WATER PURIFICATION SYSTEM FOR HEMODIALYSIS

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

PERIMETER INTERBODY FUSION DEVICE

FDA 510(k)

FDA Class 2 ·Orthopedic

QUESTLOCK ACL FIXATOR

FDA 510(k)

FDA Class 2 ·Orthopedic

Choice Spine Hawkeye™ Vertebral Body Replacement (VBR) System

FDA 510(k)

FDA Class 2 ·Orthopedic

RMC POSTERIOR STABILIZED KNEE SYSTEM

FDA 510(k)

FDA Class 2 ·Orthopedic

P.A. ENTERAL FEEDING BAG 1100

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

Redemption Duo Hindfoot Nail System

FDA 510(k)

FDA Class 2 ·Orthopedic

CD Horizon ModuLeX FNS Screw Set (Fenestrated Screw); CD Horizon ModuLeX Spinal System (Modular Extended Tab Head)

FDA 510(k)

FDA Class 2 ·Orthopedic

SWANSON TITANIUM CONDYLAR IMPLANT

FDA 510(k)

FDA Class 2 ·Orthopedic

CUBESCAN BIOCON-500 DIAGNOSTIC ULTRASOUND SYSTEM

FDA 510(k)

FDA Class 2 ·Radiology

RUSH PIN

FDA 510(k)

FDA Class 2 ·Orthopedic

PRESSSION, SEQUENTIAL

FDA 510(k)

FDA Class 2 ·Cardiovascular

ZIRCONIA CERAMIC HEAD (YITRIA STABILIZED)

FDA 510(k)

FDA Class 2 ·Orthopedic

K-LASER K-1200, MODEL 12 W

FDA 510(k)

FDA Class 2 ·Physical Medicine

REFLECTION, TANDEM UNIPOLAR

FDA 510(k)

FDA Class 2 ·Orthopedic

MODIFICATON TO: PYRAMID +4 ANTERIOR LUMBAR PLATE SYSTEM

FDA 510(k)

FDA Class 2 ·Orthopedic

ELEVATE Spinal System, CAPSTONE PTC Spinal System, CRESCENT Spinal System, CRESCENT Spinal System Titanium

FDA 510(k)

FDA Class 2 ·Orthopedic

COMPACT COTREL-DUBOUSSET (CCD) SPINAL SYSTEM

FDA 510(k)

FDA Class 2 ·Orthopedic

DragonFly Surgical Drill System

FDA 510(k)

FDA Class 2 ·Ear, Nose, Throat

PIGALILEO 4TH GENERATION SYSTEM

FDA 510(k)

FDA Class 2 ·Neurology