390 results
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33ms
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Sources: EU EUDAMED, US FDA
Filters
Classification: FDA Class 2
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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
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
HIVOX SPOPAD EMS
FDA 510(k)
FDA Class 2
·Physical Medicine
ALL SILICONE HEMATURIA CATHETER, MODELS 4861, 4862, 4863, 4864, 4865
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
DIGITAL CLINICAL THERMOMETER/MODELS ST8C SERIES
FDA 510(k)
FDA Class 2
·General Hospital
LED Curing Light GT-2000
FDA 510(k)
FDA Class 2
·Dental