Intervertebral Fusion Device With Bone Graft, Lumbar

FDA Pre-Market Approval

FDA Class 2 ·BRANTIGEN I/F CAGE(R) USED WITH VSP(R) SPINE PLATES AND PEDICLE SCREWS

Assay, Enzyme Linked Immunosorbent, Hepatitis C Virus

FDA Pre-Market Approval

FDA Class 2 ·ELECSYS ANTI-HCV IMMUNOASSAY & ELECSYS PRECICONTROL ANTI-HCV FOR USE ON COBAS E411

Assay, Enzyme Linked Immunosorbent, Hepatitis C Virus

FDA Pre-Market Approval

FDA Class 2 ·ELECSYS ANTI-HCV IMMUNOASSAY, ELECSYS PRECICONTROL ANTI-HCV FOR USE ON COBAS E411 IMMUNOSSAY ANALYZER

Assay, Enzyme Linked Immunosorbent, Hepatitis C Virus

FDA Pre-Market Approval

FDA Class 2 ·ELECSYS ANTI-HCV IMMUNOASSAY & ELECSYS PRECICONTROL ANTI-HCV FOR USE ON E170 IMMUNOASSAY ANALYZER

Assay, Enzyme Linked Immunosorbent, Hepatitis C Virus

FDA Pre-Market Approval

FDA Class 2 ·ELECSYS ANTI-HCV IMMUNOASSAY, ELECSYS PRECICONTROL ANTI-HCV FOR USE ON COBAS E411 IMMUNOSSAY ANALYZER

GLIADIN ANTIBODIES ELISA

FDA 510(k)

FDA Class 2 ·Immunology

YUKON OCT Spinal System

FDA 510(k)

FDA Class 2 ·Orthopedic

K2M Fenestrated Tap System

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

INNOFLUOR(TM) THEOPHYLLINE CALIBRATOR SET

FDA 510(k)

FDA Class 2 ·Clinical Toxicology

NATURAL BRIDGE LP TRANSVERSE CONNECTORS

FDA 510(k)

FDA Class 2 ·Orthopedic

Body Pro-Lok Respiratory Plate, Respiratory Plate Cushion, Body Pro-Respiratory Belt, Rail Clamp for Respiratory Belt, Pressure Gauge Replacement

FDA 510(k)

FDA Class 2 ·Radiology

CAPRI Corpectomy Cage System

FDA 510(k)

FDA Class 2 ·Orthopedic

AVERA MODEL DEI SYSTEM (DIFFRACTIVE ENERGY IMAGING SYSTEM)

FDA 510(k)

FDA Class 2 ·Radiology

Sensor Medical Single Use Tonometer Prism

FDA 510(k)

FDA Class 2 ·Ophthalmic

AMBULATORY BLOOD PRESSURE (ABP) 92506 REPORT MANAGEMENT SYSTEM (RMS), MODEL 92506

FDA 510(k)

FDA Class 2 ·Cardiovascular

KREATIV MODEL KV-1

FDA 510(k)

FDA Class 2 ·Dental

SONOSITE HIGH-RESOLUTION DIAGNOSTIC ULTRASOUND SYSTEM (C3 SERIES)

FDA 510(k)

FDA Class 2 ·Radiology

PROXIMAL HUMERUS PLATING SYSTEM

FDA 510(k)

FDA Class 2 ·Orthopedic

IDI IMPLANT SYSTEM

FDA 510(k)

FDA Class 2 ·Dental

SonoSite Edge II Ultrasound System

FDA 510(k)

FDA Class 2 ·Radiology