491 results
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24ms
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Sources: EU EUDAMED, US FDA
Filters
Classification: FDA Class 2
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Xpert® Xpress CoV-2 plus
FDA 510(k)
FDA Class 2
·Microbiology
Alinity m SARS-CoV-2 AMP Kit (09N78-096); Alinity m SARS-CoV-2 CTRL Kit (09N78-086)
FDA 510(k)
FDA Class 2
·Microbiology
Applied Biosystems TaqPath COVID-19 Diagnostic PCR Kit
FDA 510(k)
FDA Class 2
·Microbiology
cobas® SARS-CoV-2 Qualitative for use on the cobas® 5800/6800/8800 Systems
FDA 510(k)
FDA Class 2
·Microbiology
BioFire COVID-19 Test 2
FDA 510(k)
FDA Class 2
·Microbiology
cobas SARS-CoV-2 Qualitative for use on the cobas 5800/6800/8800 Systems
FDA 510(k)
FDA Class 2
·Microbiology
Xpert® Xpress CoV-2 plus (XPRS-COV2-10)
FDA 510(k)
FDA Class 2
·Microbiology
BioFire COVID-19 Test 2
FDA 510(k)
FDA Class 2
·Microbiology
Aptima SARS-CoV-2 Assay
FDA 510(k)
FDA Class 2
·Microbiology
cobas SARS-CoV-2 Qualitative for use on the cobas 6800/8800 Systems
FDA 510(k)
FDA Class 2
·Microbiology
Simplexa COVID-19 Direct
FDA 510(k)
FDA Class 2
·Microbiology
External Counterpulsation System
FDA 510(k)
FDA Class 2
·Cardiovascular
Hisense LDC monitor models HMD2G21/HMD3G21/HMD5G21
FDA 510(k)
FDA Class 2
·Radiology
Hisense 2MP/3MP LCD Monitor (HMD2C21/HMD3C21)
FDA 510(k)
FDA Class 2
·Radiology
IPULSE, MODEL I400
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
iPulse SmoothSkin Gold Hair Removal Device, Venus Silk.expert
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
IPULSE HAIR REMOVAL SYSTEM
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
SmoothSkin BARE+
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
Fine Structure Analysis(fineSA)
FDA 510(k)
FDA Class 2
·Radiology
Braun Silk.expert Mini
FDA 510(k)
FDA Class 2
·General, Plastic Surgery