9 results
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24ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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Freedom Wrist Arthroplasty System
FDA 510(k)
FDA Class 2
·Orthopedic
PHILIPS IQON SPECTRAL CT
FDA 510(k)
FDA Class 2
·Radiology
MULTIGENT HEMOGLOBIN A1C (REAGENTS), HB A1C CALIBRATORS AND HB A1C CONTROLS
FDA 510(k)
FDA Class 2
·Hematology
ALARIS SYSTEM
FDA Adverse Event
Malfunction
·CAREFUSION SD·Product code FRN·September 27, 2023
530G INSULIN PUMP
FDA Adverse Event
Malfunction
·MEDTRONIC PUERTO RICO OPERATIONS CO.·Product code OZO·November 6, 2014
COLLEAGUE
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE - SINGAPORE·Product code FRN·September 2, 2011
GYNECARE PROLIFT ANTERIOR PELVIC FLOOR REPAIR SYSTEM
FDA Adverse Event
Injury
·ETHICON SARL·Product code OTP·July 18, 2013
CAPSURE EPICARDIAL LEAD
FDA Adverse Event
Injury
·MPRI·Product code DTB·July 18, 2025
AZURE XT DR MRI SURESCAN
FDA Adverse Event
Injury
·MEDTRONIC SINGAPORE OPERATIONS·Product code NVZ·July 18, 2025