9 results
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23ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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CREATINE KINASE-MB (CK-MB) REAGENT SET
FDA 510(k)
FDA Class 2
·Clinical Chemistry
ACTIVATED PARTIAL THROMBOPLASTIN TIME
FDA 510(k)
FDA Class 2
·Hematology
GENERAL MEDICAL PROCEDURE KIT/SKIN PREPARATION
FDA 510(k)
FDA Class 2
·General Hospital
MENTOR SMOOTH ROUND MODERATE PROFILE
FDA Adverse Event
Injury
·MENTOR TEXAS·Product code FWM·September 16, 2019
OMNIPOD INSULIN MANAGEMENT SYSTEM
FDA Adverse Event
Malfunction
·INSULET CORPORATION·Product code LZG·June 9, 2020
ZENITH FENESTRATED AAA ENDOVASCULAR GRAFT PROXIMAL BODY
FDA Adverse Event
Injury
·WILLIAM A. COOK AUSTRALIA·Product code MIH·June 23, 2014
SM304 M-SERIES W/ZOOM
FDA Adverse Event
Malfunction
·STRYKER MEDICAL·Product code INK·January 4, 2013
BATTERY
FDA Adverse Event
Malfunction
·STRYKER INSTRUMENTS KALAMAZOO·Product code KIJ·December 13, 2010
MENTOR SMOOTH ROUND MODERATE PROFILE
FDA Adverse Event
Injury
·MENTOR TEXAS·Product code FWM·November 13, 2025