12 results
·
23ms
·
Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
×
Change Healthcare Cardiology
FDA 510(k)
FDA Class 2
·Radiology
BD BBL™ Gram Decolorizer
FDA UDI
BECTON, DICKINSON AND COMPANY·00382902125280·BD BBL™ Gram Decolorizer, 3.8 L
BINAXNOW COVID-19 AG SELF TEST 2CT
FDA Adverse Event
Malfunction
·ABBOTT DIAGNOSTICS SCARBOROUGH, INC.·Product code QKP·January 12, 2023
BINAXNOW COVID-19 AG SELF TEST 2CT
FDA Adverse Event
Malfunction
·ABBOTT DIAGNOSTICS SCARBOROUGH, INC.·Product code QKP·January 16, 2023
ICE
FDA 510(k)
FDA Class 2
·Dental
ELECSYS T4 CALCHECK 5
FDA 510(k)
FDA Class 1
·Clinical Chemistry
STEALTHSTATION TREON PLUS
FDA Adverse Event
Death
·MEDTRONIC NAVIGATION, INC.·Product code HAW·October 24, 2008
HOMECHOICE
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE - LARGO·Product code FKX·August 16, 2011
ENDOTAK RELIANCE
FDA Adverse Event
Injury
·CPI - DEL CARIBE·Product code NVY·July 9, 2013
MEDTRONIC TRANSCATHETER VALVE
FDA Adverse Event
Injury
·MEDTRONIC HEART VALVES DIVISION·Product code NPT·December 5, 2020
ATLAS GOLD
FDA Adverse Event
Malfunction
·BARD PERIPHERAL VASCULAR, INC.·Product code DQY·December 18, 2023
DRX Revolution Mobile X-Ray System
FDA Enforcement
Class II
·Ongoing·Carestream Health, Inc.·December 13, 2023