1,741 results · 30ms · Sources: EU EUDAMED, US FDA

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

DREAM COLOR I (POLYMACON) SOFT (HYDROPHILIC) CONTACT LENS, DREAM COLOR II (POLYMACON) SOFT (HYDROPHILIC) CONTACT LENS, D

FDA 510(k)
FDA Class 2 ·Ophthalmic

SD GLUCONAVII MENTOR NFC MULTI BLOOD GLUCOSE MONITORING SYSTEM, AND SD GLUCONAVII MENTOR NFC BLOOD GLUCOSE MONITORING SYSTEM

FDA 510(k)
FDA Class 2 ·Clinical Chemistry

Z-RAY INTRA-ORAL DIGITAL RADIOGRAPHY SYSTEM

FDA 510(k)
FDA Class 2 ·Dental

NOVEL PRINT CYAN ALGINATES

FDA 510(k)
FDA Class 2 ·Dental

ID MILLENNIUM, ID MOMENTS SILICONE

FDA 510(k)
FDA Class 2 ·Obstetrics/Gynecology

FEMMYCYCLE

FDA 510(k)
FDA Class 2 ·Obstetrics/Gynecology

QUICKPROFILE SINGLE DRUG OF ABUSE DEVICE AND QUICK PROFILE MULTI-DRUGS OF ABUSE SCREEN DEVICE

FDA 510(k)
FDA Class 2 ·Clinical Toxicology

FITPACK

FDA 510(k)
FDA Class 2 ·General Hospital

AVANA DENTAL IMPLANT SYSTEM

FDA 510(k)
FDA Class 2 ·Dental

SPACER

FDA 510(k)
FDA Class 2 ·Dental

Racz Neurostat RF Generator

FDA 510(k)
FDA Class 2 ·Neurology

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