46 results
·
22ms
·
Sources: EU EUDAMED, US FDA
The IQool System
FDA 510(k)
FDA Class 2
·Cardiovascular
TRU-MR LARYNGOSCOPE SET
FDA 510(k)
FDA Class 1
·Anesthesiology
MULTI-LEAD TRIALING CABLE MODEL 355531
FDA 510(k)
FDA Class 2
·Neurology
INDIGO SYSTEM ASPIRATION CATHETER D
FDA Adverse Event
Malfunction
·PENUMBRA, INC.·Product code DXE·February 12, 2019
INDIGO SYSTEM SEPARATOR D
FDA Adverse Event
Malfunction
·PENUMBRA, INC.·Product code DXE·April 18, 2018
AIRVO TUBE AND CHAMBER KIT WITH NEBULIZER ADAPTER
FDA Adverse Event
Malfunction
·FISHER & PAYKEL HEALTHCARE LTD·Product code BTT·November 23, 2021
AIRVO TUBE AND CHAMBER KIT WITH NEBULIZER ADAPTER
FDA Adverse Event
Malfunction
·FISHER & PAYKEL HEALTHCARE LTD·Product code BTT·April 18, 2022
INDIGO SYSTEM CATD ASPIRATION CATHETER
FDA Adverse Event
Malfunction
·PENUMBRA, INC.·Product code DXE·May 29, 2019
INDIGO SYSTEM CATD ASPIRATION CATHETER
FDA Adverse Event
Malfunction
·PENUMBRA, INC.·Product code DXE·January 17, 2020
AIRVO2 TUBE AND CHAMBER KIT WITH NEBULIZER ADAPTER
FDA Adverse Event
Malfunction
·FISHER & PAYKEL HEALTHCARE LTD·Product code BTT·January 18, 2022
INDIGO SYSTEM ASPIRATION CATHETER D
FDA Adverse Event
Malfunction
·PENUMBRA, INC.·Product code DXE·December 7, 2018
INDIGO SYSTEM ASPIRATION CATHETER D
FDA Adverse Event
Malfunction
·PENUMBRA, INC.·Product code QEW·January 29, 2021
INDIGO SYSTEM ASPIRATION CATHETER D
FDA Adverse Event
Malfunction
·PENUMBRA, INC.·Product code DXE·December 10, 2020
PENUMBRA SYSTEM JETD REPERFUSION CATHETER
FDA Adverse Event
Malfunction
·PENUMBRA, INC.·Product code DXE·June 5, 2019
INDIGO SYSTEM CATD ASPIRATION CATHETER
FDA Adverse Event
Malfunction
·PENUMBRA, INC.·Product code DXE·January 25, 2019
INDIGO SYSTEM CATD ASPIRATION CATHETER
FDA Adverse Event
Malfunction
·PENUMBRA, INC.·Product code DXE·January 25, 2019
INDIGO SYSTEM CATD ASPIRATION CATHETER
FDA Adverse Event
Malfunction
·PENUMBRA, INC.·Product code DXE·July 28, 2020
INDIGO SYSTEM ASPIRATION CATHETER D
FDA Adverse Event
Malfunction
·PENUMBRA, INC.·Product code DXE·July 29, 2020
INDIGO SYSTEM CATD ASPIRATION CATHETER
FDA Adverse Event
Malfunction
·PENUMBRA, INC.·Product code DXE·September 11, 2020
INDIGO SYSTEM CATD ASPIRATION CATHETER
FDA Adverse Event
Malfunction
·PENUMBRA, INC.·Product code DXE·September 24, 2019