18 results
·
19ms
·
Sources: EU EUDAMED, US FDA
uAI Portal
FDA 510(k)
FDA Class 2
·Radiology
ESR-Chex Plus
FDA UDI
STRECK, INC.·00844509002192·A two-level hematology control used to monitor ...
X SERIES
FDA UDI
Zoll Medical Corporation·00847946019327·Defibrillator ,MAIN ASSY, X SERIES MONITOR/DEFI...
X SERIES
FDA UDI
Zoll Medical Corporation·00847946004439·Defibrillator ,MAIN ASSY, X SERIES MONITOR/DEFI...
X SERIES
FDA UDI
Zoll Medical Corporation·00847946012908·Defibrillator ,MAIN ASSY, X SERIES MONITOR/DEFI...
X SERIES
FDA UDI
Zoll Medical Corporation·00847946018863·Defibrillator ,MAIN ASSY, X SERIES MONITOR/DEFI...
X SERIES
FDA UDI
Zoll Medical Corporation·00847946015077·Defibrillator ,MAIN ASSY, X SERIES MONITOR/DEFI...
X SERIES
FDA UDI
Zoll Medical Corporation·00847946062262·X SERIES, MONITOR/DEFIBRILLATOR, 12 LD W/ INTER...
ALTERA SPACER
FDA 510(k)
FDA Class 2
·Orthopedic
DRI OXYCODONE ASSAY
FDA 510(k)
FDA Class 1
·Clinical Toxicology
LIBERTY CYCLER
FDA Adverse Event
Malfunction
·FRESENIUS MEDICAL CARE NORTH AMERICA·Product code FKX·May 2, 2013
BD CONVENTIONAL NEEDLES
FDA Adverse Event
Malfunction
·BECTON DICKINSON, S.A.·Product code FMI·July 31, 2024
ALARIS SYSTEM
FDA Adverse Event
Malfunction
·CAREFUSION SD·Product code FRN·October 27, 2023
OT PING METER
FDA Adverse Event
Malfunction
·LIFESCAN INC.·Product code NBW·September 9, 2011
COLLEAGUE 3CX VOLUMETRIC INFUSION PUMP
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE PTE. LTD.·Product code FRN·November 25, 2008
LOCKING TITANIUM ADAPTER
FDA Adverse Event
Malfunction
·KANAE CO.,LTD.·Product code KDJ·July 22, 2013
3mensio Workstation (Vascular Fenestrated) software
FDA Enforcement
Class II
·Ongoing·PIE Medical Imaging B.V.·August 20, 2025
Model Number L111, ESSENTIO DR SL MRI Pacemaker
FDA Enforcement
Class I
·Ongoing·Boston Scientific Corporation·October 22, 2025