35 results
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35ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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Tiger® Occipital-Cervical-Thoracic Spinal Fixation System
FDA 510(k)
FDA Class 2
·Orthopedic
CARTO XP AND QWIKMAP EP NAVIGATION SYSTEM
FDA 510(k)
FDA Class 2
·Cardiovascular
AeroEclipse* ONE BAN
FDA 510(k)
FDA Class 2
·Anesthesiology
COLLEAGUE CX VOLUMETRIC INFUSION PUMP
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE PTE. LTD.·Product code FRN·October 20, 2008
SPECTRUM CENTRAL VENOUS CATHETER SET
FDA Adverse Event
Malfunction
·COOK MEDICAL·Product code FOZ·June 21, 2013
VASO VIEW HEMOPRO
FDA Adverse Event
Injury
·MAQUET CARDIOVASCULAR, LLC·Product code GEI·August 8, 2011
QUICK SET PARADIGM
FDA Adverse Event
Malfunction
·UNOMEDICAL A/S·Product code FPA·November 2, 2009
INSPIRE 7F M HOLLOW FIBER OXYGENATOR WITH INTEGRATED ARTERIAL FILTER
FDA Adverse Event
Injury
·SORIN GROUP ITALIA SRL·Product code DTZ·September 15, 2022
INSPIRE 7F M HOLLOW FIBER OXYGENATOR WITH INTEGRATED ARTERIAL FILTER
FDA Adverse Event
Malfunction
·SORIN GROUP ITALIA SRL.·Product code DTZ·March 12, 2024
INSPIRE 7F
FDA Adverse Event
Malfunction
·SORIN GROUP ITALIA SRL·Product code DTZ·June 24, 2025
INSPIRE 7F
FDA Adverse Event
Malfunction
·SORIN GROUP ITALIA·Product code DTZ·February 5, 2025
SCREW,FIXATION,BONE
FDA Adverse Event
Injury
·WRIGHTS LANE SYNTHES USA PRODUCTS LLC·Product code HWC·February 21, 2019
SCREW, FIXATION, BONE
FDA Adverse Event
Injury
·WRIGHTS LANE SYNTHES USA PRODUCTS LLC·Product code HWC·February 21, 2019
SCREW, FIXATION, BONE
FDA Adverse Event
Injury
·WRIGHTS LANE SYNTHES USA PRODUCTS LLC·Product code HWC·February 21, 2019
SCREW, FIXATION, BONE
FDA Adverse Event
Injury
·WRIGHTS LANE SYNTHES USA PRODUCTS LLC·Product code HWC·February 19, 2019
PLATE, FIXATION, BONE
FDA Adverse Event
Injury
·WRIGHTS LANE SYNTHES USA PRODUCTS LLC·Product code HRS·February 21, 2019
SCREW,FIXATION,BONE
FDA Adverse Event
Injury
·WRIGHTS LANE SYNTHES USA PRODUCTS LLC·Product code HWC·February 21, 2019
SCREW,FIXATION,BONE
FDA Adverse Event
Injury
·WRIGHTS LANE SYNTHES USA PRODUCTS LLC·Product code HWC·February 21, 2019
SCREW,FIXATION,BONE
FDA Adverse Event
Injury
·WRIGHTS LANE SYNTHES USA PRODUCTS LLC·Product code HWC·February 21, 2019
PLATE,FIXATION,BONE
FDA Adverse Event
Injury
·WRIGHTS LANE SYNTHES USA PRODUCTS LLC·Product code HRS·February 19, 2019