GXR-Series Diagnostic X-Ray System

FDA 510(k)

FDA Class 2 ·Radiology

KJ Mini Implant System

FDA 510(k)

FDA Class 2 ·Dental

EDEN Spinal Fixation System

FDA 510(k)

FDA Class 2 ·Orthopedic

DIAMOND-5A/6A/8A

FDA 510(k)

FDA Class 2 ·Radiology

PICA WHOLE-BODY MRI SYSTEM

FDA 510(k)

FDA Class 2 ·Radiology

INFLUENZA A/H5 (ASIAN LINEAGE) VIRUS REAL-TIME RT-PCR PRIMER AND PROBE SET

FDA 510(k)

FDA Class 2 ·Microbiology

Non-variola Orthopoxvirus Real-time PCR Primer and Probe Set

FDA 510(k)

FDA Class 2 ·Microbiology

Non-variola Orthopoxvirus Real-time PCR Primer and Probe Set

FDA 510(k)

FDA Class 2 ·Microbiology

SONOACE 4500 DIAGNOSTIC ULTRASOUND IMAGING SYSTEM

FDA 510(k)

FDA Class 2 ·Radiology

B. anthracis Real-time PCR Assay

FDA 510(k)

FDA Class 2 ·Microbiology

HS40 Diagnostic Ultrasound System

FDA 510(k)

FDA Class 2 ·Radiology

CDC HUMAN INFLUENZA VIRUS REAL-TIME RT-PCR DIAGNOSTIC PANEL

FDA 510(k)

FDA Class 2 ·Microbiology

Catheters, Transluminal Coronary Angioplasty, Percutaneous

FDA Pre-Market Approval

FDA Class 2 ·ACS RX COMET CORONARY DILATION CATHETER

MEDCYC SUPERCONDUCT ISOCEN NEUTRON THERAPY SYS

FDA 510(k)

FDA Class 2 ·Radiology

Prostate-Specific Antigen (Psa) For Management Of Prostate Cancers

FDA Pre-Market Approval

FDA Class 2 ·BAYER IMMUNO 1 SYSTEM

Bella-mu

FDA 510(k)

FDA Class 2 ·General Hospital

SPS-1TM STATIC PRESERVATION SOLUTION, MODELS SPS-1-500 ML, SPS 1-1L, SPS-1-2L

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

Catheters, Transluminal Coronary Angioplasty, Percutaneous

FDA Pre-Market Approval

FDA Class 2 ·RX CHASSIS I CORONARY DILATATION CATHETER

INFANT MANUAL RESUSCITATOR (PMR 2)

FDA 510(k)

FDA Class 2 ·Anesthesiology

AIR VIVA II

FDA 510(k)

FDA Class 2 ·Anesthesiology