Data / Medical devices / United States / Cerner Corporation
Cerner Corporation: FDA-registered device maker in Kansas City, MO, United States, 4 510(k) clearances
Cerner Corporation is registered with the FDA (registration 3013546957) in Kansas City, MO, United States. It lists 6 device types. The FDA files 4 510(k) clearances under its listings, the newest dated December 21, 2015. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3013546957
- Address
- 8779 Hillcrest Rd, Kansas City, MO, United States, 64138
- Owner or operator
- Cerner Corporation (9011113)
- Roles
- Complaint file establishment, Manufacturer
- First device listed
- November 1, 2006
- Registered through
- 2026
- Brand names listed
- Cerner CareAware IBus, Cerner FetaLink+, FetaLink, Image Viewer, Oracle Health Blood Bank, Oracle Health Event Management, Oracle Health Patient Observer, Oracle Health Transfusion Administration and Oracle Health Bridge Specimen Collection
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Blood Establishment Computer Software And Accessories | MMH | 2 | Complaint file establishment, Manufacturer | accessdata.fda.gov |
| Monitor, Bed Patient | KMI | 1 | Complaint file establishment, Manufacturer | accessdata.fda.gov |
| System, Digital Image Communications, Radiological | LMD | 1 | Complaint file establishment, Manufacturer | accessdata.fda.gov |
| System, Monitoring, Perinatal | HGM | 2 | Complaint file establishment, Manufacturer | accessdata.fda.gov |
| System, Network And Communication, Physiological Monitors | MSX | 2 | Complaint file establishment, Manufacturer | accessdata.fda.gov |
| Transmitters And Receivers, Physiological Signal, Radiofrequency | DRG | 2 | Complaint file establishment, Manufacturer | accessdata.fda.gov |
510(k) clearances
The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.
| Decided | 510(k) number | Device | Product code | Decision | Applicant | Source |
|---|---|---|---|---|---|---|
| December 21, 2015 | K151672 | Cerner CareAware Event Management | MSX | Substantially Equivalent | Cerner Corporation | accessdata.fda.gov |
| October 9, 2012 | K121758 | CERNER FETALINK+(VERSION1.0) | HGM | Substantially Equivalent | Cerner Corp. | accessdata.fda.gov |
| November 27, 2009 | K093134 | CERNER CAREAWARE IBUS | DRG | Substantially Equivalent | Cerner Corp. | accessdata.fda.gov |
| August 25, 2009 | K091251 | CERNER FETALINK (VERSION 1.0) | HGM | Substantially Equivalent | Cerner Corp. | accessdata.fda.gov |
Compare with other makers
- All makers of Transmitters And Receivers, Physiological Signal, Radiofrequency
- All makers of Blood Establishment Computer Software And Accessories
- All makers of System, Network And Communication, Physiological Monitors
- All makers of System, Digital Image Communications, Radiological
- All makers of System, Monitoring, Perinatal
- All makers of Monitor, Bed Patient
Updated December 21, 2015. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.