STAT PROFILE PHOX CO-OXIMETER ANALYZER, NOVA CO-OXIMETER CONTROLS, LEVELS 1 AND 2, NOVA CO-OXIMETER THB CALIBRATOR

FDA 510(k)

FDA Class 2 ·Hematology

VDRIVE SYSTEM/ VDRIVE DUO/ VDRIVE WITH V-CAS

FDA 510(k)

FDA Class 2 ·Cardiovascular

QUICK RELAX PRO

FDA 510(k)

FDA Class 2 ·Neurology

AVANCE FOAM DRESSING KITS

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

BD VERITOR SYSTEM FOR THE RAPID DETECTION OF FLU A+B

FDA 510(k)

FDA Class 2 ·Microbiology

ARENA-C

FDA 510(k)

FDA Class 2 ·Orthopedic

BIOMET ACCESS SYSTEM

FDA 510(k)

FDA Class 2 ·Ear, Nose, Throat

CERTAIN BELLATEK PROVISIONAL ABUTMENTS

FDA 510(k)

FDA Class 2 ·Dental

HARDYDISK AMIKACIN 30MCG

FDA 510(k)

FDA Class 2 ·Microbiology

AQUAMANTYS3 9.5 XL BIPOLAR SEALER

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

Echo Bi-Metric Microplasty Hip System

FDA 510(k)

FDA Class 2 ·Orthopedic

BIOPHOTAS LIFELIGHT

FDA 510(k)

FDA Class 2 ·Physical Medicine

HARDY DISK, CEFPODOXINE, 10MCG

FDA 510(k)

FDA Class 2 ·Microbiology

MILTEX THOMPSON CASSETTES; MILTEX SURGICAL CASSETTES

FDA 510(k)

FDA Class 2 ·General Hospital

Cue COVID-19 Molecular Test

FDA 510(k)

FDA Class 2 ·Microbiology

Cue COVID-19 Molecular Test

FDA 510(k)

FDA Class 2 ·Microbiology

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

FDA 510(k)

FDA Class 2 ·Microbiology

BIOFIRE® SPOTFIRE® Respiratory (R) Panel Mini

FDA 510(k)

FDA Class 2 ·Microbiology

BIOFIRE SPOTFIRE Respiratory/Sore Throat (R/ST) Panel

FDA 510(k)

FDA Class 2 ·Microbiology

Panther Fusion SARS-CoV-2/Flu A/B/RSV Assay

FDA 510(k)

FDA Class 2 ·Microbiology