Sharps Needle Destruction Device

FDA Pre-Market Approval

FDA Class 2 ·DISINTEGRATOR PRO NEEDLE DESTRUCTION DEVICE

Lung Nodule Assessment and Comparison Option (LNA)

FDA 510(k)

FDA Class 2 ·Radiology

Test, Alpha Fetoprotein L3 Subfraction (Afp-L3%), For Hepatocellular Carcinoma Risk Assessment

FDA classification

FDA Class 2 ·Test, Alpha Fetoprotein L3 Subfraction (Afp-L3%), For Hepatocellular Carcinoma Risk Assessment

CAREO SAFETY SYRINGE 1CC/ML, MODELS CA0106-C,CA0196-C,CA0186-C,CA0107-C,CA0197-C,CA0187-C,CA0104-C,CA0194-C,CA0184-C,

FDA 510(k)

FDA Class 2 ·General Hospital

Access PCT

FDA 510(k)

FDA Class 2 ·Microbiology

Diazyme Procalcitonin (PCT) Assay, Diazyme Procalcitonin (PCT) Calibrator Set, Diazyme Procalcitonin (PCT) Control Set

FDA 510(k)

FDA Class 2 ·Microbiology

DiaSys Procalcitonin FS; DiaSys TruCal Procalcitonin Calibrator Set; DiaSys TruLab Procalcitonin Bi-Level Controls

FDA 510(k)

FDA Class 2 ·Microbiology

Access PCT, Access PCT Calibrators

FDA 510(k)

FDA Class 2 ·Microbiology

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

FDA 510(k)

FDA Class 2 ·Cardiovascular

XPERCT REL. 3

FDA 510(k)

FDA Class 2 ·Radiology

Ingenia Elition and MR 7700 MR Systems

FDA 510(k)

FDA Class 2 ·Radiology

Philips IntelliSite Pathology Solution 5.1

FDA 510(k)

FDA Class 2 ·Pathology

Brain Perfusion (BP) application

FDA 510(k)

FDA Class 2 ·Radiology

EXSUDEX WOUND DRAINAGE PUMP

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

16 Breast Coil

FDA 510(k)

FDA Class 2 ·Radiology

Philips IntelliSite Pathology Solution

FDA 510(k)

FDA Class 2 ·Pathology

Ingenia 1.5T CX and Ingenia 3.0T CX R5.3

FDA 510(k)

FDA Class 2 ·Radiology

Philips IntelliSite Pathology Solution

FDA 510(k)

FDA Class 2 ·Pathology

Brain Perfusion (BP) application

FDA 510(k)

FDA Class 2 ·Radiology

MR 5300 and MR 7700 R11 MR Systems

FDA 510(k)

FDA Class 2 ·Radiology