11 results
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25ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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ARIX Pectus Bar System
FDA 510(k)
FDA Class 2
·Orthopedic
TandemHeart Pump and Escort Controller
FDA 510(k)
FDA Class 2
·Cardiovascular
Chang Gung ComMed Series Dental Implant System
FDA 510(k)
FDA Class 2
·Dental
ALARIS SYSTEM
FDA Adverse Event
Malfunction
·CAREFUSION SD·Product code FRN·November 2, 2023
HEMOSPHERE ALTA
FDA Adverse Event
Malfunction
·EDWARDS LIFESCIENCES·Product code QAQ·November 18, 2025
HEMOSPHERE ALTA
FDA Adverse Event
Malfunction
·EDWARDS LIFESCIENCES·Product code QAQ·August 20, 2025
HEMOSPHERE ALTA
FDA Adverse Event
Malfunction
·EDWARDS LIFESCIENCES·Product code QAQ·November 18, 2025
PARADIGM REAL-TIME INSULIN INFUSION PUMP
FDA Adverse Event
Malfunction
·MEDTRONIC PUERTO RICO OPERATIONS CO.·Product code OYC·November 11, 2014
RIATA ST ACTIVE FIXATION
FDA Adverse Event
Injury
·ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION·Product code NVY·September 10, 2011
GYNECARE TVT RETROPUBIC SYSTEM
FDA Adverse Event
Injury
·ETHICON INC.·Product code OTN·July 23, 2013
HEMOSPHERE ALTA
FDA Adverse Event
Malfunction
·EDWARDS LIFESCIENCES·Product code QAQ·November 18, 2025