12 results
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22ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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Sofia Lyme FIA, Sofia Lyme Control Set
FDA 510(k)
FDA Class 2
·Microbiology
MODULAR HEAD HIP SYSTEM
FDA UDI
Biomet Orthopedics, LLC·00880304256910·
Modular Head Hip System
FDA UDI
Biomet Orthopedics, LLC·00887868310898·
ID NOW COVID-19 ASSAY
FDA Adverse Event
Malfunction
·ABBOTT DIAGNOSTICS SCARBOROUGH, INC.·Product code QJR·November 17, 2021
ID NOW COVID-19 ASSAY
FDA Adverse Event
Malfunction
·ABBOTT DIAGNOSTICS SCARBOROUGH, INC.·Product code QJR·November 17, 2021
OSSIX BONE, OSSIX PLUS
FDA Adverse Event
Injury
·DATUM DENTAL LTD.·Product code NPM·June 22, 2022
ELTA WOUND CLEANSER
FDA 510(k)
FDA Unclassified
·Unknown
AMS SMART SLING SYSTEM
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
ACCU-CHEK ® AVIVA TEST STRIPS
FDA Adverse Event
Malfunction
·ROCHE DIAGNOSTICS·Product code LFR·July 15, 2011
RESERVOIR 1.8ML
FDA Adverse Event
Malfunction
·MEDTRONIC PUERTO RICO OPERATIONS CO.·Product code FRN·June 11, 2013
530G INSULIN PUMP
FDA Adverse Event
Injury
·MEDTRONIC PUERTO RICO OPERATIONS CO.·Product code OZO·October 10, 2014
ID NOW COVID-19 ASSAY
FDA Adverse Event
Malfunction
·ABBOTT DIAGNOSTICS SCARBOROUGH, INC.·Product code QJR·November 17, 2021