DTX-200 BONE DENSITOMETER

FDA 510(k)

FDA Class 2 ·Radiology

Exablate Prostate System

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

SMART WAVE GS100

FDA 510(k)

FDA Class 2 ·Physical Medicine

MDX 2000, DIGITAL ANALYZER

FDA 510(k)

FDA Class 2 ·Hematology

LBA AFP-L3, AFP-L3 CALIBRATOR SET, AFP-L3 CONTROL SET AND LIBASYS

FDA 510(k)

FDA Class 2 ·Immunology

ECHELON HIGH RESOLUTION FOOT COIL (MR-HRF-150), ECHELON LONG BONE COIL (MR-LBC-150)

FDA 510(k)

FDA Class 2 ·Radiology

Rocket Platinum Cured Cathter

FDA 510(k)

FDA Class 2 ·Cardiovascular

Rocket Indwelling Peritoneal Catheter (IPC) Insertion Kit

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

Rocket Indwelling Pleural Catheter (IPC) Insertion Kit

FDA 510(k)

FDA Class 2 ·Cardiovascular

CERVINEEDLE DISPOSABLE CARTRIDGE SYRINGE

FDA 510(k)

FDA Class 2 ·Obstetrics/Gynecology

Rapid Barostat Bag (RBB) Pump and Catheter

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

TAMTEC-HANA TENS / EMS (Sport Muscle Stimulator)

FDA 510(k)

FDA Class 2 ·Physical Medicine

SilverCoat Silicone Foley Catheter

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

ROCKET IPC INSERTION PACK, ROCKET IPC MINI INSERTION SET, ROCKET IPC DRESSING PACK AND BOTTLE SET, ROCKET IPC DRAINAGE B

FDA 510(k)

FDA Class 2 ·Cardiovascular

SPHINCTER OF ODDI MANOMETRIC (SOM) SYSTEM

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

PatCom Distal Chip Endoscope

FDA 510(k)

FDA Class 2 ·Ear, Nose, Throat

Garment Electrodes

FDA 510(k)

FDA Class 2 ·Neurology

Conductive Gel

FDA 510(k)

FDA Class 2 ·Neurology

Rocket IPC Insertion Set, Rocket IPC Mini Insertion Set

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

EMBRYON ULTRASOUND NEEDLE GUIDE

FDA 510(k)

FDA Class 2 ·Obstetrics/Gynecology