MAX-IF1000

FDA 510(k)

FDA Class 2 ·Neurology

FLUORCANASITE DENTAL CERAMIC

FDA 510(k)

FDA Class 2 ·Dental

VIVOSORB SHEET, MODEL FS01

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

REUSABLE STIMULATING ELECTRODES

FDA 510(k)

FDA Class 2 ·Neurology

GLYCARTISSUE REPAIR PATCH FAMILY OF PRODUCTS; GLYCAR VASCULAR REPAIR PATCH ALTERNATIVE PROPRIETARY NAME POSSIBLE

FDA 510(k)

FDA Class 2 ·Cardiovascular

PUTMAN STABILIZER

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

NEUROLAC NERVE GUIDE MODELS NG01-15/03, NG01-020/03, NG01 025/03, NG01-030/03

FDA 510(k)

FDA Class 2 ·Neurology

AIRPERFECT 1000 (SINGLE-USER SYSTEM), AIRPERFECT 2000 (MULTI-USER SYSTEM)

FDA 510(k)

FDA Class 2 ·Cardiovascular

DTX-100 BONE DENSITOMETER

FDA 510(k)

FDA Class 2 ·Radiology

NEUROLAC NERVE GUIDE

FDA 510(k)

FDA Class 2 ·Neurology

NASOPORE EAR

FDA 510(k)

FDA Class 2 ·Ear, Nose, Throat

Prostate-Specific Antigen (Psa) For Management Of Prostate Cancers

FDA Pre-Market Approval

FDA Class 2 ·ACCESS HYBRITECH PSA ON THE SYNCHRON LXI 725 SYSTEM

DURATECH HOSPITAL TOWEL

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

OTOGRAM, CA3350

FDA 510(k)

FDA Class 2 ·Ear, Nose, Throat

DTX-200 BONE DENSITOMETER

FDA 510(k)

FDA Class 2 ·Radiology

Exablate Prostate System

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

SMART WAVE GS100

FDA 510(k)

FDA Class 2 ·Physical Medicine

MDX 2000, DIGITAL ANALYZER

FDA 510(k)

FDA Class 2 ·Hematology

Analyzer, Medical Image

FDA Pre-Market Approval

FDA Class 2 ·IMAGECHECKER LX AND IMAGECHECKER DX (SOFTWARE VERSION 6.0)

UNSCENTED MENSTRUAL TAMPON

FDA 510(k)

FDA Class 2 ·Obstetrics/Gynecology