TRANS1 TRANS-SACRAL SPINAL ACCESS AND PREPARATION KIT

FDA 510(k)

FDA Class 2 ·Orthopedic

MODIFICATION TO NITREX NITINOL GUIDEWIRE

FDA 510(k)

FDA Class 2 ·Cardiovascular

MODIFICATION TO AQUADEX FLEXFLOW SYSTEM

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

CLOT 2 SEMIAUTOMATIC COAGULATION ANALYZER

FDA 510(k)

FDA Class 2 ·Hematology

ACOUSTIC APPRAISER CD-2 AUDIOMETER/MASTER HEAR.AID

FDA 510(k)

FDA Class 2 ·Ear, Nose, Throat

POWERCHARGER

FDA 510(k)

FDA Class 2 ·Cardiovascular

CIDBA CORNING ACS CORTISOL IMMUNOASSAY

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

QUANTEX D-DIMER

FDA 510(k)

FDA Class 2 ·Hematology

ACL TOP MODEL, TOP

FDA 510(k)

FDA Class 2 ·Hematology

OBSIDIO™ Conformable Embolic

FDA 510(k)

FDA Class 2 ·Cardiovascular

SODEM HIGH SPEED SYSTEM FOR NEUROSURGERY & MEDIAN STERNOTOMY

FDA 510(k)

FDA Class 2 ·Neurology

SENTINOL NITINOL BILLARY STENT SYSTEM

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

CHANNEL BALLOON CATHETER

FDA 510(k)

FDA Class 2 ·Cardiovascular

RADIUS PTCA GUIDEWIRE

FDA 510(k)

FDA Class 2 ·Cardiovascular

MODIFICATION TO ISOLA SPINAL SYSTEM

FDA 510(k)

FDA Class 2 ·Orthopedic

DOVER SILVER TEMPERATURE SENSING FOLEY CATHETER

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

VIEWFLEX PLUS ICE CATHETER

FDA 510(k)

FDA Class 2 ·Cardiovascular

MODIFICATION TO: ATTAIN PREVAIL 6228CTH80 STEERABLE CATHETER SET

FDA 510(k)

FDA Class 2 ·Cardiovascular

EVA DIGITAL DENTAL X-RAY SYSTEM

FDA 510(k)

FDA Class 2 ·Dental

CONTOUR TECHNOLOGY MUSCLE STIMULATOR

FDA 510(k)

FDA Class 2 ·Physical Medicine