926 results · 31ms · Sources: EU EUDAMED, US FDA

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