14 results
·
33ms
·
Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
×
Ambra Health Mobile Application
FDA UDI
Ambra Health·AMBRMOBILEAPP0·Mobile Application version of Ambra Health. Not...
Ambra PACS
FDA UDI
Ambra Health·AMBRHEALTHSOLUTIONS0·
Ambra PACS
FDA UDI
Ambra Health·AMBRAPACS0·
DICOM Grid (dba Ambra Health)
FDA registration
DICOM Grid (dba Ambra Health)·2 products·🇺🇸 United States
Ambra PACS, Ambra ProViewer. Software for use as a primary diagnostic and analysis tool for diagnostic images.
FDA Recall
Open, Classified
·DICOM Grid, Inc. d/b/a Ambra Health·Product code LLZ·June 23, 2022
AMBRA
FDA Adverse Event
Malfunction
·DICOM GRID DBA AMBRA HEALTH DBA INTELERAD HOLDING·Product code LLZ·December 30, 2024
Ambra PACS, Ambra ProViewer. Software for use as a primary diagnostic and analysis tool for diagnostic images.
FDA Enforcement
Class II
·Ongoing·DICOM Grid, Inc. d/b/a Ambra Health·October 5, 2022
AMARA FULL FACE MASK
FDA Adverse Event
Death
·RESPIRONICS, INC.·Product code BZD·April 25, 2022
AMARA VIEW MASK
FDA Adverse Event
Injury
·PHILIPS NORTH AMERICA LLC·Product code BZD·December 8, 2022
NATRELLE 410
FDA Adverse Event
Injury
·ALLERGAN·Product code FTR·September 1, 2017
AMARA VIEW
FDA Adverse Event
Malfunction
·RESPIRONICS, INC.·Product code BZD·July 9, 2025
ESSURE
FDA Adverse Event
Injury
·BAYER·Product code HHS·September 25, 2017
EVIS EXERA III GASTROINTESTINAL VIDEOSCOPE
FDA Adverse Event
Malfunction
·OLYMPUS MEDICAL SYSTEMS CORP.·Product code FDS·June 23, 2022
MEDTRONIC PRESTIGE ARTIFICIAL DISC
FDA Adverse Event
Injury
·MEDTRONIC SOFAMOR DANEK·Product code MJO·June 2, 2010