Activ Fuse

FDA 510(k)

FDA Class 2 ·Orthopedic

Cyware 4H and Cysart 4H

FDA 510(k)

FDA Class 2 ·Radiology

Nutricair Enteral Syringe with ENFit

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

SUBFIX ARTHROEREISIS IMPLANT, MODELS SUT0065, SUT0080, SUT0090, SUT0100, SUT0115

FDA 510(k)

FDA Class 2 ·Orthopedic

QUANTUM® Patient Specific Instrumentation (PSI) System

FDA 510(k)

FDA Class 2 ·Orthopedic

VISTA PLUS

FDA 510(k)

FDA Class 2 ·Cardiovascular

KODAK 9000, KODAK 9000 3D

FDA 510(k)

FDA Class 2 ·Dental

MICROS 60

FDA 510(k)

FDA Class 2 ·Hematology

GENERAL CHEMISTRIES ON ABX PENTRA 400 CLINICAL CHEMISTRY ANALYZER

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

CHROMID CARBA agar (CARB)

FDA 510(k)

FDA Class 2 ·Microbiology

Sim&Size

FDA 510(k)

FDA Class 2 ·Radiology

BLUEPRINT™ Patient Specific Instrumentation

FDA 510(k)

FDA Class 2 ·Orthopedic

ART-Plan+ (v.3.0.0)

FDA 510(k)

FDA Class 2 ·Radiology

ETEST Imipenem/Relebactam P. aeruginosa (IRPA) (0.008/4-128/4 µg/mL)

FDA 510(k)

FDA Class 2 ·Microbiology

DUTAU-NOVATECH®

FDA 510(k)

FDA Class 2 ·Ear, Nose, Throat

AEQUALIS SHOULDER SYSTEM

FDA 510(k)

FDA Class 2 ·Orthopedic

S-357 VIDEO IMAGING SYSTEM

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

Embosphere Microspheres

FDA 510(k)

FDA Class 2 ·Cardiovascular

Cellvizio I.V.E. system with Confocal Miniprobes

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

PULLUP BTB Adjustable Fixation System for Ligament Reconstruction, PULLUP CLIP Adjustable Fixation System for Ligament Reconstruction, PULLUP TEX CLIP Adjustable Fixation System for Ligament Reconstruction, BT LOOP Adjustable Fixation System for Ligament Reconstruction

FDA 510(k)

FDA Class 2 ·Orthopedic