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

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

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

MEDISIGN BLOOD GLUCOSE MONITORING SYSTEM

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

BOOMERANG ABSORPTION COMENSATION FILTER

FDA 510(k)

FDA Class 2 ·Radiology

AUTOMOATIC BLOOD PRESSURE MONITOR, MODELS: EASY X 800 AND 900 (R/L)

FDA 510(k)

FDA Class 2 ·Cardiovascular

Needle, Phacoemulsification, Reprocessed

FDA classification

FDA Class 2 ·Needle, Phacoemulsification, Reprocessed

Media, Reproductive, Exempt

FDA classification

FDA Class 2 ·Media, Reproductive, Exempt

Lens, Contact (Other Material) - Daily

FDA Pre-Market Approval

FDA Class 2 ·FLUOROPERM (PAFLUFOCON A) RGP CONTACT LENS