Cerner CareAware Event Management
CERNER CORPORATION
Cerner Corporation
FDA Registration(s)#
| Registration | FEI | Name | Status | Initial importer | Expiration year | Address |
|---|---|---|---|---|---|---|
| 3013546957 | 3013546957 | Cerner Corporation | 1 | Y | 2026-01-01 | 8779 Hillcrest Rd Kansas City MO US 64138 |
| 1931259 | 1931259 | CERNER CORP. | 1 | Y | 2020-04-25 | 2800 ROCKCREEK PKWY. KANSAS CITY MO US 64117 |
Registered Device Listings#
| Registration key | Listing key | Premarket submission | Device | Product code | Decision date |
|---|---|---|---|---|---|
| 205855 | 1935751258 | K151672 | Cerner CareAware Event Management | MSX | 2015-12-21 |
| 49484 | 1935751258 | K151672 | Cerner CareAware Event Management | MSX | 2015-12-21 |
| 205855 | 1282718517 | K121758 | CERNER FETALINK+(VERSION1.0) | HGM | 2012-10-09 |
| 49484 | 1282718517 | K121758 | CERNER FETALINK+(VERSION1.0) | HGM | 2012-10-09 |
| 49484 | 1779216332 | K093134 | CERNER CAREAWARE IBUS | DRG | 2009-11-27 |
| 205855 | 1779216332 | K093134 | CERNER CAREAWARE IBUS | DRG | 2009-11-27 |
| 49484 | 1870312463 | K091251 | CERNER FETALINK (VERSION 1.0) | HGM | 2009-08-25 |
| 205855 | 1870312463 | K091251 | CERNER FETALINK (VERSION 1.0) | HGM | 2009-08-25 |
| 205855 | 1110173579 | K091032 | CERNER PROVISION WORKSTATION (VERSION 2.5) | LLZ | 2009-06-22 |
| 49484 | 1110173579 | K091032 | CERNER PROVISION WORKSTATION (VERSION 2.5) | LLZ | 2009-06-22 |
| 205855 | 1776113157 | K070394 | CERNER PROVISION WORKSTATION | LLZ | 2007-03-27 |
| 49484 | 1776113157 | K070394 | CERNER PROVISION WORKSTATION | LLZ | 2007-03-27 |
| 49484 | 1042978903 | BK990007 | |||
| 205855 | 1042978903 | BK990007 | |||
| 49484 | 1145749660 | BK060037 | |||
| 205855 | 1145749660 | BK060037 | |||
| 205855 | 1105987083 | ||||
| 49484 | 1122935017 | ||||
| 205855 | 1122935017 | ||||
| 49484 | 1150812024 | ||||
| 205855 | 1150812024 | ||||
| 49484 | 1233804023 | ||||
| 49484 | 1594655978 | ||||
| 49484 | 1657281168 | ||||
| 49484 | 2009575362 | ||||
| 205855 | 2009575362 | ||||
| 205855 | 1657281168 |
Product Codes Associated With Registrations#
PMN#
CERNER FETALINK+(VERSION1.0)
CERNER CORP.
CERNER CAREAWARE IBUS
CERNER CORP.
CERNER FETALINK (VERSION 1.0)
CERNER CORP.
CERNER PROVISION WORKSTATION (VERSION 2.5)
CERNER CORP.
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
Cerner Corporation
CERNER PROVISION WORKSTATION
CERNER CORP.
PROVIEW MEDICAL IMAGE DISPLAY MODULE
CERNER CORP.
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
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
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
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
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
Cerner Corporation
REMOTE VIEWING SYSTEM MEDICAL IMAGE DISPLAY MODULE
CERNER CORP.
GUDID#
FetaLink+ - FL+Android1
2025-07-03
FetaLink - FetaLink 200
2025-04-21
Cerner FetaLink - FetaLink200
2019-05-01
FetaLink® - FetaLink2014
2016-08-05
FetaLink+ - FetaLink+6
2019-05-01
FetaLink+® - FetaLink+3
2016-08-05
FetaLink® - FetaLink2013
2016-08-05
FetaLink+® - FetaLink+4
2017-01-16
FetaLink+ - FetaLink+5
2018-03-09
Cerner CareAware Event Management - CareAwareEventManagement5
2016-09-24
Cerner CareAware Event Management - CareAwareEventManagement6
2016-09-24
FetaLink+ - FL+7
2024-05-24
Cerner Motion Health - MotionHealth2016.22
2017-07-27
Oracle Health Patient Observer - CPO-SP7
2020-12-14
Oracle Health Patient Observer - CPO-I415
2020-01-31
Oracle Patient Observer - CPO-SP
2019-09-30
Oracle Health Patient Observer - CPO-SP4
2019-09-30
Oracle Health Patient Observer - CPO-SP6
2019-09-30
Soarian Device Connect - CernerSDCv2.0
2016-07-16
Oracle Health Blood Bank - PathNet Blood Bank Transfusion2015
2016-08-05
Oracle Health Blood Bank - PathNet Blood Bank Transfusion 2012
2016-08-05
Oracle Health Transfusion Administration and Bridge Specimen Collection - Bridge2016
2016-09-24
NOVIUS Lab - Laboratory Information System application software
2018-02-14
Oracle Health Blood Bank - PathNet Blood Bank Transfusion 2018
2017-05-08
Cerner CareAware iBus - CareAwareiBus6
2016-09-24
Cerner SkyVue® - SkyVue2014
2016-08-05
Cerner SkyVue® - SkyVue4
2017-07-31
Cerner CareAware iBus - CareAwareiBus5
2016-09-24