A-BEC FIREBALL 40

FDA 510(k)

FDA Class 2 ·Physical Medicine

A-BEC 40 POWER WHEELCHAIR

FDA 510(k)

FDA Class 2 ·Physical Medicine

Full Field Digital, System, X-Ray, Mammographic

FDA Pre-Market Approval

FDA Class 2 ·SELENIA FULL FIELD DIGITAL MAMMOGRAPHY SYSTEM

MICROSHEV MODEL 2000

FDA 510(k)

FDA Class 2 ·Neurology

QCS HER2 IMMUNOCONTROLS (PRODUCT NO. C010)

FDA 510(k)

FDA Class 2 ·Hematology

BAYER IMMUNO 1 HER-2/NEU ASSAY

FDA 510(k)

FDA Class 2 ·Immunology

Her-2, ER, PR IHControls

FDA 510(k)

FDA Class 2 ·Hematology

MANUAL HER-2/NEU MICROTITER ELISA (OSDI HER-2/NEU ELISA)

FDA 510(k)

FDA Class 2 ·Immunology

BAYER ADVIA CENTAUR HER-2/NEU ASSAY

FDA 510(k)

FDA Class 2 ·Immunology

Full Field Digital, System, X-Ray, Mammographic

FDA Pre-Market Approval

FDA Class 2 ·HOLOGIC SELENIA DIMENSIONS 2D FULL FIELD DIGITAL MAMMOGRAPHY SYSTEM

X-RAY UNIT, PORTABLE GX-101 AEC

FDA 510(k)

FDA Class 2 ·Radiology

MODIFICATION TO REFLEX AEC LINEAR STAPLER/CUTTER

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

ELECSYS HE4, ELECSYS HE4 CALSET, ELECSYS PRECICONTROL HE4, ELECSYS HE4 CALCHECK 5

FDA 510(k)

FDA Class 2 ·Immunology

ARCHITECT HE4, ARCHITECT HE4 CALIBRATORS AND ARCHITECT HE4 CONTROLS, MODELS 2, 2P54, 2P54-01, 2P54-10 SP54-01,

FDA 510(k)

FDA Class 2 ·Immunology

HE4 EIA, MODEL: 404-10 US

FDA 510(k)

FDA Class 2 ·Immunology

FUJIREBIO DIAGNOSTICS TUMOR MARKER CONTROL

FDA 510(k)

FDA Class 2 ·Immunology

Lumipulse G HE4 Immunoreaction Cartridges, Lumipulse G HE4 Calibrators

FDA 510(k)

FDA Class 2 ·Immunology

MODIFICATION TO PINNACLE CONSTRAINED ACETABULAR LINERS

FDA 510(k)

FDA Class 2 ·Orthopedic

DEPUY PINNACLE ACETABULAR CUP SYSTEM, ESL MARATHON POLYETHYLENE LINERS, AND DEPUY ULTIMA UNIPOLAR FEMORAL HEADS

FDA 510(k)

FDA Class 2 ·Orthopedic

ET US SS Prosthetic system

FDA 510(k)

FDA Class 2 ·Dental