21 results
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24ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: 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