191 results
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
ROCHE MOLECULAR SYSTEMS, INC.
FDA registration
ROCHE MOLECULAR SYSTEMS, INC.·48 products·🇺🇸 United States
FUSION FAST
FDA 510(k)
FDA Class 2
·Dental
VERTEX Reconstruction System
FDA 510(k)
FDA Class 2
·Orthopedic
COBAS AMPLIPREP / COBAS TAQMAN HIV-1 TEST, VERSION 2.0 CE-IVD
FDA Adverse Event
ROCHE MOLECULAR SYSTEMS·Product code MZF·July 2, 2013
COBAS AMPLIPREP / COBAS TAQMAN HIV-1 TEST, VERSION 2.0 CE-IVD
FDA Adverse Event
ROCHE MOLECULAR SYSTEMS·Product code MZF·July 2, 2013
COBAS AMPLIPREP / COBAS TAQMAN HIV-1 TEST, VERSION 2.0 CE-IVD
FDA Adverse Event
ROCHE MOLECULAR SYSTEMS·Product code MZF·July 2, 2013
COBAS AMPLIPREP / COBAS TAQMAN HIV-1 TEST, VERSION 2.0 CE-IVD
FDA Adverse Event
ROCHE MOLECULAR SYSTEMS·Product code MZF·July 2, 2013
COBAS AMPLIPREP / COBAS TAQMAN HIV-1 TEST, VERSION 2.0 CE-IVD
FDA Adverse Event
ROCHE MOLECULAR SYSTEMS·Product code MZF·July 2, 2013
2243471-2019-00014
FDA Adverse Event
Malfunction
·March 26, 2019
2243471-2019-00013
FDA Adverse Event
Malfunction
·March 21, 2019
COBAS SARS-COV-2 & INFLUENZA A/B TEST FOR USE ON THE COBAS LIAT SYSTEM
FDA Adverse Event
Malfunction
·ROCHE MOLECULAR SYSTEMS, INC. - BRANCHBURG·Product code QJR·July 8, 2021
COBAS SARS-COV-2 & INFLUENZA A/B TEST FOR USE ON THE COBAS LIAT SYSTEM
FDA Adverse Event
Malfunction
·ROCHE MOLECULAR SYSTEMS, INC. - BRANCHBURG·Product code QJR·July 16, 2021
COBAS SARS-COV-2 & INFLUENZA A/B TEST FOR USE ON THE COBAS LIAT SYSTEM
FDA Adverse Event
Malfunction
·ROCHE MOLECULAR SYSTEMS, INC. - BRANCHBURG·Product code QJR·July 15, 2021
COBAS LIAT SYSTEM
FDA Adverse Event
Malfunction
·ROCHE MOLECULAR SYSTEMS, INC. - BRANCHBURG·Product code OCC·March 27, 2021
COBAS SARS-COV-2 & INFLUENZA A/B TEST FOR USE ON THE COBAS LIAT SYSTEM
FDA Adverse Event
Malfunction
·ROCHE MOLECULAR SYSTEMS, INC. - BRANCHBURG·Product code QJR·July 14, 2021
COBAS LIAT SYSTEM
FDA Adverse Event
Malfunction
·ROCHE MOLECULAR SYSTEMS, INC. - BRANCHBURG·Product code OCC·March 27, 2021
COBAS LIAT SYSTEM
FDA Adverse Event
Malfunction
·ROCHE MOLECULAR SYSTEMS, INC. - BRANCHBURG·Product code OCC·March 27, 2021
COBAS LIAT SYSTEM
FDA Adverse Event
Malfunction
·ROCHE MOLECULAR SYSTEMS, INC. - BRANCHBURG·Product code OCC·March 27, 2021
COBAS SARS-COV-2 & INFLUENZA A/B TEST FOR USE ON THE COBAS LIAT SYSTEM
FDA Adverse Event
Malfunction
·ROCHE MOLECULAR SYSTEMS, INC. - BRANCHBURG·Product code QJR·June 21, 2021