RESORB-X RESORBABLE PLATING SYSTEM

FDA 510(k)

FDA Class 2 ·Dental

VELOPEX AQUACUT FLUID ABRASION UNIT

FDA 510(k)

FDA Class 2 ·Dental

CONFEES(R)+ CONTACT LENS HOLDER

FDA 510(k)

FDA Class 2 ·Ophthalmic

DIAMEDIX IS-ANTI-GLIADIN IGA TEST SYSTEM

FDA 510(k)

FDA Class 2 ·Immunology

POLYPROPILENE SURGICAL SUTURES

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

DORO RADIOLUCENT HEADREST SYSTEM ( ALSO MRI-COMPATIBLE) AND COMPONENTS

FDA 510(k)

FDA Class 2 ·Neurology

CGA-112 COPING GOLD ALLOY

FDA 510(k)

FDA Class 2 ·Dental

ARTHREX FRACTURE PLATES

FDA 510(k)

FDA Class 2 ·Orthopedic

EXACTECH EQUINOXE R UHMWPE POSTERIOR AUGMENT PEGGED GLENOIDS TM

FDA 510(k)

FDA Class 2 ·Orthopedic

INTRODUCER SETS, MODEL ADELANTE RADIAL

FDA 510(k)

FDA Class 2 ·Cardiovascular

Bovie J-Plasma Precise Open handpiece & Bovie Ultimate Gen 2 High Frequency Electrosurgical Generator

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

STERI-SPOUTS; BAG-SPOUT, VIAL-SPOUT, TRANSFER MIXER; RAPIDFLOW, VIALFLOW, TRANSFLOW

FDA 510(k)

FDA Class 2 ·General Hospital

CORDIS DISPOSABLE ICP PRESSURE TRANSDUCER

FDA 510(k)

FDA Class 2 ·Neurology

2-Way 100% Silicone Cleartract Catheter

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

Neocis Guidance System

FDA 510(k)

FDA Class 2 ·Dental

ZEN WIRELESS FOOTSWITCH (W1000), ZEN WIRELESS FOOTSWITCH ADAPTER (W1100)

FDA 510(k)

FDA Class 2 ·Orthopedic

POWERPLAY MUSCLE MASSAGER

FDA 510(k)

FDA Class 2 ·Physical Medicine

ESOFLIP BALLOON DILATION CATHETER

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

OMNI III PATIENT MONITOR

FDA 510(k)

FDA Class 2 ·Cardiovascular

COULTER STKS WITH RETICULOCYTE ANALYSIS CAPABILITY

FDA 510(k)

FDA Class 2 ·Hematology