HEMODIALYSIS SYSTEM

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

CAPI 3 Hb A1c

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

MICROTARGETING ELECTRODE

FDA 510(k)

FDA Class 2 ·Neurology

MICROTARGETING STAR DRIVE SYSTEM, COMPONENTS

FDA 510(k)

FDA Class 2 ·Neurology

STarFix Designer Software C0265

FDA 510(k)

FDA Class 2 ·Neurology

MICRO TARGETING ELECTRODE

FDA 510(k)

FDA Class 2 ·Neurology

MICROTARGETING DRIVE SYSTEM

FDA 510(k)

FDA Class 2 ·Neurology

WAYPOINT STEREOTACTIC SYSTEM

FDA 510(k)

FDA Class 2 ·Neurology

microTargeting Guideline 4000 5.0 System

FDA 510(k)

FDA Class 2 ·Neurology

FHC MICROTARGETING DRIVE SYSTEM

FDA 510(k)

FDA Class 2 ·Neurology

MICROTARGETING GUIDELINE 4000

FDA 510(k)

FDA Class 2 ·Neurology

MICRO TARGETING DRIVE SYSTEM

FDA 510(k)

FDA Class 2 ·Neurology

MICROTARGETING XL STAR DRIVE SYSTEM

FDA 510(k)

FDA Class 2 ·Neurology

VFS1 Bipolar Electrosurgical Generator

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

RESUBMITTED ABBOTT LIFECARE MODEL 3 HB PUMP

FDA 510(k)

FDA Class 2 ·General Hospital

ZSFab Lumbar Interbody System

FDA 510(k)

FDA Class 2 ·Orthopedic

CAPI 3 Hb A1c, MULTI-SYSTEM Hb A1C CAPILLARY CONTROLS (2)

FDA 510(k)

FDA Class 2 ·Hematology

System, Test, Carcinoembryonic Antigen

FDA Pre-Market Approval

FDA Class 2 ·TANDEM(R) E CEA IMMUNORADIOMETRIC ASSAY

BABY DOPPLEX 4000 (BD4000)

FDA 510(k)

FDA Class 2 ·Obstetrics/Gynecology

GranOSTM - beta tricalcium phosphate synthetic bone granules

FDA 510(k)

FDA Class 2 ·Orthopedic