EpiFaith CV

FDA 510(k)

FDA Class 2 ·Cardiovascular

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

Analyzer, Medical Image

FDA Pre-Market Approval

FDA Class 2 ·CLEARREAD DETECT

Catheters, Transluminal Coronary Angioplasty, Percutaneous

FDA Pre-Market Approval

FDA Class 2 ·MAVERICK PTCA CATHETERS

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

BU-CAD

FDA 510(k)

FDA Class 2 ·Radiology

VS Tabletop Tonometer

FDA 510(k)

FDA Class 2 ·Ophthalmic

Assay, Hybridization And/Or Nucleic Acid Amplification For Detection Of Hepatitis C Rna,Hepatitis C Virus

FDA Pre-Market Approval

FDA Class 2 ·COBAS AMPLIPREP/COBAS TAQMAN HCV TEST V2.0

CPRMETER CPR FEEDBACK DEVICE

FDA 510(k)

FDA Class 2 ·Cardiovascular

LORI HEARING AID SIMULATOR

FDA 510(k)

FDA Class 2 ·Ear, Nose, Throat

RIONET HEARING AID

FDA 510(k)

FDA Class 2 ·Ear, Nose, Throat