Pirouette High Pressure (HP)

FDA 510(k)

FDA Class 2 ·Cardiovascular

NT4-PLUS

FDA 510(k)

FDA Class 2 ·Physical Medicine

VELYS Robotic-Assisted Solution

FDA 510(k)

FDA Class 2 ·Neurology

Sublime Radial Access 018 RX Dilatation Catheter

FDA 510(k)

FDA Class 2 ·Cardiovascular

EmboTrap ll Revascularization Device

FDA 510(k)

FDA Class 2 ·Cardiovascular

EsoFLIP® ES-310 Balloon Catheter

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

Halo One Thin-Walled Guiding Sheath

FDA 510(k)

FDA Class 2 ·Cardiovascular

ATTUNE Total Knee System, ATTUNE Cementless Knee System, LPS Limb Preservation System, Sigma High Performance (HP) Partial Knee System

FDA 510(k)

FDA Class 2 ·Orthopedic

ALKALINE PHOSPHATASE KIT

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

VICTORY GUIDEWIRE (32 MODELS)

FDA 510(k)

FDA Class 2 ·Cardiovascular

IGG IMMUNOTURBIDIMETRIC & CALIBRATOR

FDA 510(k)

FDA Class 2 ·Immunology

ATTUNE® Revision Cones

FDA 510(k)

FDA Class 2 ·Orthopedic

C-REACTIVE PROTEIN IMMUNOTURBIDIMETRIC KIT & CRP CALIBRATOR

FDA 510(k)

FDA Class 2 ·Immunology

DEPUY GLOBAL UNITE SHOULDER SYSTEM

FDA 510(k)

FDA Class 2 ·Orthopedic

CK-MB (NAC-ACT)

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

GI Genius

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

Aerogen®Solo Nebulizer System

FDA 510(k)

FDA Class 2 ·Anesthesiology

Mobility+ Enteral Feeding System OTC

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

BIPAP FOCUS

FDA 510(k)

FDA Class 2 ·Anesthesiology

Sentry IVC Filter

FDA 510(k)

FDA Class 2 ·Cardiovascular