AHYDRON DENTAL CLEANING AGENT

FDA 510(k)

FDA Class 2 ·Dental

HELIOTINT

FDA 510(k)

FDA Class 2 ·Dental

SR-IVOSEAL

FDA 510(k)

FDA Class 2 ·Dental

EOS INLAY MATERIAL

FDA 510(k)

FDA Class 2 ·Dental

BASIC CALCIUM HYDROXIDE LINER

FDA 510(k)

FDA Class 2 ·Dental

Pulse-Generator, Pacemaker, External

FDA Pre-Market Approval

FDA Class 2 ·MODEL4553 MICRO-PACE,DUAL-CHAMBER,DDD TEMPORARY CARDIAC PACEMAKER

GPC Intramedullary Nailing Systems

FDA 510(k)

FDA Class 2 ·Orthopedic

Generator, Pulse, Pacemaker, External Programmable (For Electrophysiological Studies Only)

FDA Pre-Market Approval

FDA Class 2 ·MICRO-PACE MODEL 4553 DUAL CHAMBER DDD TEMPORARY CARDIAC PACEMAKER

Pulse-Generator, Pacemaker, External

FDA Pre-Market Approval

FDA Class 2 ·MICRO-PACE MODEL 4580 DUAL-CHAMBER,DDD,TEMPORARY CARDIAC PACEMAKER

MICADENT

FDA 510(k)

FDA Class 2 ·Dental

STERISAFE HP TABLE-TOP STEAM STERILIZER

FDA 510(k)

FDA Class 2 ·General Hospital

The Moses Express appliance

FDA 510(k)

FDA Class 2 ·Dental

THE MOSES ELITE APPLIANCE

FDA 510(k)

FDA Class 2 ·Dental

THE FRIENDLYLIGHT ND: YAG LASERS

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

LIGHTLANCE LASER SKIN PERFORATOR

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

DIASTAT ANTI CYCLIC CITRULLINATED PEPTIDE (ANTI-CCP) ELISA

FDA 510(k)

FDA Class 2 ·Immunology

ARCHITECT HOMOCYSTEINE REAGENTS, CALIBRATORS AND CONTROLS

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

Spiral Flow Peripheral Vascular Graft

FDA 510(k)

FDA Class 2 ·Cardiovascular

ARCHITECT ANTI-CCP (100 TEST), ARCHITECT ANTI-CCP (500 TEST), MODELS 1P65-25, 1P65-35

FDA 510(k)

FDA Class 2 ·Immunology

AXSYM HBA1C REAGENTS, AXSYM HBA1C CALIBRATORS, AXSYM HBA1C CONTROLS

FDA 510(k)

FDA Class 2 ·Hematology