Bio-TackS Orthodontic Mini Implant

FDA 510(k)

FDA Class 2 ·Dental

Kopac Sterile Needle

FDA 510(k)

FDA Class 2 ·General Hospital

YOGA Microcatheter, 0.032, 150cm, Back Up and Extra Back Up

FDA 510(k)

FDA Class 2 ·Cardiovascular

YOGA Microcatheter

FDA 510(k)

FDA Class 2 ·Cardiovascular

Suture Wing

FDA 510(k)

FDA Class 2 ·Orthopedic

Clear-Jet Injection Catheter

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

BODY COMPOSITION ANALYZER, MODELS: X-SCAN PLUS II, GAIA 359 PLUS, PLUSAVIS 333, XBIA 500, XBIA 900

FDA 510(k)

FDA Class 2 ·Cardiovascular

VENUS INTERBODY FIXATION SYSTEM- VENUS PLIF/TLIF, ALIF PEEK CAGE

FDA 510(k)

FDA Class 2 ·Orthopedic

EZ-Inject Single use Needle

FDA 510(k)

FDA Class 2 ·General Hospital

FOCUS SPINAL SYSTEM

FDA 510(k)

FDA Class 2 ·Orthopedic

LEXUS ANTERIOR CERVICAL PLATE SYSTEM

FDA 510(k)

FDA Class 2 ·Orthopedic

INFRARED EAR THERMOMETER, MODEL DX-707

FDA 510(k)

FDA Class 2 ·General Hospital

IVA Cage Ti (ACIF, PLIF, TLIF, DLIF, and ALIF)

FDA 510(k)

FDA Class 2 ·Orthopedic

SpermAlign Sperm Separation Device

FDA 510(k)

FDA Class 2 ·Obstetrics/Gynecology

AmorChem Titanium Porous Fixation Device

FDA 510(k)

FDA Class 2 ·Orthopedic

HARMONIE SENSA

FDA 510(k)

FDA Class 2 ·Neurology

OpClear System

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

HARMONIE SYSTEM

FDA 510(k)

FDA Class 2 ·Neurology

NOTTA AMBULATORY RECORDER

FDA 510(k)

FDA Class 2 ·Neurology

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