44 results
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37ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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TransContinental® M Spacers and InterContinental® Plate-Spacers
FDA 510(k)
FDA Class 2
·Orthopedic
ADVANCE TOTAL KNEE SYSTEM
FDA 510(k)
FDA Class 2
·Orthopedic
SPECTRALIS HRA+OCT, SPECTRALIS FA_OCT, SPECTRALIS ICGA+ OCT, SPECTRALIS HRA, SPECTRALIS FA
FDA 510(k)
FDA Class 2
·Ophthalmic
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
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
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
OT VERIO IQ METER
FDA Adverse Event
Malfunction
·LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL·Product code NBW·June 11, 2013
TELIGEN
FDA Adverse Event
Injury
·GUIDANT CRM CLONMEL IRELAND·Product code LWS·July 13, 2011
FLO-GARD 6201 VOLUMETRIC INFUSION PUMP
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE·Product code FRN·September 17, 2008