Diode Laser Machine, Model Number: BM-100

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

Advanced Intelligent Volumetric Ultrasound System, Model AiVUS 1000

FDA 510(k)

FDA Class 2 ·Radiology

Balloon Inflation System

FDA 510(k)

FDA Class 2 ·Orthopedic

Personal Lubricant

FDA 510(k)

FDA Class 2 ·Obstetrics/Gynecology

NuCath Wedge Pressure Catheter

FDA 510(k)

FDA Class 2 ·Cardiovascular

Disposable Powered Articulating Endoscopic Linear Cutter Stapler & Reloads (30mm series); Disposable Powered Articulating Endoscopic Linear Cutter Stapler & Reloads (45mm series); Disposable Powered Articulating Endoscopic Linear Cutter Stapler & Reloads (60mm series)

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

Zirdent Dental Zirconia Blank & Dental Zirconia Pre-Shaded Blank

FDA 510(k)

FDA Class 2 ·Dental

High Performance Liquid Chromatography For Cyclosporine

FDA Pre-Market Approval

FDA Class 2 ·BIO-RAD CYCLOSPORINE BY HPLC TEST

Scooter

FDA 510(k)

FDA Class 2 ·Physical Medicine

BIO-LOGIC EVOKED POTENTIAL FOR ABAER I

FDA 510(k)

FDA Class 2 ·Neurology

MODIFICATION TO BIO-LOGIC EVOKED POTENTIAL FOR ABAER/ NAVIGATOR PRO.

FDA 510(k)

FDA Class 2 ·Neurology

AUDIOMETER

FDA 510(k)

FDA Class 2 ·Ear, Nose, Throat

BIO-LOGIC INSERT EARPHONES

FDA 510(k)

FDA Class 2 ·Ear, Nose, Throat

BIO-LOGIC SLEEPSCAN PRODUCT WITH BUILT-IN OXIMETER

FDA 510(k)

FDA Class 2 ·Anesthesiology

STACKED ABR FOR NAVIGATOR PRO

FDA 510(k)

FDA Class 2 ·Neurology

BIO-LOGIC CEEGRAPH 128-CHANNEL RECORDING SYSTEM

FDA 510(k)

FDA Class 2 ·Neurology

BIO-LOGIC ABAER CUB

FDA 510(k)

FDA Class 2 ·Neurology

MODIFICATION TO BIO-LOGIC SLEEPSCAN

FDA 510(k)

FDA Class 2 ·Neurology

ENZYMATIC ALPHA-AMYLASE REAGENT KIT

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

SPORT/AUDX OAE TEST INSTRUMENT WITH BIO-LOGIC EAR PROBE

FDA 510(k)

FDA Class 2 ·Ear, Nose, Throat