PONTOR 4 CF

FDA 510(k)

FDA Class 2 ·Dental

DFV CPG COLPOSCOPE

FDA 510(k)

FDA Class 2 ·Obstetrics/Gynecology

LRT ATTACHMENT

FDA 510(k)

FDA Class 2 ·Dental

CMV EARLY ANTIGEN TEST

FDA 510(k)

FDA Class 2 ·Microbiology

AUTO-VAC BIOPSY NEEDLE

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

LECTRAJET NEEDLE-FREE INJECTION SYSTEM, MODEL: M3 RA

FDA 510(k)

FDA Class 2 ·General Hospital

INFRARED EAR THERMOMETER, MODEL DX-707

FDA 510(k)

FDA Class 2 ·General Hospital

Intra medullary endo-transilluminating device (iMET device)

FDA 510(k)

FDA Class 2 ·Orthopedic

PRECINORM(R) PROTEIN

FDA 510(k)

FDA Class 2 ·Immunology

EFAI CARDIOSUITE CTA ACUTE AORTIC SYNDROME ASSESSMENT SYSTEM

FDA 510(k)

FDA Class 2 ·Radiology

EFAI PACS Picture Archiving and Communication System

FDA 510(k)

FDA Class 2 ·Radiology

EFAI Intelligent Cardiothoracic Ratio (iCTR) Assessment System

FDA 510(k)

FDA Class 2 ·Radiology

EFAI RTSuite CT HN-Segmentation System

FDA 510(k)

FDA Class 2 ·Radiology

EFAI Neurosuite CT Midline Shift Assessment System (MLS-CT-100)

FDA 510(k)

FDA Class 2 ·Radiology

EFAI Bonesuite XR Bone Age Pro Assessment System (BAP-XR-100)

FDA 510(k)

FDA Class 2 ·Radiology

THE FRIENDLYLIGHT ND: YAG LASERS

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

LIGHTLANCE LASER SKIN PERFORATOR

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

RUBELLA VIRUS ANTIGENS & CONTROLS

FDA 510(k)

FDA Class 2 ·Microbiology

RUBELISA TEST KIT

FDA 510(k)

FDA Class 2 ·Microbiology

ORTHO* CYTOMEGALOVIRUS IDENTIFICATION REAGENT

FDA 510(k)

FDA Class 2 ·Microbiology