Innova IGS 5, Innova IGS 6, Discovery IGS 7, Discovery IGS 7 OR

FDA 510(k)

FDA Class 2 ·Radiology

Yumizen C1200 Creatinine PAP

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

TORNIER CEMENT RESTRICTOR

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

SALTO TALARIS TOTAL ANKLE PROSTHESIS

FDA 510(k)

FDA Class 2 ·Orthopedic

Aixplorer®MACH20, Aixplorer®MACH30, Supersonic MACH40, Supersonic MACH30 & Supersoinc MACH20 Ultrasonic Diagnostic Systems

FDA 510(k)

FDA Class 2 ·Radiology

JAZZ FRAME SYSTEM

FDA 510(k)

FDA Class 2 ·Orthopedic

TotalC-Ram

FDA 510(k)

FDA Class 2 ·Dental

Yumizen C1200 Immunoglobulin A, Yumizen C1200 Immunoglobulin G, Yumizen C1200 Immunoglobulin M

FDA 510(k)

FDA Class 2 ·Immunology

MINIDEF (OR DEFIPORT

FDA 510(k)

FDA Class 2 ·Cardiovascular

EXPAZEN

FDA 510(k)

FDA Unclassified ·Unknown

AEQUALIS REVERSED SHOULDER PROSTHESIS

FDA 510(k)

FDA Class 2 ·Orthopedic

Cellvizio 100 Series System with Confocal Miniprobes

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

TRACHEOBRONXANE™ DUMON®

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

PULLUP® Adjustable Juxtacortical Fixation Device

FDA 510(k)

FDA Class 2 ·Orthopedic

FastStroke

FDA 510(k)

FDA Class 2 ·Radiology

Idys™ ALIF System

FDA 510(k)

FDA Class 2 ·Orthopedic

SP NEWTRON MODULE

FDA 510(k)

FDA Class 2 ·Dental

FIDIS VASCULITIS ASSAY KIT AND ANALYZER AND CARIS SYSTEM

FDA 510(k)

FDA Class 2 ·Immunology

Alians Elbow Locking Plating System

FDA 510(k)

FDA Class 2 ·Orthopedic

Nexis® compressive screws

FDA 510(k)

FDA Class 2 ·Orthopedic