8 results
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21ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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FORTRESS Radiopaque Bone Cement (FORTRESS and FORTRESS-Plus), CREO® Fenestrated Screw System, REVLOK® Fenestrated Screw System
FDA 510(k)
FDA Class 2
·Orthopedic
ANGIOJET ULTRA DVX THROMBECTOMY SET, MODEL: 106552
FDA 510(k)
FDA Class 2
·Cardiovascular
ELECSYS IGE CALCHECK 5
FDA 510(k)
FDA Class 1
·Clinical Chemistry
ONETOUCHPING GLUCOSEMGMTSYSTEM
FDA Adverse Event
Malfunction
·ANIMAS CORPORATION·Product code LZG·July 22, 2011
UNIVERSAL MODULAR ELECTRIC/BATTERY SINGLE
FDA Adverse Event
Malfunction
·ZIMMER SURGICAL S.A.·Product code GFA·June 5, 2013
ANALYTICAL P MODULE
FDA Adverse Event
Malfunction
·ROCHE DIAGNOSTICS·Product code JJE·September 19, 2008
PANTHER FUSION ADV/HMPV/RV ASSAY
FDA Adverse Event
Injury
·HOLOGIC INCORPORATED·Product code OCC·October 12, 2021
BINAXNOW COVID-19 AG SELF TEST 2CT
FDA Adverse Event
Malfunction
·ABBOTT DIAGNOSTICS SCARBOROUGH, INC.·Product code QKP·August 23, 2023