LED GOGGLES

FDA 510(k)

FDA Class 2 ·Ophthalmic

ORTHOCOR KNEE SYSTEM BASIC

FDA 510(k)

FDA Class 2 ·Physical Medicine

MODIFICATION TO EDI VERIS SYSTEM

FDA 510(k)

FDA Class 2 ·Ophthalmic

EDI VERIS SYSTEM

FDA 510(k)

FDA Class 2 ·Ophthalmic

PULSAR EM

FDA 510(k)

FDA Class 2 ·Physical Medicine

DOWNING SPECTRAL ILLUMINATOR

FDA 510(k)

FDA Class 2 ·Ophthalmic

BLX WB Ø5.0 (L18), Ø5.5 and Ø6.5 mm (L14 and L16) Implants

FDA 510(k)

FDA Class 2 ·Dental

IceCap product line

FDA 510(k)

FDA Class 2 ·Neurology

Inclusive® Titanium Abutments compatible with: Keystone® Dental PrimaConnex®, Neodent® GM, Straumann® BLX, Implant Direct® Legacy®, Implant Direct® InterActive®, Implant Direct® RePlant® Implant Systems

FDA 510(k)

FDA Class 2 ·Dental

EUROPA™ Navigated Instruments

FDA 510(k)

FDA Class 2 ·Neurology

DiLumen Endolumenal Interventional Scissors (DiLumen Is)

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

LEVITRONIX CENTRIMAG PRIMARY CONSOLE, THORATEC CENTRIMAG PRIMARY CONSOLE

FDA 510(k)

FDA Class 2 ·Cardiovascular

GLUCOMMANDER PLUS

FDA 510(k)

FDA Class 2 ·Anesthesiology

DiLumen Endolumenal Interventional Platform

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

Ellusa Bipolar Wands

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

Coconu Water Based Personal Lubricant

FDA 510(k)

FDA Class 2 ·Obstetrics/Gynecology

SOLITAIRE-C CERVICAL SPACER SYSTEM

FDA 510(k)

FDA Class 2 ·Orthopedic

TEMPUS(TM) CERVICAL PLATE SYSTEM

FDA 510(k)

FDA Class 2 ·Orthopedic

OARtrac System

FDA 510(k)

FDA Class 2 ·Radiology

EffortMed Spinal Fixation System

FDA 510(k)

FDA Class 2 ·Orthopedic