21 results · 24ms · Sources: EU EUDAMED, US FDA

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CONSEAL F

FDA 510(k)
FDA Class 2 ·Dental

Revolution Centrifugal Blood Pump

FDA 510(k)
FDA Class 2 ·Cardiovascular

SPSMEDICAL VAPORIZED HYDROGEN PEROXIDE CHEMICAL INDICATORS

FDA 510(k)
FDA Class 2 ·General Hospital

POWERED WHEELCHAIR

FDA Adverse Event
Malfunction ·INVACARE TAYLOR STREET·Product code ITI·March 5, 2013

STARCLOSE SE VASCULAR CLOSURE SYSTEM

FDA Adverse Event
Injury ·AV-TEMECULA-CT·Product code MGB·February 15, 2011

PRECISION SPECTRA®

FDA Adverse Event
Injury ·BOSTON SCIENTIFIC NEUROMODULATION·Product code LGW·August 8, 2014

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

NASAL-AIRE

FDA Adverse Event
Malfunction ·INNOMED TECHNOLOGIES·Product code BYE·January 6, 2003

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

EMBRYO RPLCMNT CATHETER

FDA Adverse Event
Malfunction ·COOPERSURGICAL, INC.·Product code MQF·September 24, 2019

BARD Dynamic Deca Steerable, Product Number 201101; REPROCESSED ELECTROPHYSIOLOGY CATHETER

FDA Enforcement
Class II ·Ongoing·Stryker Sustainability Solutions·May 20, 2026