MDK MULTI-APPLICATIONS PLATFORM

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

Vertos mild Device Kit (MDK-0002)

FDA 510(k)

FDA Class 2 ·Orthopedic

Paper Sterilization Pouch and Roll(Sterilization Pouch Flat, Sterilization Pouch Gusseted, Sterilization Roll Flat and Sterilization Roll Gusseted)

FDA 510(k)

FDA Class 2 ·General Hospital

LUNDERQUIST WIRE GUIDE; DC WIRE GUIDE

FDA 510(k)

FDA Class 2 ·Cardiovascular

FORTEC MI-305 & 306 DIGITAL THERMOMETER

FDA 510(k)

FDA Class 2 ·General Hospital

BIOCELLECT

FDA 510(k)

FDA Class 2 ·Dental

MODIFICATION TO IMTEC SENDAX MDI

FDA 510(k)

FDA Class 2 ·Dental

IMTEC/TITANIUM MESH

FDA 510(k)

FDA Class 2 ·Dental

BIOCELLECT -PERIO

FDA 510(k)

FDA Class 2 ·Dental

IMTEC BIOPIN

FDA 510(k)

FDA Class 2 ·Dental

IMTEC BIOBARRIER MEMBRANE

FDA 510(k)

FDA Class 2 ·Dental

Kawasumi Laboratories Blood Drawing Kit (BDK) System

FDA 510(k)

FDA Class 2 ·Hematology

TCL3 Motion Tracking System

FDA 510(k)

FDA Class 2 ·Radiology

Analyzer, Medical Image

FDA Pre-Market Approval

FDA Class 2 ·IMAGECHECKER M1000 SYSTEM

Ultrasonic Doppler (Model YM-2T8)

FDA 510(k)

FDA Class 2 ·Obstetrics/Gynecology

EMS/TENS Massager Device

FDA 510(k)

FDA Class 2 ·Neurology

Pulse Oximeter

FDA 510(k)

FDA Class 2 ·Cardiovascular

Pulse Oximeter (Model C101A2, C101B1, C101A3)

FDA 510(k)

FDA Class 2 ·Cardiovascular

Arm Blood Pressure Monitor (model: BPM-A7VL)

FDA 510(k)

FDA Class 2 ·Cardiovascular

IMMULITE 2000 3RD GENERATION PSA

FDA 510(k)

FDA Class 2 ·Immunology