RADMAX Digital Imaging Software

FDA 510(k)

FDA Class 2 ·Radiology

UNIdental Symphony Implant System

FDA 510(k)

FDA Class 2 ·Dental

Blue Eye (TS-905)

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

Traus SSG30 Surgical System

FDA 510(k)

FDA Class 2 ·Neurology

TOPAZ Mobile DR System

FDA 510(k)

FDA Class 2 ·Radiology

AOT & T-L Abutment

FDA 510(k)

FDA Class 2 ·Dental

Point implant system

FDA 510(k)

FDA Class 2 ·Dental

SHINA INSULIN SYRINGE-INCLUDING ACCU-SURE INSULIN SYRINGES

FDA 510(k)

FDA Class 2 ·General Hospital

JADE Mobile X-Ray

FDA 510(k)

FDA Class 2 ·Radiology

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

SONOACE 4500 DIAGNOSTIC ULTRASOUND IMAGING SYSTEM

FDA 510(k)

FDA Class 2 ·Radiology

HS40 Diagnostic Ultrasound System

FDA 510(k)

FDA Class 2 ·Radiology

FORTEC MI-150 DIGITAL BLOOD PRESSURE METER

FDA 510(k)

FDA Class 2 ·Cardiovascular

MI-328, MI-316, MI-388 DIGITAL THERMOMETER

FDA 510(k)

FDA Class 2 ·General Hospital

Stimulator, Peripheral Nerve, Non-Implanted, For Urinary Incontinence

FDA classification

FDA Class 2 ·Stimulator, Peripheral Nerve, Non-Implanted, For Urinary Incontinence

CEDIA Heroin Metabolite (6-AM) assay

FDA 510(k)

FDA Class 2 ·Clinical Toxicology

CEDIA Heroin Metabolite (6-AM) Assay

FDA 510(k)

FDA Class 2 ·Clinical Toxicology