NvisionVLE Low-profile Optical Probe

FDA 510(k)

FDA Class 2 ·Radiology

LuminScan (TM) Imaging System

FDA 510(k)

FDA Class 2 ·Radiology

OPTIS Integrated System Mobile Workstation

FDA 510(k)

FDA Class 2 ·Radiology

HF-OCT Imaging System with Vis-RX Micro-Imaging Catheter (G10 (HF-OCT Console), G30 (Vis-Rx Micro-Imaging Catheter))

FDA 510(k)

FDA Class 2 ·Radiology

SKINTELL

FDA 510(k)

FDA Class 2 ·Radiology

C7 XR IMAGING SYSTEM

FDA 510(k)

FDA Class 2 ·Radiology

Digital Blood Pressure Monitor (Arm Type)

FDA 510(k)

FDA Class 2 ·Cardiovascular

Image1 S CCU, Image1 S 4U Camera Head

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

ACU-RAY HF SERIES PORTABLE X-RAY UNIT

FDA 510(k)

FDA Class 2 ·Radiology

CONGRUENT BONE PLATE SYSTEM: ACU-LOC 2 PLATE

FDA 510(k)

FDA Class 2 ·Orthopedic

ACU-CLENS CLEANING SYSTEM FOR CONTACT LENS CLEANING

FDA 510(k)

FDA Class 2 ·Ophthalmic

ACU-SINCH REPAIR SYSTEM AND ACUMED SUTURE ANCHOR

FDA 510(k)

FDA Class 2 ·Orthopedic

DSD-91(TM) DISINFECTOR FOR FLEXIBLE ENDOSCOPES

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

PFM PROFESSIONAL 7000 SPIROMETER

FDA 510(k)

FDA Class 2 ·Anesthesiology

PUL-TRON 100K PROFESSIONAL SPIROMETER

FDA 510(k)

FDA Class 2 ·Anesthesiology

AEMED STIMPAD ACU-TENS TRANSCUTANEOUS ELECTRICAL NERVE STIMULATOR, MODEL 021999

FDA 510(k)

FDA Class 2 ·Neurology

Notal Vision Home Optical Coherence Tomography (OCT) System

FDA 510(k)

FDA Class 2 ·Ophthalmic

TipVision Videoscope System (TipVision VideoScope 0°/30°; EleVision HD 2 Camera Control Unit (CCU))

FDA 510(k)

FDA Class 2 ·Obstetrics/Gynecology

Classic Cotton Cannulatome®, CannulaTome II® Double Lumen Sphincterotome, Cotton CannulaTome II® PC, UTS® Ultra Taper Sphincterotome, Tri-Tome pc® Triple Lumen Sphincterotome, Howell D.A.S.H.® Sphincterotome with DomeTip®, Billroth II Sphincterotome, Soehendra® BII Sphincterotome, Models ACU-1 and ACU-1-VL active cords

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

Access PCT

FDA 510(k)

FDA Class 2 ·Microbiology