MODEL DELTA, OM OXYGEN CONCENTRATOR

FDA 510(k)

FDA Class 2 ·Anesthesiology

SUPPORT RING

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

MINOS AUTOMATIC CELL COUNTER

FDA 510(k)

FDA Class 2 ·Hematology

ELITE(TM) ZIRCONIA TOTAL HIP BALL HEAD SYSTEM

FDA 510(k)

FDA Class 2 ·Orthopedic

RMNIPULSE HOLMIUM LASER SYSTEM/1210; MAX/1210-VHP; JR. 1230-30; N/A 1500-A

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

POWER TEK II

FDA 510(k)

FDA Class 2 ·Orthopedic

PRESSURE MONITOR CATH MODELS SP5325,SP5327,SP5337

FDA 510(k)

FDA Class 2 ·Cardiovascular

ACELL UBM SURGICAL MESH

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

SINGLE CHANNEL NONFADE OSCILLOSCOPE

FDA 510(k)

FDA Class 2 ·Cardiovascular

ENDOHELIX ENDARTERECTOMY DEVICE

FDA 510(k)

FDA Class 2 ·Cardiovascular

ABDOMINAL PRESSURE CONTROL VALVE

FDA 510(k)

FDA Class 2 ·Obstetrics/Gynecology

INTEGRA EXPANDABLE INTERVEREBRAL BODY FUSION DEVICE (IBD) SYSTEM

FDA 510(k)

FDA Class 2 ·Orthopedic

BOX DICOM Viewer

FDA 510(k)

FDA Class 2 ·Radiology

WELLAHO PERSONALIZED OUTPATIENT MANAGEMENT SYSTEM

FDA 510(k)

FDA Class 2 ·Cardiovascular

SPACELABS ICR ARRHYTHMIA MASTER I HOLTER

FDA 510(k)

FDA Class 2 ·Cardiovascular

ULTRA-VU ANGIOSCOPE

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

OtoSight Middle Ear Scope

FDA 510(k)

FDA Class 2 ·Radiology

HANDPIECE FOR NIDEK CV-12000 PHACO SYSTEM

FDA 510(k)

FDA Class 2 ·Ophthalmic

QUINTON Q.CATH

FDA 510(k)

FDA Class 2 ·Cardiovascular

LIPOGEN ANA TEST KIT

FDA 510(k)

FDA Class 2 ·Immunology