18 results
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26ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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CONI
FDA 510(k)
FDA Class 2
·Radiology
INVENDO C20 COLONOSCOPY SYSTEM
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
MODIFICATION TO FABIUS GS ANESTHESIA SYSTEM
FDA 510(k)
FDA Class 2
·Anesthesiology
EARLYVUE VS30 VITAL SIGNS MONITOR
FDA Adverse Event
Malfunction
·PHILIPS NORTH AMERICA LLC·Product code DSJ·September 15, 2021
EARLYVUE VS30 VITAL SIGNS MONITOR
FDA Adverse Event
Malfunction
·PHILIPS NORTH AMERICA LLC·Product code DSJ·March 1, 2022
VENTED AUTOFEED CHAMBER
FDA Adverse Event
Malfunction
·FISHER & PAYKEL HEALTHCARE LTD·Product code BTT·April 11, 2014
EARLYVUE VS30 VITAL SIGNS MONITOR
FDA Adverse Event
Malfunction
·PHILIPS NORTH AMERICA LLC·Product code DSJ·August 1, 2022
2520274-2013-02807
FDA Adverse Event
Injury
·SYNTHES USA·Product code MQV·May 24, 2013
UNIDENTIFIED ASR CUP
FDA Adverse Event
Injury
·DEPUY INTERNATIONAL LTD. 8010379·Product code KWA·September 30, 2014
ENRHYTHM DR
FDA Adverse Event
Injury
·MEDTRONIC MED REL, INC.·Product code DXY·June 16, 2011
EARLYVUE VS30 VITALS MONITOR
FDA Adverse Event
Malfunction
·PHILIPS MEDIZIN SYSTEME BÖBLINGEN GMBH·Product code DSJ·June 14, 2021
EARLYVUE VS30 VITALS MONITOR
FDA Adverse Event
Malfunction
·PHILIPS MEDICAL SYSTEMS·Product code MHX·July 29, 2021
ADULT DUAL HEATED EVAQUA BREATHING CIRCUIT
FDA Adverse Event
Malfunction
·FISHER & PAYKEL HEALTHCARE LIMITED·Product code BZE·October 16, 2013
ADULT DUAL HEATED EVAQUA BREATHING CIRCUIT
FDA Adverse Event
Malfunction
·FISHER & PAYKEL HEALTHCARE LTD·Product code BZE·February 17, 2014
ADULT DUAL HEATED EVAQUA BREATHING CIRCUIT
FDA Adverse Event
Malfunction
·FISHER & PAYKEL HEALTHCARE LIMITED·Product code BZE·October 28, 2013
VENTED AUTOFEED CHAMBER
FDA Adverse Event
Malfunction
·FISHER & PAYKEL HEALTHCARE LIMITED·Product code BTT·March 18, 2014
VENTED HUMIDIFICATION CHAMBER
FDA Adverse Event
Malfunction
·FISHER & PAYKEL HEALTHCARE LTD·Product code BTT·November 6, 2013
Eversense CGM SENSOR (FG-4200-00-301)-Continuous Glucose Monitor
FDA Enforcement
Class II
·Terminated·Senseonics, Inc.·November 6, 2019