HMB32 Dialysis Solution

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

Revision Femoral Stem

FDA 510(k)

FDA Class 2 ·Orthopedic

CARDIOLINE touchECG

FDA 510(k)

FDA Class 2 ·Cardiovascular

Physica CR Knee System

FDA 510(k)

FDA Class 2 ·Orthopedic

Physica System (Physica CR Porous Femoral components)

FDA 510(k)

FDA Class 2 ·Orthopedic

SMR 3-Pegs Glenoids

FDA 510(k)

FDA Class 2 ·Orthopedic

SMR Modular Glenoid

FDA 510(k)

FDA Class 2 ·Orthopedic

H-Max S stem

FDA 510(k)

FDA Class 2 ·Orthopedic

TEMA Elbow System

FDA 510(k)

FDA Class 2 ·Orthopedic

SMR TT Metal Back Glenoid, Bone Graft instruments

FDA 510(k)

FDA Class 2 ·Orthopedic

ICOONE h (also referred to as ICOONE LASER and ICOONE –h LASER)

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

C2 femoral stem

FDA 510(k)

FDA Class 2 ·Orthopedic

SMR Lateralized Connectors with screws

FDA 510(k)

FDA Class 2 ·Orthopedic

TOTAL BILIRUBIN L3K, MODEL 295-10 AND 295-30

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

MasterSL femoral stem

FDA 510(k)

FDA Class 2 ·Orthopedic

RESPIFLO

FDA 510(k)

FDA Class 2 ·Anesthesiology

Revision Femoral Stem

FDA 510(k)

FDA Class 2 ·Orthopedic

Physica PS Knee System

FDA 510(k)

FDA Class 2 ·Orthopedic

H-MAX S Femoral Hip System

FDA 510(k)

FDA Class 2 ·Orthopedic

ACETAMINOPHEN L3K ASSAY, AND ACETAMINOPHEN L3K ASSAY, MODELS 506-10, 506-30

FDA 510(k)

FDA Class 2 ·Clinical Toxicology