SPRINT PNS System

FDA 510(k)

FDA Class 2 ·Neurology

ANSiStim-PP

FDA 510(k)

FDA Class 2 ·Neurology

Smartpatch PNS MicroLead and Accessories, Smartpatch PNS Stimulator, Pads, and Accessories, Smartpatch PNS MicroLead and Introducer, Smartpatch PNS Pads, 4 Packs

FDA 510(k)

FDA Class 2 ·Neurology

SPRINT PNS System

FDA 510(k)

FDA Class 2 ·Neurology

SpermAlign Sperm Separation Device

FDA 510(k)

FDA Class 2 ·Obstetrics/Gynecology

OpClear System

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

OpClear Platform (CU3 DI3), OpClear Control Unit with Footswitch (CS-CU33), OpClear Disposable Procedure Kits (CS-10-00-300, CS-10-30-300, CS-10-00-315, CS-10-30-315, CS-10-00-330, CS-10-30-330, CS-05-00-290, CS-05-30-290), Contd from 3 above: CS-05-00-300, CS-05-30-300, CS-05-00-315, CS-05-30-315

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

DYNAMESH -CICAT

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

R&G Surgical Mask

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

DREAM COLOR I (POLYMACON) SOFT (HYDROPHILIC) CONTACT LENS, DREAM COLOR II (POLYMACON) SOFT (HYDROPHILIC) CONTACT LENS, D

FDA 510(k)

FDA Class 2 ·Ophthalmic

SD GLUCONAVII MENTOR NFC MULTI BLOOD GLUCOSE MONITORING SYSTEM, AND SD GLUCONAVII MENTOR NFC BLOOD GLUCOSE MONITORING SYSTEM

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

Z-RAY INTRA-ORAL DIGITAL RADIOGRAPHY SYSTEM

FDA 510(k)

FDA Class 2 ·Dental

NOVEL PRINT CYAN ALGINATES

FDA 510(k)

FDA Class 2 ·Dental

ID MILLENNIUM, ID MOMENTS SILICONE

FDA 510(k)

FDA Class 2 ·Obstetrics/Gynecology

FEMMYCYCLE

FDA 510(k)

FDA Class 2 ·Obstetrics/Gynecology

QUICKPROFILE SINGLE DRUG OF ABUSE DEVICE AND QUICK PROFILE MULTI-DRUGS OF ABUSE SCREEN DEVICE

FDA 510(k)

FDA Class 2 ·Clinical Toxicology

FITPACK

FDA 510(k)

FDA Class 2 ·General Hospital

AVANA DENTAL IMPLANT SYSTEM

FDA 510(k)

FDA Class 2 ·Dental

SPACER

FDA 510(k)

FDA Class 2 ·Dental

HEARTSTART 2000, MANUAL DEFIBRILLATOR

FDA 510(k)

FDA Class 2 ·Cardiovascular