Sensus IORT System

FDA 510(k)

FDA Class 2 ·Radiology

iTEAR Neurostimulator

FDA 510(k)

FDA Class 2 ·Ophthalmic

Diamondback 360 Peripheral Orbital Atherectomy System, Stealth 360 Peripheral Orbital Atherectomy System

FDA 510(k)

FDA Class 2 ·Cardiovascular

AMNISCREEN HOME DETECTION LINER KIT

FDA 510(k)

FDA Class 1 ·Clinical Chemistry

OMNIGRIP, LATEX SURGICAL GLOVE, POWDER FREE

FDA 510(k)

FDA Class 1 ·General, Plastic Surgery

CLEAR (TM) SPECIAL NIT COMB

FDA 510(k)

FDA Class 1 ·General Hospital

Acumed Small Fragment Base Set

FDA 510(k)

FDA Class 2 ·Orthopedic

ACUMED CONGRUENT BONE PLATE SYSTEM

FDA 510(k)

FDA Class 2 ·Orthopedic

ViperCath XC Peripheral Exchange Catheter

FDA 510(k)

FDA Class 2 ·Cardiovascular

MONOSTAR SYSTEM: IM LATEX TEST

FDA 510(k)

FDA Class 2 ·Immunology

Jade 37% Phosphoric Acid Etchant Gel

FDA 510(k)

FDA Class 2 ·Dental

Sensus Healthcare Superficial X-ray Radiation Therapy System with Ultrasonic Imaging Capabilities

FDA 510(k)

FDA Class 2 ·Radiology

ControlRad Sterile Cover

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

ACUMED LOWER EXTREMITY CONGRUENT PLATE SYSTEM

FDA 510(k)

FDA Class 2 ·Orthopedic

Vyvo

FDA 510(k)

FDA Class 2 ·Cardiovascular

MODIFICATION TO OPTIMUM CLEANING, DISINFECTING AND

FDA 510(k)

FDA Class 2 ·Ophthalmic

Acumed Small Bone IM Nail System

FDA 510(k)

FDA Class 2 ·Orthopedic

WIRION

FDA 510(k)

FDA Class 2 ·Cardiovascular

ACUMED PELVIC BONE PLATE SYSTEM

FDA 510(k)

FDA Class 2 ·Orthopedic

SENSUS HELTHCARE IMAGE-DUIDED SUPERFICIAL RADIOTHERAPY SYSTEM

FDA 510(k)

FDA Class 2 ·Radiology