578 results
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31ms
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Sources: EU EUDAMED, US FDA
Filters
Classification: FDA Class 2
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Parky App
FDA 510(k)
FDA Class 2
·Neurology
Altera gas Sampling Lines
FDA 510(k)
FDA Class 2
·Anesthesiology
FlowArt Valve for Vial Access
FDA 510(k)
FDA Class 2
·General Hospital
Altera Filter and HME/Filter
FDA 510(k)
FDA Class 2
·Anesthesiology
PMSSteripack Tyvek Sterilization Pouch (TP) and Roll (TY) with Chemical Indicator
FDA 510(k)
FDA Class 2
·General Hospital
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
3DOSE 1ml Syringe
FDA 510(k)
FDA Class 2
·General Hospital
CureOs TCP
FDA 510(k)
FDA Class 2
·Orthopedic
MSFX MIKRON SPINAL FIXATION SYSTEM
FDA 510(k)
FDA Class 2
·Orthopedic
Bioscope Neuromonitor Device
FDA 510(k)
FDA Class 2
·Ear, Nose, Throat
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