Single-use Video Pancreaticobiliary Scope, PB Digital Controller

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

Diagnostic X-ray System/PLX5200A

FDA 510(k)

FDA Class 2 ·Radiology

Segmented Esophageal Stent System

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

Guidewire Locking Device

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

JUSHA-C350G LCD Monitor, JUSHA-C350 LCD Monitor, C350G LCD Monitor, C350 LCD Monitor

FDA 510(k)

FDA Class 2 ·Radiology

Sphincterotome / short-wire compatible, Sterile Sphincterotome

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

Cytology Brush

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

Extraction Basket

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

Grasping Forceps

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

Through the Scope Tracheal Stent System

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

Areus(TM) Adapt Endoscopic Ultrasound Aspiration Needle, Tridemt(TM) Endoscopic Ultrasound Aspiration Needle

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

Reliant(TM) Multistage Dilatation Balloon Catheter

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

Intense Pulsed Light Treatment System (LK-PT)

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

M Biopsy /SureCore Automatic Disposable Biopsy Needle, M Biopsy /SureCore Semi-Automatic Disposable Biopsy Needle, M Biopsy /SureAim Coaxial Biopsy Needle

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

Ensure Single-Use Coagulation Forceps

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

Esophageal Stent System

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

Disposable Dual Action Tissue Clip

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

Reliant Multistage Dilatation Balloon Catheter

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

JUSHA-C270G/ JUSHA-C270/ C270G/ C270 LCD Monitor

FDA 510(k)

FDA Class 2 ·Radiology

Minimally Invasive Prostate Surgery Navigation System

FDA 510(k)

FDA Class 2 ·Radiology