Cerner Corp

FDA Filings

This page includes the latest FDA filings for Cerner Corp. Currently, you will find the latest 100 filings for Premarket Notifications, Premarket Applications, De Novo Applications, and GUDID registrations.

Cerner Corp holds import registrations or U.S. agent authorizations in conjunction with the following organizations:

FDA Registration(s)
Registration Number3008058132
FEI Number3008058132
NameSHELLEY S LOOBY
Owner & OperatorCERNER CORP.
Contact Address2800 ROCKCREEK PKWY. --
Kansas City MO 64117 US
Official Correspondent
  • SHELLEY S LOOBY
  • x-816-2011368-x
US Agent
Registration Status1
Initial ImporterN
Registration Expiration2020-04-25
Registration Address2800 ROCKCREEK PKWY
Kansas City, MO 64117 US
Establishment TypeManufacture Medical Device



Registration Number3013546957
FEI Number3013546957
NameCerner Corporation
Owner & OperatorCERNER CORP.
Contact Address2800 ROCKCREEK PKWY. --
Kansas City MO 64117 US
Official Correspondent
  • SHELLEY S LOOBY
  • x-816-2011368-x
Registration Status1
Initial ImporterY
Registration Expiration2020-04-25
Registration Address8779 Hillcrest Rd
Kansas City, MO 64138 US
Establishment TypeManufacture Medical Device



Registration Number1931259
FEI Number1931259
NameCERNER CORP.
Owner & OperatorCERNER CORP.
Contact Address2800 ROCKCREEK PKWY. --
Kansas City MO 64117 US
Official Correspondent
  • SHELLEY S LOOBY
  • x-816-2011368-x
Registration Status1
Initial ImporterY
Registration Expiration2020-04-25
Registration Address2800 ROCKCREEK PKWY.
KANSAS CITY, MO 64117 US
Establishment TypeComplaint File Establishment per 21 CFR 820.198



FDA Filings

Device
Company
DeviceDate
Cerner Corporation
FetaLink+ 2024-06-03
CERNER CORPORATION
Cerner Patient Observer CFG_PATOBSRVR2020-12-22
CERNER CORPORATION
Cerner Patient Observer CFG_PATOBSRVR2020-02-10
CERNER CORPORATION
Cerner Patient Observer CFG_PATOBSRVR2019-10-08
CERNER CORPORATION
Cerner Patient Observer CFG_PATOBSRVR2019-10-08
CERNER CORPORATION
Cerner Patient Observer CFG_PATOBSRVR2019-10-08
CERNER CORPORATION
Cerner CareAware Event Management 2019-07-12
CERNER CORPORATION
Cerner CareAware Event Management 2019-07-12
CERNER CORPORATION
Cerner FetaLink 2019-05-09
CERNER CORPORATION
FetaLink+ 2019-05-09
CERNER CORPORATION
Cerner CareAware iBus 2018-11-08
CERNER CORPORATION
Soarian Device Connect 2018-11-08
CERNER CORPORATION
Cerner CareAware iBus 2018-11-08
CERNER CORPORATION
PathNet® Blood Bank Transfusion 2018-07-06
CERNER CORPORATION
FetaLink+ 2018-07-06
CERNER CORPORATION
FetaLink+® 2018-07-06
CERNER CORPORATION
Cerner Bridge Medical Transfusion Administration and Specimen Collections 2018-07-06
CERNER CORPORATION
PathNet® Blood Bank Transfusion 2018-07-06
CERNER CORPORATION
FetaLink® 2018-07-06
CERNER CORPORATION
PathNet® Blood Bank Transfusion 2018-07-06
CERNER CORPORATION
FetaLink+® 2018-07-06
CERNER CORPORATION
FetaLink® 2018-07-06
CERNER CORPORATION
Cerner Motion Health 2018-06-26
CERNER CORPORATION
NOVIUS Lab 2018-03-29
CERNER CORPORATION
Cerner SkyVue® 2018-03-29
CERNER CORPORATION
Cerner SkyVue® 2018-03-29
CERNER CORP.
Cerner Motion Health2017-07-26
Cerner Corporation [CERNER CORP.]
Cerner CareAware Event Management2016-02-24
CERNER CORP.
Cerner CareAware Event Management2016-02-24
Cerner Corporation [CERNER CORP.]
Cerner Patient Observer2016-01-12
CERNER CORP.
Cerner Patient Observer2016-01-12
CERNER CORPORATION
Cerner CareAware Event Management2015-12-21
CERNER CORP.
Cerner Automated Aliquotter AA2013-05-01
Cerner Corporation [CERNER CORP.]
Cerner FetaLink+2012-11-05
CERNER CORP.
Cerner FetaLink+2012-11-05
CERNER CORP.
CERNER FETALINK+(VERSION1.0)2012-10-09
Cerner Corporation [CERNER CORP.]
Reference Lab Network2011-04-13
Cerner Corporation [CERNER CORP.]
HL7 2.x ORU R03 Interface (Quest)2011-04-13
Cerner Corporation [CERNER CORP.]
FSI Clinical Results Interface Outbound2011-04-13
Cerner Corporation [CERNER CORP.]
FSI Clinical Results Interface Inbound2011-04-13
Cerner Corporation [CERNER CORP.]
CareAware Ventilators Device Driver2011-04-13
Cerner Corporation [CERNER CORP.]
CareAware Urinalysis Device Driver2011-04-13
Cerner Corporation [CERNER CORP.]
CareAware Smart Pumps Device Driver2011-04-13
Cerner Corporation [CERNER CORP.]
CareAware Respiratory Device Driver2011-04-13
Cerner Corporation [CERNER CORP.]
CareAware Pulse Oximeters Device Driver2011-04-13
Cerner Corporation [CERNER CORP.]
CareAware Point of Care Device Driver2011-04-13
Cerner Corporation [CERNER CORP.]
CareAware Personal Health Device Driver2011-04-13
Cerner Corporation [CERNER CORP.]
CareAware Opthalmology Device Driver2011-04-13
Cerner Corporation [CERNER CORP.]
CareAware Monitors Device Driver2011-04-13
Cerner Corporation [CERNER CORP.]
CareAware Microbiology Device Driver2011-04-13
Cerner Corporation [CERNER CORP.]
CareAware Medication Dispensing Device Driver2011-04-13
Cerner Corporation [CERNER CORP.]
CareAware Laboratory Automation Device Driver2011-04-13
Cerner Corporation [CERNER CORP.]
CareAware Imaging Device Driver2011-04-13
Cerner Corporation [CERNER CORP.]
CareAware Hematology Device Driver2011-04-13
Cerner Corporation [CERNER CORP.]
CareAware Fetal Monitoring Device Driver2011-04-13
Cerner Corporation [CERNER CORP.]
CareAware Dialysis Device Driver2011-04-13
Cerner Corporation [CERNER CORP.]
CareAware Coagulation Device Driver2011-04-13
Cerner Corporation [CERNER CORP.]
CareAware Chemistry Device Driver2011-04-13
Cerner Corporation [CERNER CORP.]
CareAware Blood Bank Device Driver2011-04-13
Cerner Corporation [CERNER CORP.]
CareAware Beds Device Driver2011-04-13
Cerner Corporation [CERNER CORP.]
CareAware Balloon Pumps Device Driver2011-04-13
Cerner Corporation [CERNER CORP.]
CareAware Anesthesia Device Driver2011-04-13
Cerner Corporation [CERNER CORP.]
CareAware AlertLink2011-04-13
Cerner Corporation [CERNER CORP.]
Bridge Transfusion Documentation Outbound Interface2011-04-13
Cerner Corporation [CERNER CORP.]
