Bone Sonometer

FDA Pre-Market Approval

FDA Class 2 ·ACHILLES EXPRESS ULTRASONOMETER

Bone Sonometer

FDA Pre-Market Approval

FDA Class 2 ·ACHILLES EXPRESS ULTRASONOMETER

BBX-PET Scanner

FDA 510(k)

FDA Class 2 ·Radiology

PALMAZ BLUE .014 TRANSHEPATIC BILIARY STENT SYSTEM-MODEL PB1550,BAS,BAX,PB1560,BAS,BAX,PB1850,BAS,BAXPB1860BAS,BAX

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

BOX DICOM Viewer

FDA 510(k)

FDA Class 2 ·Radiology

Stowe Pedicle Screw System

FDA 510(k)

FDA Class 2 ·Orthopedic

FUSE Pedicle Screw System

FDA 510(k)

FDA Class 2 ·Orthopedic

MED-TEC (MEDICAL INTELLIGENCE) BODYFIX SYSTEM, MODEL MT-BFX

FDA 510(k)

FDA Class 2 ·Radiology

RASTIX X-RAY TABLE

FDA 510(k)

FDA Class 2 ·Radiology

HIMOBILIX 2N

FDA 510(k)

FDA Class 2 ·Radiology

Pedicle Screw System

FDA 510(k)

FDA Class 2 ·Orthopedic

UNDISTAT WITH EXPLORATOR 35 (UCS 35E)

FDA 510(k)

FDA Class 2 ·Radiology

CATAPULT BUCKY (KATAPULT BLENDA)

FDA 510(k)

FDA Class 2 ·Radiology

TELESTATIX X-RAY TABLE

FDA 510(k)

FDA Class 2 ·Radiology

PEDS WATER FILLED CATHETER/TRANSDUCER SYSTEM

FDA 510(k)

FDA Class 2 ·Anesthesiology

THE OPTIC BOX CONTACT LENS CASE

FDA 510(k)

FDA Class 2 ·Ophthalmic

SYMBIOSIS MONOPOLAR ELECTROSURGICAL ROLLER ELECTRODES

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

QUANTA LITE ACA IGM (HRP)

FDA 510(k)

FDA Class 2 ·Immunology

SYMBIOSIS MONOPLAR ELECTROSURGICAL ELECTRODES

FDA 510(k)

FDA Class 2 ·Obstetrics/Gynecology

Wrist Digital Blood Pressure Monitor (BSX312, BSX313, BSX315, BSX322, BSX323, BSX353, BSX355)

FDA 510(k)

FDA Class 2 ·Cardiovascular