AUTOMATES COMA PLUS COCAINE METABOLITE ASSAY

FDA 510(k)

FDA Class 2 ·Clinical Toxicology

AUTOMATES COMA COCAINE METABOLITE ASSAY

FDA 510(k)

FDA Class 2 ·Clinical Toxicology

Embosphere Microspheres

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

Full Field Digital, System, X-Ray, Mammographic

FDA Pre-Market Approval

FDA Class 2 ·SIEMENS MAMMOMAT NOVATION FULL-FIELD DIGITAL MAMMOGRAPHY (FFDM) SYSTEM

VPOD ITPR

FDA 510(k)

FDA Class 2 ·Anesthesiology

TorqVue Low Profile Delivery Catheter

FDA 510(k)

FDA Class 2 ·Cardiovascular

Sublime Radial Access 018 RX Dilatation Catheter

FDA 510(k)

FDA Class 2 ·Cardiovascular

1788 4K Camera System with Advanced Imaging Modality; L12 LED Light Source with AIM

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

780 nm L11 LED Light Source with AIM

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

Stryker AIM Light Source and SafeLight cable

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

Stryker Infrared Fluorescence (IRF) Imaging System

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

CELLVIZIO 100 SERIES SYSTEM WITH CONFOCAL MINIPROBES

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

Cellvizio 100 Series System with Confocal Miniprobes

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

Cellvizio 100 Series System with Confocal Miniprobes

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

CELLVIZIO 100 SERIES AND CELLVIZIO SYSTEMS WITH CONFOCAL MINIPROBES

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

Cellvizio I.V.E. with Confocal Miniprobes

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

Visera Elite II Xenon Light Source, Telescope IR/Telescope Ultra, Visera Elite II Video System Center, HD 3CMOS Autoclavable Camera Head, HD 3CMOS Camera Head

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

VS3-IR

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

KARL STORZ ICG Imaging System, KARL STORZ Image1S Camera Control Unit

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

CELLVIZIO 100 SERIES SYSTEM WITH CONFOCAL MINIPROBES (TM)

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology