PENTAX Medical Video Colonoscope (EC38-i20cWL)

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

PENTAX Medical Video Esophagoscope EE17-J10

FDA 510(k)

FDA Class 2 ·Ear, Nose, Throat

PENTAX Medical Video Processor EPK-i8020c, PENTAX Medical Video Bronchoscope EB11-J10, PENTAX Medical Video Bronchoscope EB15-J10, PENTAX Medical Video Bronchoscope EB19-J10U, PENTAX Medical Ultrasound Video Bronchoscope EB19-J10U

FDA 510(k)

FDA Class 2 ·Ear, Nose, Throat

PENTAX Medical EG-J10U Endoscopic Ultrasound System - EG34-J10U Ultrasound Upper GI Video Scope (Convex Array Type), EG36-J10UR Ultrasound Upper GI Video Scope (Radial Array Type), EG38-J10UT Ultrasound Upper GI Video Scope (Convex Array Type)

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

PENTAX Medical Video Processor (EPK-i8020c)

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

PENTAX Medical Video Duedenoscope ED34-i10T2

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

PENTAX Medical Single Use Video Bronchoscope EB11-S01, PENTAX Medical Single Use Video Bronchoscope EB15-S01, PENTAX Medical Mobile Processor ONE-M, PENTAX Medical Mobile Processor Plug-In ONE-Dock

FDA 510(k)

FDA Class 2 ·Ear, Nose, Throat

PENTAX Medical EPK-i7010 Video Processor with EB Family of Scopes

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

PENTAX Medical ONE Pulmo Single Use Video Bronchoscope System

FDA 510(k)

FDA Class 2 ·Ear, Nose, Throat

PENTAX Medical Video Upper GI Scopes EG17-J10

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

PENTAX Medical Ultrasound Video Bronchoscope EB19-J10U

FDA 510(k)

FDA Class 2 ·Ear, Nose, Throat

PENTAX Medical Video Bronchoscopes, PENTAX Medical Video Naso-Pharyngo-Laryngoscope, and PENTAX Medical Ultrasond Video Bronchoscope

FDA 510(k)

FDA Class 2 ·Ear, Nose, Throat

PENTAX EG-3670URK ULTRASOUND VIDEO GASTROSCOPE + HI VISION PREIRUS

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

PENTAX Medical Ultrasound Upper GI Video Scope EG34-J10U, PENTAX Medical Ultrasound Upper GI Video Scope EG36-J10UR, PENTAX Medical Ultrasound Upper GI Video Scope EG38-J10UT, PENTAX Medical Ultrasound Video Bronchoscope EB19-J10U

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

C2 CryoBalloon Ablation System (C2 CryoBalloon Ablation System)

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

PENTAX Medical Video Processor EPK-i8020c, PENTAX Medical Video Upper GI Scope EG29-i20c, PENTAX Medical Video Colonoscope EC38-i20cL

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

PENTAX Medical EPK-3000 Imaging System with Camera Head PVK-J10, PENTAX Medical ENT Imaging System with Camera Head PVK-J10

FDA 510(k)

FDA Class 2 ·Ear, Nose, Throat

Nasometer

Basic UDI-DI

EU MDR · Eu Md Class 1 ·PENTAX of America Inc.·1 device

C2 CryoBalloon EndoGrip

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

C2 CryoBalloon Catheter (Pear), C2 CryoBalloon (Standard), C2 CryoBalloon Controller, C2 CryoBalloon Foot Pedal, C2 CryoBalloon Cartridge

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery