NEEDLEPOINT GUARD

FDA 510(k)

FDA Class 2 ·General Hospital

KIMSTIM AURICULAR ELECTRODE

FDA 510(k)

FDA Class 2 ·Neurology

Brainance MD

FDA 510(k)

FDA Class 2 ·Radiology

Advantis Platform

FDA 510(k)

FDA Class 2 ·Radiology

ALLURA XPER FD SERIES / ALLURA XPER OR TABLE SERIES

FDA 510(k)

FDA Class 2 ·Radiology

ROCC Console

FDA 510(k)

FDA Class 2 ·Radiology

SmartTarget

FDA 510(k)

FDA Class 2 ·Radiology

CentroVena Central Venous Catheter (CVC) with the CentroVena One Insertion System

FDA 510(k)

FDA Class 2 ·General Hospital

Assay, Hybridization And/Or Nucleic Acid Amplification For Detection Of Hepatitis C Rna,Hepatitis C Virus

FDA Pre-Market Approval

FDA Class 2 ·ABBOTT REALTIME HCV, ABBOTT REALTIME HCV AMPLIFICATION REAGENT KIT, ABBOTT REALTIME HVC CONTROL KIT, ABBOTT REALTIME HCV

Assay, Hybridization And/Or Nucleic Acid Amplification For Detection Of Hepatitis C Rna,Hepatitis C Virus

FDA Pre-Market Approval

FDA Class 2 ·ABBOTT REALTIME HCV, ABBOTT REALTIME HCV AMPLIFICATION REAGENT KIT, ABBOTT REALTIME HVC CONTROL KIT, ABBOTT REALTIME HCV

Assay, Hybridization And/Or Nucleic Acid Amplification For Detection Of Hepatitis C Rna,Hepatitis C Virus

FDA Pre-Market Approval

FDA Class 2 ·ABBOTT REALTIME HCV, ABBOTT REALTIME HCV AMPLIFICATION REAGENT KIT, ABBOTT REALTIME HVC CONTROL KIT, ABBOTT REALTIME HCV

Advanced Diffusion Analysis (ADA) application

FDA 510(k)

FDA Class 2 ·Radiology

Longitudinal Brain Imaging (LoBI) application

FDA 510(k)

FDA Class 2 ·Radiology

ALLURA XPER FD10

FDA 510(k)

FDA Class 2 ·Radiology

Multi-Modality Tumor Tracking (MMTT) application

FDA 510(k)

FDA Class 2 ·Radiology

The Multimodality Advanced Vessel Analysis

FDA 510(k)

FDA Class 2 ·Radiology

KODEX EPD System

FDA 510(k)

FDA Class 2 ·Cardiovascular

APACERAM OSSICULAR PROSTHESIS

FDA 510(k)

FDA Class 2 ·Ear, Nose, Throat

APACERAM HYDROXYLAPATITE DENTAL IMPLANT (TYPE G)

FDA 510(k)

FDA Class 2 ·Dental

APACERAM ARTIFICIAL DENTAL IMPLANT

FDA 510(k)

FDA Class 2 ·Dental