IMPAX CLIENT EMBRACE

FDA 510(k)

FDA Class 2 ·Radiology

LC Bead LUMI

FDA 510(k)

FDA Class 2 ·Cardiovascular

Arc Endocuff Vision

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

M3 MONITOR

FDA 510(k)

FDA Class 2 ·Cardiovascular

Quantum Smart Occluder LH (left-hand), Quantum Smart Occluder LH (right-hand)

FDA 510(k)

FDA Class 2 ·Cardiovascular

Flat Panel Detector

FDA 510(k)

FDA Class 2 ·Radiology

ARC ENDOCUFF

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

Quantum Ventilation Module

FDA 510(k)

FDA Class 2 ·Cardiovascular

Quantum Diagnostic Module, Quantum Diagnostic Module - No Gas

FDA 510(k)

FDA Class 2 ·Cardiovascular

M3 MONITOR

FDA 510(k)

FDA Class 2 ·Cardiovascular

Bead Block

FDA 510(k)

FDA Class 2 ·Cardiovascular

IMPAX OT3000 ORTHOPEDIC WORKSTATION

FDA 510(k)

FDA Class 2 ·Radiology

Bead Block (100 - 300µm, 1ml), Bead Block (300 - 500µm, 1ml), Bead Block (500 - 700µm, 1ml), Bead Block (700 - 900µm, 1ml), Bead Block (900 - 1200µm, 1ml), Bead Block (100 - 300µm, 2ml), Bead Block (300 - 500µm, 2ml), Bead Block (500 - 700µm, 2ml), Bead Block (700 - 900µm, 2ml), Bead Block (900 - 1200µm, 2ml)

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

Quantum Workstation 12.1

FDA 510(k)

FDA Class 2 ·Cardiovascular

Quantum Micro-Cardioplegia Delivery System; Quantum Micro-Cardioplegia Delivery Module (QMCDM)

FDA 510(k)

FDA Class 2 ·Cardiovascular

Quantum Workstation

FDA 510(k)

FDA Class 2 ·Cardiovascular

Quantum Workstation 12 Elite

FDA 510(k)

FDA Class 2 ·Cardiovascular

OXYCON PRO

FDA 510(k)

FDA Class 2 ·Anesthesiology

MODIFICATION TO THE OXYCONALPHA

FDA 510(k)

FDA Class 2 ·Anesthesiology

LumiGuide Wire; LumiGuide Equipment R2.0; LumiGuide 3D Hub

FDA 510(k)

FDA Class 2 ·Cardiovascular