THE CORE (CARDIAC OUTPATIENT REALTIME ECG) MONITOR

FDA 510(k)

FDA Class 2 ·Cardiovascular

SEP-10S PLUS, AND SP-12S PRO.

FDA 510(k)

FDA Class 2 ·General Hospital

COMPUTED TOMOGRAPHY COUCH PAD FOR MIN ANALYSIS

FDA 510(k)

FDA Class 2 ·Radiology

VIVACE

FDA 510(k)

FDA Class 2 ·Obstetrics/Gynecology

SGS ECCOVISIONTM Pharyngometer, SGS ECCOVISIONTM Rhinometer, SGS ECCOVISIONTM Rhino/Pharyngometer

FDA 510(k)

FDA Class 2 ·Anesthesiology

QCT-BONE MINERAL ANALYSIS SOFTWARE

FDA 510(k)

FDA Class 2 ·Radiology

HemoScreen Hematology Analyzer

FDA 510(k)

FDA Class 2 ·Hematology

ReDs Wearable System

FDA 510(k)

FDA Class 2 ·Cardiovascular

IntelliSpace Portal Platform

FDA 510(k)

FDA Class 2 ·Radiology

FRESENIUS HAEMODIALYSIS ;MACHINE A1008

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

Infrascanner

FDA 510(k)

FDA Class 2 ·Ophthalmic

ZIRACE

FDA 510(k)

FDA Class 2 ·Dental

IGI-SYSTEM

FDA 510(k)

FDA Class 2 ·Neurology

HemoScreen Hematology Analyzer

FDA 510(k)

FDA Class 2 ·Hematology

Disposable Surgical Mask

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

Disposable Surgical Gown (Level 3, MF2103 Series), Disposable Surgical Gown (Level 3, MF2104 Series), Disposable Surgical Gown (Level 4, MF2105 Series)

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

PRETTAU ANTERIOR T0

FDA 510(k)

FDA Class 2 ·Dental

ESOP S/C FEMORAL STEM

FDA 510(k)

FDA Class 2 ·Orthopedic

CABOCHON SYSTEM

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

ATLAS III ACETABULAR CUP

FDA 510(k)

FDA Class 2 ·Orthopedic