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

Applied Biosystems™ TaqPath™ COVID-19, Flu A, Flu B, RSV Select Panel

FDA 510(k)
FDA Class 2 ·Microbiology

cobas liat SARS-CoV-2 & Influenza A/B v2 nucleic acid test

FDA 510(k)
FDA Class 2 ·Microbiology

ORTHODONTIC CERAMIC BRACKET

FDA 510(k)
FDA Class 2 ·Dental

SMR Reverse HP Shoulder System

FDA 510(k)
FDA Class 2 ·Orthopedic

Sensor, Pressure, Aneurysm, Implantable

FDA classification
FDA Class 2 ·Sensor, Pressure, Aneurysm, Implantable

ID NOW COVID-19 2.0

FDA 510(k)
FDA Class 2 ·Microbiology

cobas SARS-CoV-2 Nucleic acid test for use on the cobas Liat System

FDA 510(k)
FDA Class 2 ·Microbiology

Sofia 2 SARS Antigen+ FIA; Sofia 2 SARS Antigen+ FIA Control Swab Set

FDA 510(k)
FDA Class 2 ·Microbiology

BinaxNOW COVID-19 Ag Card

FDA 510(k)
FDA Class 2 ·Microbiology

BD Veritor System for SARS-CoV-2

FDA 510(k)
FDA Class 2 ·Microbiology

SCoV-2 Ag Detect Rapid Test

FDA 510(k)
FDA Class 2 ·Microbiology

Healgen Rapid COVID-19 Antigen Test

FDA 510(k)
FDA Class 2 ·Microbiology

cobas liat SARS-CoV-2 v2 nucleic acid test

FDA 510(k)
FDA Class 2 ·Microbiology

Sofia 2 SARS Antigen+ FIA, Sofia 2 SARS Antigen+ FIA Control Swab Set

FDA 510(k)
FDA Class 2 ·Microbiology

Nano-Check™ COVID-19 Antigen Test

FDA 510(k)
FDA Class 2 ·Microbiology

Detector, Ultraviolet

FDA classification
FDA Class 2 ·Detector, Ultraviolet

Sars-Cov-2 Serology Test

FDA classification
FDA Class 2 ·Sars-Cov-2 Serology Test

Suture, Nonabsorbable, Steel, Monofilament And Multifilament, Sterile, Exempt

FDA classification
FDA Class 2 ·Suture, Nonabsorbable, Steel, Monofilament And Multifilament, Sterile, Exempt

Lens, Contact (Other Material) - Daily

FDA Pre-Market Approval
FDA Class 2 ·FLUOROPERM (PAFLUFOCON A) RGP CONTACT LENS

Lens, Contact (Orthokeratology)

FDA Pre-Market Approval
FDA Class 2 ·FLUOROPERM 60 RIGID GAS PERMEABLE CONTACT LENSES