SECURE-WRAP (TM) STERILIZATION WRAP

FDA 510(k)

FDA Class 2 ·General Hospital

KOOL GARD SINGLES GOWN

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

DISPOSABLE O.R. TOWEL

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

FLUID REISISTANT EYESHIELD MASK

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

PARA CHECK (AKA EIGHT CHECK-C)

FDA 510(k)

FDA Class 2 ·Hematology

HealthBeacon HB2 Sharps Bin

FDA 510(k)

FDA Class 2 ·General Hospital

BEAMVIEW & BEAMVIEW PLUS (AKA PROJECT 743)

FDA 510(k)

FDA Class 2 ·Radiology

CANDELA SCLERO LONG PULSE LASER (AKA VBEAM)

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

MAXFRAME Multi-Axial Correction System (aka MAXFRAME)

FDA 510(k)

FDA Class 2 ·Orthopedic

Inspire ICE aka Inspire ICE Clear Brackets

FDA 510(k)

FDA Class 2 ·Dental

Flyte Mechanotherapy System (aka Flyte System) (MTI-1.0)

FDA 510(k)

FDA Class 2 ·Obstetrics/Gynecology

INOGEN AT HOME OXYGEN CONCENTRATOR (AKA INOGEN AT HOME)

FDA 510(k)

FDA Class 2 ·Anesthesiology

COBALT MV WITH GENTAMICIN (AKA COBALT G-MV) BONE CEMENT

FDA 510(k)

FDA Class 2 ·Orthopedic

THE DIVACUP MENSTRUAL SOLUTION

FDA 510(k)

FDA Class 2 ·Obstetrics/Gynecology

ClearPath Disposable Introducer

FDA 510(k)

FDA Class 2 ·Neurology

SMPLE PLATE AND SCREWS

FDA 510(k)

FDA Class 2 ·Orthopedic

POLARIS SPINAL SYSTEM, POLARIS/SYNERGY STRUCTUE ANTERIOR FIXATION SYSTEM

FDA 510(k)

FDA Class 2 ·Orthopedic

BIOMET FORERUNNER LOCKING PLATE SYSTEM

FDA 510(k)

FDA Class 2 ·Orthopedic

MAC MALE ADAPTER

FDA 510(k)

FDA Class 2 ·Orthopedic

BIOMET GRAFT DELIVERY SYRINGES

FDA 510(k)

FDA Class 2 ·General Hospital