19 results
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24ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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MIS Bunion Plating System
FDA 510(k)
FDA Class 2
·Orthopedic
U-RIGHT TD-3127 BLOOD PRESSURE MONITORING SYSTEM
FDA 510(k)
FDA Class 2
·Cardiovascular
SYNTHES EXTERNAL FIXATION DEVICES, MR CONDITIONAL
FDA 510(k)
FDA Class 2
·Orthopedic
SYR 10ML PUMP COMPATIBLE SALINE 10ML FIL
FDA Adverse Event
Malfunction
·BD MEDICAL (BD WEST) MEDICAL SURGICAL·Product code FMF·January 23, 2021
INSPIRA SMOOTH SILICONE GEL FILLED BREAST IMPLANT
FDA Adverse Event
Injury
·ALLERGAN (COSTA RICA)·Product code FTR·November 26, 2024
INFINITI VISION SYSTEM OZIL
FDA Adverse Event
Malfunction
·ALCON-IRVINE TECHNOLOGY CENTER·Product code HQC·June 21, 2013
INTERSTIM
FDA Adverse Event
Malfunction
·MPROC, JUNCOS·Product code EZW·October 6, 2008
X7000 XENON LIGHTSOURCE
FDA Adverse Event
Malfunction
·STRYKER ENDOSCOPY SAN JOSE·Product code FCW·July 27, 2011
REVOLUTION (ASSEMBLED INTO CUSTOMISED PERFUSION TUBING)
FDA Adverse Event
Malfunction
·SORIN GROUP ITALIA·Product code KFM·December 11, 2025
REVOLUTION CENTRIFUGAL BLOOD PUMP COATED
FDA Adverse Event
Malfunction
·SORIN GROUP ITALIA·Product code KFM·November 11, 2024
REVOLUTION CENTRIFUGAL BLOOD PUMP WITH PC COATING
FDA Adverse Event
Malfunction
·SORIN GROUP ITALIA SRL·Product code KFM·December 2, 2022
REVOLUTION PHISIO CENTRIFUGAL PUMP
FDA Adverse Event
Malfunction
·SORIN GROUP ITALIA SRL·Product code KFM·June 23, 2021
REVOLUTION PHISIO CENTRIFUGAL PUMP
FDA Adverse Event
Injury
·SORIN GROUP ITALIA SRL·Product code KFM·May 20, 2021
CENTRIFUGAL PUMP REVOLUTION 5
FDA Adverse Event
Malfunction
·SORIN GROUP ITALIA·Product code KFM·August 3, 2023
CENTRIFUGAL PUMP REVOLUTION 5
FDA Adverse Event
Malfunction
·SORIN GROUP ITALIA·Product code KFM·August 3, 2023
REVOLUTION CENTRIFUGAL BLOOD PUMP WITH PC COATING
FDA Adverse Event
Malfunction
·SORIN GROUP ITALIA SRL·Product code KFM·September 14, 2022
REVOLUTION CENTRIFUGAL BLOOD PUMP WITH PC COATING
FDA Adverse Event
Malfunction
·SORIN GROUP ITALIA SRL·Product code KFM·March 17, 2023
REVOLUTION CENTRIFUGAL BLOOD PUMP COATED
FDA Adverse Event
Malfunction
·SORIN GROUP ITALIA SRL·Product code KFM·June 19, 2025
REVOLUTION CENTRIFUGAL BLOOD PUMP
FDA Adverse Event
Injury
·SORIN GROUP ITALIA SRL·Product code KFM·March 19, 2022