OXY-TWO

FDA 510(k)

FDA Class 1 ·Anesthesiology

Neonav ECG Tip Location System

FDA 510(k)

FDA Class 2 ·General Hospital

Origin™ TT Stem

FDA 510(k)

FDA Class 2 ·Orthopedic

O'NEIL STERILE FIELD INTERMITTENT URINARY CATHETER

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

World Knee System

FDA 510(k)

FDA Class 2 ·Orthopedic

InsufflatOR Needle

FDA 510(k)

FDA Class 2 ·Obstetrics/Gynecology

Annalise Enterprise CXR Triage Trauma

FDA 510(k)

FDA Class 2 ·Radiology

FerriSmart Analysis System

FDA 510(k)

FDA Class 2 ·Radiology

PEEK RCI Screw; Bio-Composite Screw; SignaLoc Screw

FDA 510(k)

FDA Class 2 ·Orthopedic

L D H-L (LACTIC DEHYDROGENASE) REAGENT

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

COOK Sydney IVF Blastocyst Vitrification Kit, COOK Sydney IVF Blastocyst Warming Kit

FDA 510(k)

FDA Class 2 ·Obstetrics/Gynecology

PORTABLE LIMB LOAD MONITOR (BMLLM-100)

FDA 510(k)

FDA Class 1 ·Physical Medicine

MARK II CO2 FLUSH MANOMETRIC PERFUSION PUMP & MARK II MANOMETRIC PERFUSION PUMP

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

World Liner

FDA 510(k)

FDA Class 2 ·Orthopedic

TLC Unicompartmental Knee System

FDA 510(k)

FDA Class 2 ·Orthopedic

AirPhysio Positive Expiratory Pressure (PEP) Device

FDA 510(k)

FDA Class 2 ·Anesthesiology

CardioCel 3D

FDA 510(k)

FDA Class 2 ·Cardiovascular

Menai System

FDA 510(k)

FDA Class 2 ·Anesthesiology

World Total Knee System

FDA 510(k)

FDA Class 2 ·Orthopedic

Striate+™

FDA 510(k)

FDA Class 2 ·Dental