DPI-1106 IMPLANT, MODIFICATION

FDA 510(k)

FDA Class 2 ·Dental

2.1 x 255mm Drill, 22mm Stop

FDA 510(k)

FDA Class 2 ·Neurology

Galileo Vertebral Body Replacement Device

FDA 510(k)

FDA Class 2 ·Orthopedic

NAVIGUS UNIBODY FIDUCIAL MARKER SYSTEM, MODEL FM-4000

FDA 510(k)

FDA Class 2 ·Neurology

3I CERAMIC ABUTMENT SYSTEM

FDA 510(k)

FDA Class 2 ·Dental

VFC UNIT

FDA 510(k)

FDA Class 2 ·Radiology

LORENZ 1.5 X 4 MM LACTOSORB TAP FREE SCREW

FDA 510(k)

FDA Class 2 ·Dental

Mako Total Knee Application

FDA 510(k)

FDA Class 2 ·Neurology

reVive Light Therapy® Wrinkle and Acne LED Device

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

Catalyst F1x Shoulder System

FDA 510(k)

FDA Class 2 ·Orthopedic

ULTRABLATOR ELECTRODE

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

ADDITIONAL INDICATIONS FOR XOMED AUDIANT BONE CON.

FDA 510(k)

FDA Class 2 ·Ear, Nose, Throat

TEMPORARY PACING LEAD, SERIES TBB, MODEL HELIOS (TM)

FDA 510(k)

FDA Class 2 ·Cardiovascular

STRATUS CARDIAC TROPONIN-I FLUOROMETRIC ENZYME IMMUNMNOASSAY & STRATUS CARDIAC TROPONIN-I CALIBRATORS

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

Atlas Spine Rebar (Ti) Spacer System

FDA 510(k)

FDA Class 2 ·Orthopedic

KIS MT4

FDA 510(k)

FDA Class 2 ·Dental

CMV MICROASSAY

FDA 510(k)

FDA Class 2 ·Microbiology

APEX UNIVERSAL DRIVE SYSTEM

FDA 510(k)

FDA Class 2 ·Ear, Nose, Throat

RESUBMITTED BICARBONATE (CO2) REAGENT SINGLE VIAL

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

ARTHREX BIOCOMPOSITE TRANSFIX

FDA 510(k)

FDA Class 2 ·Orthopedic