927 results
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28ms
·
Sources: EU EUDAMED, US FDA
Filters
Classification: FDA Class 2
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OARtrac System with Skin Sensors
FDA 510(k)
FDA Class 2
·Radiology
ADVOCATE DUO BLOOD GLUCOSE PLUS BLOOD PRESSURE MONITORING SYSTEM, MODEL TD-3223
FDA 510(k)
FDA Class 2
·Clinical Chemistry
MAXIMED EXICHEK TD-4224 BLOOD GLUCOSE MONITORING SYSTEM
FDA 510(k)
FDA Class 2
·Clinical Chemistry
TAIDOC CHECK
FDA 510(k)
FDA Class 2
·Clinical Chemistry
Corporate Dental Imaging (CDI) Application
FDA 510(k)
FDA Class 2
·Radiology
Accessories, Soft Lens Products
FDA Pre-Market Approval
FDA Class 2
·VIS-SOL STERILE PRESERVED SALINE SOLUTION
Accessories, Soft Lens Products
FDA Pre-Market Approval
FDA Class 2
·ISOTONIC STERILE UNPRESERVED SALINE SOLUTION
Accessories, Soft Lens Products
FDA Pre-Market Approval
FDA Class 2
·VIS-SOL STERILE PRESERVED SALINE SOLUTION
Accessories, Soft Lens Products
FDA Pre-Market Approval
FDA Class 2
·ISOTONIC STERILE UNPRESERVED SALINE SOLUTION
AxSOS 3 AF System and AxSOS 3 Ti System
FDA 510(k)
FDA Class 2
·Orthopedic
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