PROVEN STEM EXTENDER

FDA 510(k)

FDA Class 2 ·Orthopedic

HUMAN BETA-2 MICROGLOBULIN KIT

FDA 510(k)

FDA Class 2 ·Immunology

SOLUTION ADMINI. SETS- ALTER. DRIP CHAMBER/CONNEC.

FDA 510(k)

FDA Class 2 ·General Hospital

I_OPEN 0.4T

FDA 510(k)

FDA Class 2 ·Radiology

REVERE 6.35 STABILIZATION SYSTEM

FDA 510(k)

FDA Class 2 ·Orthopedic

GEM PREMIER 4000 WITH IQM (ADDITION OF TOTAL BILIRUBIN PARAMETER), GEM CVP 2 (ADDITION OF TOTAL BILIRUBIM ASSIGNMENT TO

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

GELWEAVE BRANCHED VASCULAR GRAFTS WITH RADIOPAQUE MARKERS

FDA 510(k)

FDA Class 2 ·Cardiovascular

POLARIS SPINAL SYSTEM, POLARIS/SYNERGY STRUCTURE ANTERIOR FIXATION SYSTEM

FDA 510(k)

FDA Class 2 ·Orthopedic

CANADY PLASMA ELECTROSURGICAL UNIT SERIES WITH ACCESSORY PROBES AND BLADES

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

Leksell Gamma Knife® (Elekta Esprit); Leksell Gamma Knife® (Icon™); Leksell Gamma Knife® (Perfexion™)

FDA 510(k)

FDA Class 2 ·Radiology

MONET ACQUISITION SYSTEM FOR EEG AND POLYSOMNOGRAPHY

FDA 510(k)

FDA Class 2 ·Neurology

RELY TAMPON

FDA 510(k)

FDA Class 2 ·Obstetrics/Gynecology

DIGITAL THERMOMETER, MODELS BT-A11CN, BT-A21CN, BT-A41CN

FDA 510(k)

FDA Class 2 ·General Hospital

DIGITAL RADIOGRAPHY

FDA 510(k)

FDA Class 2 ·Radiology

TRANSTEK GLASS BODY ANALYZER; TRANSTEK GLASS BODY ANALYZER; TRANSTEK GLASS BODY ANALYZER;TRANSTEK GLASS BODY ANALYZER

FDA 510(k)

FDA Class 2 ·Cardiovascular

MAGNUM CORE TISSUE BIOPSY NEEDLE MODEL MN1820, RP CUTTING NEEDLE MODEL RP-1820, MCN CORE TISSUE BIOPSY NEEDLE MODEL MCN-

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

ULTRAQUIK PERIPHERAL NERVE BLOCK NEEDLE

FDA 510(k)

FDA Class 2 ·Anesthesiology

ANGIODYNAMICS, INC. VENACURE NEVERTOUCH DIRECT PROCEDURE KIT

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

EMERGE PTCA DILATATION CATHETER (MONORAIL) EMERGE PTCA DILATATION CATHETER (OVER-THE-WIRE)

FDA 510(k)

FDA Class 2 ·Cardiovascular

SIMPLI SIMPLER IMPLANT SYSTEM

FDA 510(k)

FDA Class 2 ·Dental