	terminated	Defects in the Auto Launch functionality make it possible for a mismatch of patient data.