10 results
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19ms
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Sources: EU EUDAMED, US FDA
ESOPHAGEAL STETHO SCOPE
FDA 510(k)
FDA Class 2
·Anesthesiology
VITROS
FDA UDI
ORTHO CLINICAL DIAGNOSTICS·10758750030200·VITROS Immunodiagnostic Products
25-OH Vitamin ...
DYNASCOPE SERIES
FDA 510(k)
FDA Class 2
·Cardiovascular
VANADIUM EXCAVATORS SIZES 0-6
FDA 510(k)
FDA Class 1
·Dental
MENTOR SMOOTH ROUND HIGH PROFILE
FDA Adverse Event
Injury
·MENTOR TEXAS·Product code FWM·March 5, 2020
HOMECHOICE AUTOMATED PD SET WITH CASSETTE
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE - MOUNTAIN HOME·Product code FKX·June 2, 2014
POWERED WHEELCHAIR
FDA Adverse Event
Malfunction
·INVACARE SUZHOU·Product code ITI·November 24, 2012
TANDEM T:SLIM INSULIN DELIVERY SYSTEM
FDA Adverse Event
Malfunction
·TANDEM DIABETES CARE INC.·Product code LZG·June 12, 2015
VITROS Immunodiagnostic Products 25-OH Vitamin D Total Calibrators; REF/CATALOG # 684 4055, IVD --- COMMON/USUAL NAME: VITROS Vitamin D Calibrators -- Ortho-Clinical Diagnostics High Wycombe HP12 4DP, UK --- For use in the calibration of the VITROS ECi/ECiQ Immunodiagnostic Systems, the VITROS 3600 Immunodiagnostic Systems, and the VITROS 5600 Integrated System for the quantitative measurement of total 25-OH Vitamin D in human serum.
FDA Enforcement
Class III
·Terminated·Ortho-Clinical Diagnostics·March 19, 2014
VITROS Immunodiagnostic Products 25-OH Vitamin D Total Calibrators; REF/CATALOG # 684 4055, IVD --- COMMON/USUAL NAME: VITROS Vitamin D Calibrators -- Ortho-Clinical Diagnostics High Wycombe HP12 4DP, UK --- For use in the calibration of the VITROS ECi/ECiQ Immunodiagnostic Systems, the VITROS 3600 Immunodiagnostic Systems, and the VITROS 5600 Integrated System for the quantitative measurement of total 25-OH Vitamin D in human serum.
FDA Recall
Terminated
·Ortho-Clinical Diagnostics·Product code JIT·January 15, 2014