Bridge MedAdmin Details Interface2011-04-13
Cerner Corporation [CERNER CORP.]
Bridge MedAdmin Clinical Observations Interface2011-04-13
Cerner Corporation [CERNER CORP.]
AI-CN (Siemens Centaur)2011-04-13
Cerner Corporation [CERNER CORP.]
Cerner CareAware IBus2009-12-11
CERNER CORP.
Cerner CareAware IBus2009-12-11
CERNER CORP.
CERNER CAREAWARE IBUS2009-11-27
Cerner Corporation [CERNER CORP.]
FetaLink2009-10-27
CERNER CORP.
FetaLink2009-10-27
Cerner Corporation [CERNER CORP.]
Cerner SkyVue with Mammography2009-10-27
CERNER CORP.
Cerner SkyVue with Mammography2009-10-27
CERNER CORP.
CERNER FETALINK (VERSION 1.0)2009-08-25
CERNER CORP.
CERNER PROVISION WORKSTATION (VERSION 2.5)2009-06-22
Cerner Corporation [CERNER CORP.]
Cerner SkyVue2007-11-13
CERNER CORP.
Cerner SkyVue2007-11-13
SHELLEY S LOOBY [CERNER CORP.]
Cerner Bridge Medical Transfusion Administration and Specimens Collection2007-11-13
CERNER CORP.
Cerner Bridge Medical Transfusion Administration and Specimens Collection2007-11-13
Cerner Corporation [CERNER CORP.]
Novius Lab2007-08-02
Cerner Corporation [CERNER CORP.]
LIS/LAS Laboratory Automation System (interface)2007-08-02
Cerner Corporation [CERNER CORP.]
Cerner Millennium PathNet2007-08-02
Cerner Corporation [CERNER CORP.]
Cerner LabSequence2007-08-02
Cerner Corporation [CERNER CORP.]
Cerner HNAM Elecsysbd2007-08-02
Cerner Corporation [CERNER CORP.]
CERNER MILLENIUM PATH2007-08-02
CERNER CORP.
Novius Lab2007-08-02
CERNER CORP.
LIS/LAS Laboratory Automation System (interface)2007-08-02
CERNER CORP.
Cerner Millennium PathNet2007-08-02
CERNER CORP.
Cerner LabSequence2007-08-02
CERNER CORP.
Cerner HNAM Elecsysbd2007-08-02
CERNER CORP.
CERNER MILLENIUM PATH2007-08-02
Cerner Corporation
510(k) Premarket Notification // Quick Links: Skip To Main Page Content Skip To Search Skip To Topics Menu Skip To Common Links U.S. Food & Drug Administration   Follow FDA En Español Search FDA   Home Food Drugs Medical Devices 2007-05-24
CERNER CORP.
CERNER PROVISION WORKSTATION2007-03-27
SHELLEY S LOOBY [CERNER CORP.]
Cerner Millennium Blood Bank2006-11-01
Cerner Corporation [CERNER CORP.]
Cerner Millennium Blood Bank2006-11-01
CERNER CORP.
Cerner Millennium Blood Bank2006-11-01
SHELLEY S LOOBY [CERNER CORP.]
Cerner SkyVue Distribution2006-11-01
SHELLEY S LOOBY [CERNER CORP.]
Cerner Media Viewer2006-11-01
SHELLEY S LOOBY [CERNER CORP.]
Cerner Image Viewer2006-11-01
Cerner Corporation [CERNER CORP.]
Cerner SkyVue Distribution2006-11-01
Cerner Corporation [CERNER CORP.]
Cerner Media Viewer2006-11-01
Cerner Corporation [CERNER CORP.]
Cerner Image Viewer2006-11-01
CERNER CORP.
Cerner SkyVue Distribution2006-11-01
CERNER CORP.
Cerner Media Viewer2006-11-01
CERNER CORP.
Cerner Image Viewer2006-11-01
Cerner Corporation [CERNER CORP.]
CareAware MultiMedia Archive2002-01-29
CERNER CORP.
CareAware MultiMedia Archive2002-01-29
CERNER CORP.
PROVIEW MEDICAL IMAGE DISPLAY MODULE2000-05-16
Cerner Corporation
510(k) Premarket Notification // Quick Links: Skip To Main Page Content Skip To Search Skip To Topics Menu Skip To Common Links U.S. Food & Drug Administration   Follow FDA En Español Search FDA   Home Food Drugs Medical Devices 1999-11-02
Cerner Corporation
510(k) Premarket Notification // Quick Links: Skip To Main Page Content Skip To Search Skip To Topics Menu Skip To Common Links U.S. Food & Drug Administration   Follow FDA En Español Search FDA   Home Food Drugs Medical Devices 1997-07-16
Cerner Corporation
510(k) Premarket Notification // Quick Links: Skip To Main Page Content Skip To Search Skip To Topics Menu Skip To Common Links U.S. Food & Drug Administration   Follow FDA En Español Search FDA   Home Food Drugs Medical Devices 1997-07-16
Cerner Corporation
510(k) Premarket Notification // Quick Links: Skip To Main Page Content Skip To Search Skip To Topics Menu Skip To Common Links U.S. Food & Drug Administration   Follow FDA En Español Search FDA   Home Food Drugs Medical Devices 1997-07-16
Cerner Corporation
510(k) Premarket Notification // Quick Links: Skip To Main Page Content Skip To Search Skip To Topics Menu Skip To Common Links U.S. Food & Drug Administration   Follow FDA En Español Search FDA   Home Food Drugs Medical Devices 1997-07-16
CERNER CORP.
REMOTE VIEWING SYSTEM MEDICAL IMAGE DISPLAY MODULE1996-01-26

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