MEDIGARD BLOOD COLLECTION DEVICE

FDA 510(k)

FDA Class 2 ·General Hospital

ORTHOPEDIC FIXATION SYSTEMS

FDA 510(k)

FDA Class 2 ·Orthopedic

Implantable Cardioverter Defibrillator (Non-Crt)

FDA Pre-Market Approval

FDA Class 3 ·VARIOUS FAMILIES OF PULSE GENERATORS AND ACCESSORIES

Permanent Defibrillator Electrodes

FDA Pre-Market Approval

FDA Class 3 ·RELIANCE 4-SITE LEADS

Stimulator, Spinal-Cord, Totally Implanted For Pain Relief

FDA Pre-Market Approval

FDA Class 3 ·MEDTRONIC ITREL SPINAL CORD STIMULATION SYSTEM

Acid, Hyaluronic, Intraarticular

FDA Pre-Market Approval

FDA Class 3 ·HYALGAN

Implantable Cardioverter Defibrillator (Non-Crt)

FDA Pre-Market Approval

FDA Class 3 ·ENDOTAK: DSP, ENDURANCE EZ, AND ENDURANCE RX LEADS

Catheter, Percutaneous, Cardiac Ablation, For Treatment Of Atrial Flutter

FDA Pre-Market Approval

FDA Class 3 ·EZ Steer Navigational 4mm; C3 EZ Steer Thermocool Nav; Ez Steer Thermocool Non-Navigational 4mm (TC); EZ Steer Thermocoo

Implantable Pacemaker Pulse-Generator

FDA Pre-Market Approval

FDA Class 3 ·THINLINE ENDOCARDIAL PACING LEADS

Cardiac Ablation Percutaneous Catheter

FDA Pre-Market Approval

FDA Class 3 ·EZ STEER

Stimulator, Spinal-Cord, Totally Implanted For Pain Relief

FDA Pre-Market Approval

FDA Class 3 ·ITREL(R) 3 SYSTEM

ROLLINS 7 OXYGEN MASK

FDA 510(k)

FDA Class 2 ·Anesthesiology

OSTOM-I ALERT

FDA 510(k)

FDA Class 1 ·Gastroenterology, Urology

NODECREST TRANSCRANICAL DOPPLER ULTRASOUND SYSTEM

FDA 510(k)

FDA Class 2 ·Radiology

AUGEASE VASCULAR AUGMENTATION DEVICE

FDA 510(k)

FDA Class 2 ·Cardiovascular

ROYAL SHIELD NON-STERILE BUBBLE GUM SCENTED POWDER-FREE LATEX EXAMINATION GLOVE WITH PROTEIN CONTENT LABELING CLAIM (5O

FDA 510(k)

FDA Class 1 ·General Hospital

HEAT STACK

FDA 510(k)

FDA Class 2 ·General Hospital

AMBIDERM LATEX EXAMINATION GLOVES (VIOLET, BLUE , GREEN, AND PINK) CONTAINING 50 MCGM OR LESS OF TOTAL WATER EXTRACTABLE

FDA 510(k)

FDA Class 1 ·General Hospital

HEATED HUMIDIFIER

FDA 510(k)

FDA Class 2 ·Anesthesiology

TOPOGRAPHIC IMAGING MARKER

FDA 510(k)

FDA Class 2 ·Radiology