NANO-CHECK AMI CTNI CARDIAC MARKER TEST

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

EzDent-i / E2 / Prora View / Smart M Viewer (v3.5)

FDA 510(k)

FDA Class 2 ·Radiology

EzDent Web

FDA 510(k)

FDA Class 2 ·Radiology

Blue Eye

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

MODIFICATION TO: ACCUSIGN RC DOA 10 (MET/OPI/COC/THC/PCP/BZO/BAR/MTD/TCA/AMP

FDA 510(k)

FDA Class 2 ·Clinical Toxicology

HKT Anatomical Locking Trauma System

FDA 510(k)

FDA Class 2 ·Orthopedic

ANTHRACIS REAL-TIME PCR ASSAY

FDA 510(k)

FDA Class 2 ·Microbiology

GENESIS II TOTAL KNEE SYSTEM

FDA 510(k)

FDA Class 2 ·Orthopedic

Fixone hybrid knotless anchor

FDA 510(k)

FDA Class 2 ·Orthopedic

Dentis s-Clean Regular Abutment

FDA 510(k)

FDA Class 2 ·Dental

QUASAR Standalone ACIF System

FDA 510(k)

FDA Class 2 ·Orthopedic

Hair Up

FDA 510(k)

FDA Class 2 ·Physical Medicine

SUNGSHIM STERILE SINGLE USE INSULIN SYRINGE

FDA 510(k)

FDA Class 2 ·General Hospital

ACR Screw System

FDA 510(k)

FDA Class 2 ·Dental

ANAX 5.5 SPINAL SYSTEM

FDA 510(k)

FDA Class 2 ·Orthopedic

GDH Professional Blood Glucose Monitoring System and GDH Professional LED Blood Glucose Monitoring System

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

Magicore Narrow System

FDA 510(k)

FDA Class 2 ·Dental

EzDent-i / E2 / Prora View/ Smart M Viewer

FDA 510(k)

FDA Class 2 ·Radiology

Fixone Biocomposite Anchor

FDA 510(k)

FDA Class 2 ·Orthopedic

TIBIAL & PATELLAR COMPONENTS FOR THE PROFIX & GENESIS II TOTAL KNEE SYSTEMS

FDA 510(k)

FDA Class 2 ·Orthopedic