83 results
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22ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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SORIN VVR 4000I AND 4000I SMARXT FILTERED HARDSHELL VENOUS RESERVOIR
FDA 510(k)
FDA Class 2
·Cardiovascular
SORIN VVR 4000I AND 4000I SMARXT FILTERED HARDSHELL VENOUS RESERVOIR
FDA Adverse Event
Death
·SORIN GROUP ITALIA SRL·Product code DTN·October 3, 2016
Zavation
FDA UDI
Zavation LLC·00842166146181·eZspand PLIF/T-PLIF 9x23x15°, 7-11.5mm
Zavation
FDA UDI
Zavation LLC·00842166146334·eZspand PLIF/T-PLIF 9x23x15°, 8.5-13mm
Zavation
FDA UDI
Zavation LLC·00842166146488·eZspand PLIF/T-PLIF 9x23x15°, 10.5-15mm
EndoPilot cable for file clamp
FDA UDI
Schlumbohm GmbH & Co. KG·04260482990893·cable for file clamp for EndoPilot
WISEBANDS SKIN CLOSURE DEVICE
FDA 510(k)
FDA Class 1
·General, Plastic Surgery
LEVEEN ELECTRODE
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
PERFUSOR®
FDA Adverse Event
Malfunction
·B BRAUN MELSUNGEN AG·Product code FRN·April 10, 2025
PERFUSOR®
FDA Adverse Event
Malfunction
·B BRAUN MELSUNGEN AG·Product code FRN·May 5, 2025
PERFUSOR®
FDA Adverse Event
Malfunction
·B BRAUN MELSUNGEN AG·Product code FRN·May 13, 2026
PERFUSOR®
FDA Adverse Event
Malfunction
·B BRAUN MELSUNGEN AG·Product code FRN·April 14, 2026
PERFUSOR®
FDA Adverse Event
Malfunction
·B BRAUN MELSUNGEN AG·Product code FRN·May 18, 2026
PERFUSOR®
FDA Adverse Event
Malfunction
·B BRAUN MELSUNGEN AG·Product code FRN·May 19, 2025
PERFUSOR®
FDA Adverse Event
Malfunction
·B BRAUN MELSUNGEN AG·Product code FRN·May 19, 2025
PERFUSOR®
FDA Adverse Event
Malfunction
·B BRAUN MELSUNGEN AG·Product code FRN·April 8, 2025
PERFUSOR®
FDA Adverse Event
Malfunction
·B BRAUN MELSUNGEN AG·Product code FRN·March 30, 2026
PERFUSOR®
FDA Adverse Event
Malfunction
·B BRAUN MELSUNGEN AG·Product code FRN·March 31, 2026
ENDURANT II
FDA Adverse Event
Injury
·MEDTRONIC IRELAND·Product code MIH·May 3, 2013
6F ANGIO-SEAL VASCULAR CLOSURE DEVICE VIP
FDA Adverse Event
Injury
·ST. JUDE MEDICAL·Product code MGB·August 19, 2014