27 results
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22ms
·
Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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Dexcom G6 Continuous Glucose Monitoring (CGM) System, Dexcom G6 Glucose Program Continuous Glucose Monitoring (CGM) System, Dexcom G6 Professional Continuous Glucose Monitoring (CGM) System
FDA 510(k)
FDA Class 2
·Clinical Chemistry
UniTip High Resolution Catheter
FDA UDI
Unisensor AG·07640172970423·
UniTip High Resolution Catheter
FDA UDI
Unisensor AG·07640172970393·
UniTip High Resolution Catheter
FDA UDI
Unisensor AG·07640172970416·
UniTip High Resolution Catheter
FDA UDI
Unisensor AG·07640172970409·
ORTHOLOC 2 with 3Di Technology Pilon Fracture Plating System
FDA 510(k)
FDA Class 2
·Orthopedic
Renamel Bulkfill
FDA 510(k)
FDA Class 2
·Dental
ID NOW COVID-19 ASSAY
FDA Adverse Event
Malfunction
·ABBOTT DIAGNOSTICS SCARBOROUGH, INC.·Product code QJR·April 15, 2021
ID NOW COVID-19 ASSAY
FDA Adverse Event
Malfunction
·ABBOTT DIAGNOSTICS SCARBOROUGH, INC.·Product code QJR·April 15, 2021
ID NOW COVID-19 ASSAY
FDA Adverse Event
Malfunction
·ABBOTT DIAGNOSTICS SCARBOROUGH, INC.·Product code QJR·April 15, 2021
CAPTURE-R READY-ID
FDA Adverse Event
Malfunction
·IMMUCOR, INC.·Product code KSZ·December 12, 2014
ACRYSOF RESTOR
FDA Adverse Event
Injury
·ALCON RESEARCH, LTD. / HUNTINGTON·Product code MFK·November 5, 2008
PARADIGM REAL-TIME INSULIN INFUSION PUMP
FDA Adverse Event
Injury
·MEDTRONIC PUERTO RICO OPERATIONS MED-REL·Product code MDS·August 17, 2011
PINNACLE MTL INS NEUT36IDX52OD
FDA Adverse Event
Injury
·DEPUY ORTHOPAEDICS, INC. 1818910·Product code KWA·July 11, 2013
ID NOW COVID-19 ASSAY
FDA Adverse Event
Malfunction
·ABBOTT DIAGNOSTICS SCARBOROUGH, INC.·Product code QJR·April 15, 2021
ID NOW COVID-19 ASSAY
FDA Adverse Event
Injury
·ABBOTT DIAGNOSTICS SCARBOROUGH, INC.·Product code QJR·April 21, 2021
ID NOW COVID-19 ASSAY
FDA Adverse Event
Malfunction
·ABBOTT DIAGNOSTICS SCARBOROUGH, INC.·Product code QJR·April 21, 2021
ID NOW COVID-19 ASSAY
FDA Adverse Event
Malfunction
·ABBOTT DIAGNOSTICS SCARBOROUGH, INC.·Product code QJR·April 21, 2021
ID NOW COVID-19 ASSAY
FDA Adverse Event
Malfunction
·ABBOTT DIAGNOSTICS SCARBOROUGH, INC.·Product code QJR·April 14, 2021
ID NOW COVID-19 ASSAY
FDA Adverse Event
Malfunction
·ABBOTT DIAGNOSTICS SCARBOROUGH, INC.·Product code QJR·April 21, 2021