AVIVAFIX CONDUCTIVE GARMENT-KNEE/SHOULDER/UPPER BACK, TYPE 40

FDA 510(k)

FDA Class 2 ·Neurology

CHARTER GUIDEWIRE MODEL 45-281, 45-282, 45-283

FDA 510(k)

FDA Class 2 ·Cardiovascular

INJEKT CYSTO FLEXIBLE INJECTION NEEDLE

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

VICTORY GUIDEWIRE (32 MODELS)

FDA 510(k)

FDA Class 2 ·Cardiovascular

Wearable Device, Home Package in Carry Case with Homehub, Home Package in Carry Case without Homehub

FDA 510(k)

FDA Class 2 ·Cardiovascular

Wearable Device, Wearable Package

FDA 510(k)

FDA Class 2 ·Cardiovascular

ResQ Administration Set

FDA 510(k)

FDA Class 2 ·General Hospital

Assay, Enzyme Linked Immunosorbent, Hepatitis C Virus

FDA Pre-Market Approval

FDA Class 2 ·VITROS IMMUNODIAGNOSTIC PRODUCTS ANTI-HCV REAGENT PACK AND CALIBRATOR

XeliteMed VertehighFix High Viscosity Spinal Bone Cement

FDA 510(k)

FDA Class 2 ·Orthopedic

PixoTest POCT System - PixoTest POCT Analyzer and PixoTest A1c Test Kit

FDA 510(k)

FDA Class 2 ·Hematology

XeliteMed VertehighFix High Viscosity Spinal Bone Cement System

FDA 510(k)

FDA Class 2 ·Orthopedic

PixoTest POCT System - PixoTest POCT Analyzer and PixoTest A1c Test Kit

FDA 510(k)

FDA Class 2 ·Hematology

Mico One Orthodontic Screw

FDA 510(k)

FDA Class 2 ·Dental

Monobond Etch & Prime

FDA 510(k)

FDA Class 2 ·Dental

B.Light Clear Evo and B.Light Restore Evo

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

Tetric CAD

FDA 510(k)

FDA Class 2 ·Dental

CYTOPREP

FDA 510(k)

FDA Class 2 ·Obstetrics/Gynecology

Barrier Sleeves

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

Telio CAD Abutment Solutions

FDA 510(k)

FDA Class 2 ·Dental

Bemer Therapy System Evo

FDA 510(k)

FDA Class 2 ·Physical Medicine