8 results
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20ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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V8/H8 Diagnostic Ultrasound System, V7/H7 Diagnostic Ultrasound System, V6/H6 Diagnostic Ultrasound System
FDA 510(k)
FDA Class 2
·Radiology
CANTATA(R) 2.9 MICROCATHETER
FDA 510(k)
FDA Class 2
·Cardiovascular
TI FENESTRATED PLATE
FDA 510(k)
FDA Class 2
·Orthopedic
CANTATA 2.9 SUPERSELECTIVE MICROCATHETER
FDA Adverse Event
Malfunction
·COOK INC·Product code KRA·September 14, 2017
SENSOR ENLITE
FDA Adverse Event
Injury
·MEDTRONIC MINIMED·Product code OZO·November 6, 2014
COLLEAGUE
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE - SINGAPORE·Product code FRN·September 1, 2011
TRUERESULT
FDA Adverse Event
Malfunction
·NIPRO DIAGNOSTICS, INC.·Product code NBW·July 15, 2013
Revogene, Catalog no. 610210. IVD test instrument
FDA Enforcement
Class II
·Ongoing·Meridian Bioscience Inc·August 3, 2022