SEPACELL R-500 AND SEPACELL R-500A

FDA 510(k)

FDA Class 2 ·General Hospital

MODIFIED AM-SERIES DIALYZERS

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

SUPER SOOTHER

FDA 510(k)

FDA Class 2 ·General Hospital

NeuroSwift Pro

FDA 510(k)

FDA Class 2 ·Neurology

ACCENTO / HWA Dual/Single laser

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

EpiFaith CV

FDA 510(k)

FDA Class 2 ·Cardiovascular

HOYA Illumina (sorafilcon A) Daily Disposable Soft Contact Lens, HOYA Illumina (sorafilcon A) Toric Daily Disposable Soft Contact Lens, HOYA Illumina (sorafilcon A) Multifocal Daily Disposable Soft Contact Lens

FDA 510(k)

FDA Class 2 ·Ophthalmic

Lucid Q-PTP / HWA 55

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

BR-ABVS Viewer 1.0

FDA 510(k)

FDA Class 2 ·Radiology

Vigeon Laparoscopic Universal Smoke Evacuator (VG003)

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

GIM-STIM OTC TENS/EMS System

FDA 510(k)

FDA Class 2 ·Neurology

AcroDTI Visualizer

FDA 510(k)

FDA Class 2 ·Radiology

TOTAL BILIRUBIN L3K, MODEL 295-10 AND 295-30

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

ACETAMINOPHEN L3K ASSAY, AND ACETAMINOPHEN L3K ASSAY, MODELS 506-10, 506-30

FDA 510(k)

FDA Class 2 ·Clinical Toxicology

GEMORE OTC TENS

FDA 510(k)

FDA Class 2 ·Neurology

MiiS Horus Eye Anterior Camera

FDA 510(k)

FDA Class 2 ·Ophthalmic

TEMP MASTER, PMMA-based dental resin

FDA 510(k)

FDA Class 2 ·Dental

VersaVue Single-Use Flexible Cystoscope, VersaVue Tablet, and VersaVue Video Box

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

ENT Nasopharyngoscope and Accessories

FDA 510(k)

FDA Class 2 ·Ear, Nose, Throat

EpiFaith Syringe

FDA 510(k)

FDA Class 2 ·General Hospital