STERITEC SMART-READ BIOLOGICAL TEST PACK WITH INSTANT READOUT INTEGRATOR

FDA 510(k)

FDA Class 2 ·General Hospital

FIREFLY® Midline Navigation Guide

FDA 510(k)

FDA Class 2 ·Orthopedic

IMEX 8000 PERSONAL CASCULAR LAB

FDA 510(k)

FDA Class 2 ·Radiology

SPINEFRONTIER ARENA-C HA PEEK CERVICAL INTERVERTEBRAL BODY FUSION DEVICE

FDA 510(k)

FDA Class 2 ·Orthopedic

MODIFICATION OF PASCO MIC AND MIC/ID PANELS

FDA 510(k)

FDA Class 2 ·Microbiology

ARENA-C TIFUSE CERVICAL INTERVERTEBRAL BODY FUSION DEVICE

FDA 510(k)

FDA Class 2 ·Orthopedic

Viveve 2.0 System

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

Epic Anterior Thoracolumbar Plate System, Gallery Laminoplasty Fixation System, Concero Facet Screw System, Alpine XC Adjustable Fusion System, Aspen MIS Fusion System, L-Plate MIS Fusion System

FDA 510(k)

FDA Class 2 ·Orthopedic

SPECTRANETICS LLD CS, MODEL 518-039

FDA 510(k)

FDA Class 2 ·Cardiovascular

Visualase MRI-Guided Laser Ablation System (SW 3.4)

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

PASCO MIC AND MIC/ID PANELS

FDA 510(k)

FDA Class 2 ·Microbiology

COBE C HEMODIALYSIS DELIVERY SYSTEM , COBE CARTRIDGE BLOOD TUBING SET

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

REAADS IGA ANTI-PHOSPHATIDYLSERINE SEMI-QUANTITATIVE TEST KIT

FDA 510(k)

FDA Class 2 ·Immunology

Avenue P Cage System

FDA 510(k)

FDA Class 2 ·Orthopedic

MIC-BIO-PLATE

FDA 510(k)

FDA Class 2 ·Microbiology

Viveve System, Viveve 2.0 System

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

MCKINLEY SATURATION CATHETER

FDA 510(k)

FDA Class 2 ·General Hospital

ALPINE PORTABLE OXYGEN GENERATOR

FDA 510(k)

FDA Class 2 ·Anesthesiology

PRISMA CFM (CONTINUOUS FLUID MANAGEMENT SYSTEM)

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

RS232 FLOW SENSOR AND SOFTWARE PACKAGE

FDA 510(k)

FDA Class 2 ·Anesthesiology