926 results
·
31ms
·
Sources: EU EUDAMED, US FDA
Filters
Classification: FDA Class 2
×
Lens, Contact (Other Material) - Daily
FDA Pre-Market Approval
FDA Class 2
·OCUSIL(R) (NEFOCON A) CONTACT LENSES ADD FIN LABS
Lens, Contact (Other Material) - Daily
FDA Pre-Market Approval
FDA Class 2
·OCUSIL(R) (NEFOCON A) CONTACT LENSES ADD FIN LABS
Lens, Contact (Other Material) - Daily
FDA Pre-Market Approval
FDA Class 2
·O-PERM F60 RGP CONTACT LENS ADD FINISH LABS
Assay, Hybridization And/Or Nucleic Acid Amplification For Detection Of Hepatitis C Rna,Hepatitis C Virus
FDA Pre-Market Approval
FDA Class 2
·VERSANT HCV RNA QUALITATIVE ASSAY/APTIMA HCV RNA QUALITATIVE ASSAY
System, Nucleic Acid Amplification, Mycobacterium Tuberculosis Complex
FDA Pre-Market Approval
FDA Class 2
·AMPLIFIED MTD (MYCOBACTERIUM TUBERCULOSIS DIRECT) TEST
Urology Videoscope System (Single-use Flexible Ureteroscope: SUV-1A-B, SUV-1A-P, SUV-2A-B, SUV-2A-P, SUV-2B-B, SUB-2B-P, SUV-2C-B, SUV-2C-P;Single-use Flexible Cystoscope: SUV-1D-B, SUV-1D-P; Endoscopic Image Processor: HDVS-S100A, HDVS-S100D.)
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
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
CPAP Cannulaide
FDA 510(k)
FDA Class 2
·Anesthesiology
HAND HELD NEBULIZER SYSTEM
FDA 510(k)
FDA Class 2
·Anesthesiology
MODELS 4002/4102/4202 OXY. DELIVERY/CO2 CANNULA
FDA 510(k)
FDA Class 2
·Anesthesiology