FUJIFILM Endoscope Model EC-760Z-V/L

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

EarlySense Central Display Station (CDS)

FDA 510(k)

FDA Class 2 ·Cardiovascular

Intrisound™ Tuned Lumen® 155 Hearing Aids

FDA 510(k)

FDA Class 2 ·Ear, Nose, Throat

FUJIFILM Processor EP-8000; FUJIFILM Endoscope Model EG-860R

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

EVERON CENTRAL DISPLAY STATION - CDS, MODEL VERSION 1.0.0

FDA 510(k)

FDA Class 2 ·Cardiovascular

HS40 Diagnostic Ultrasound System

FDA 510(k)

FDA Class 2 ·Radiology

V8 Diagnostic Ultrasound System, V7 Diagnostic Ultrasound System

FDA 510(k)

FDA Class 2 ·Radiology

EARLYSENSE CENTRAL DISPLAY SYSTEM

FDA 510(k)

FDA Class 2 ·Cardiovascular

EVICEL APPLICATION DEVICE

FDA 510(k)

FDA Class 2 ·General Hospital

HERA W9 Diagnostic Ultrasound System, HERA W10 Diagnostic Ultrasound System

FDA 510(k)

FDA Class 2 ·Radiology

EVICEL APPLICATION DEVICE

FDA 510(k)

FDA Class 2 ·General Hospital

Synapse 3D Optional Tools

FDA 510(k)

FDA Class 2 ·Radiology

RS85 Diagnostic Ultrasound System

FDA 510(k)

FDA Class 2 ·Radiology

HERA W10 Diagnostic Ultrasound System; HERA W9 Diagnostic Ultrasound System

FDA 510(k)

FDA Class 2 ·Radiology

HERA W10 Diagnostic Ultrasound System

FDA 510(k)

FDA Class 2 ·Radiology

FUJIFILM Endoscope Model EC-860P/M; FUJIFILM Endoscope Model EC-860P/L; FUJIFILM Endoscope Model EC-860S/L

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

LUMENIS PULSE 120H

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

NOGA AUTOMATED SLEEP STUDY SCORING AND DATA MANAGEMENT SYSTEM

FDA 510(k)

FDA Class 2 ·Anesthesiology

HS50/HS60 Diagnostics Ultrasound System

FDA 510(k)

FDA Class 2 ·Radiology

FUJIFILM Endoscope Model EC-760S-A/L, Endoscopy Support Program EW10-VM01

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology