DZIDRA GLASS FOR USE IN NEUROLOGY

FDA 510(k)

CHOLESITE TEST SYSTEM

FDA 510(k)

FDA Class 1 ·Clinical Chemistry

FULL BREATH SLEEP APPLIANCE - PB (POSTERIOR BITE AND PBB (POSTERIOR BITE WITH BUMPS)

FDA 510(k)

FDA Class 2 ·Dental

GDS ENZYMATIC ACETAMINOPHEN REAGENT

FDA 510(k)

FDA Class 2 ·Clinical Toxicology

KETOSITE(TM)/STAT-SITE(TM)/KETOSITE(TM) LOW-HI CON

FDA 510(k)

FDA Class 1 ·Clinical Chemistry

GDS ENZYMATIC SALICYLATE REAGENT

FDA 510(k)

FDA Class 2 ·Clinical Toxicology

DZIDRA GLASS FOR USE IN GENERAL MEDICAL

FDA 510(k)

GBrain MRI

FDA 510(k)

FDA Class 2 ·Radiology

DZIDRA GLASS FOR USE IN DENTISTRY

FDA 510(k)

Mitral Valve Repair Devices

FDA Pre-Market Approval

FDA Class 3 ·MitraClip G4 System

Mitral Valve Repair Devices

FDA Pre-Market Approval

FDA Class 3 ·MitraClip G4 Clip Delivery System; MitraClip G5 Delivery System

Tricuspid Valve Repair Device, Percutaneously Delivered

FDA Pre-Market Approval

FDA Class 3 ·TriClip G4 Delivery System;TriClip G5 Delivery System

ANGELITE FAMILY OF INTENSE PULSED LIGHT SYSTEMS, MODELS ANGELITE-DDC AND ANGELITE-SDC

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

ATL CO2 MEDICAL LASER SYSTEMS, MODELS ATL-150 AND ATL-250

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

Q-SWITCHED ND:YAG LASER SYSTEM, MODEL GLOBALCURE-SC6

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

DC-7 DIAGNOSTIC ULTRASOUND SYSTEM

FDA 510(k)

FDA Class 2 ·Radiology

CO2 LASER SYSTEM

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

DC-T6 DIAGNOSTIC ULTRASOUND SYSTEM

FDA 510(k)

FDA Class 2 ·Radiology

DC-3/DC-3T DIAGNOSTIC ULTRASOUND SYSTEM

FDA 510(k)

FDA Class 2 ·Radiology

DC-8/ DC-8 PRO/ DC-8 CV/ DC-8 EXP/ DC-8S DIAGNOSTIC ULTRASOUND SYSTEMS

FDA 510(k)

FDA Class 2 ·Radiology