19 results · 24ms · Sources: EU EUDAMED, 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