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

iNod Ultrasound Guided Biopsy Needle (UPN: M00502060), iNod Ultrasound Guidance Console (UPN: M00503210)

FDA 510(k)

FDA Class 2 ·Ear, Nose, Throat

MONARCH™ Platform (MON-000008)

FDA 510(k)

FDA Class 2 ·Ear, Nose, Throat

Ion Endoluminal System ; Flexision Biopsy Needle

FDA 510(k)

FDA Class 2 ·Ear, Nose, Throat

DIAGNOSTIC CATHETER SYSTEM

FDA 510(k)

FDA Class 2 ·Ear, Nose, Throat

MODIFICATION TO SUPERDIMENSION/BRONCHUS PREMIUM 2

FDA 510(k)

FDA Class 2 ·Ear, Nose, Throat

Broncoflex Agile, Broncoflex Vortex, Screeni

FDA 510(k)

FDA Class 2 ·Ear, Nose, Throat

MILL-ROSE HARRELL BRONCHIAL BRUSH

FDA 510(k)

FDA Class 2 ·Ear, Nose, Throat

Vathin® Video Bronchoscope System

FDA 510(k)

FDA Class 2 ·Ear, Nose, Throat

COMBICATH CATHETER

FDA 510(k)

FDA Class 2 ·Ear, Nose, Throat

Captura Disposable Bronchoscope Biopsy Forceps

FDA 510(k)

FDA Class 2 ·Ear, Nose, Throat

Ambu® aScope™ 5 Broncho 2.7/1.2, Ambu® aScope™ 5 Broncho 4.2/2.2, Ambu® aBox™ 2

FDA 510(k)

FDA Class 2 ·Ear, Nose, Throat

Flexible Intubation Video Endoscope – Sterile (FIVE-S)

FDA 510(k)

FDA Class 2 ·Ear, Nose, Throat

KARL STORZ INTUBATION FIBERSCOPE

FDA 510(k)

FDA Class 2 ·Ear, Nose, Throat

MILL-ROSE BLIND MICROBIOLOGY BRUSH

FDA 510(k)

FDA Class 2 ·Ear, Nose, Throat

FUJIFILM Bronchoscope

FDA 510(k)

FDA Class 2 ·Ear, Nose, Throat

AMBU ASCOPE 3 5.0/2.2; AMBU ASCOPE 3 SLIM 3.8/1.2; AMBU AVIEW

FDA 510(k)

FDA Class 2 ·Ear, Nose, Throat

Broncho Videoscope System (Single-use Broncho Videoscope (SBV-1A-B, SBV-1A-P, SBV-1B-B, SBV-1B-P, SBV-1C-B, SBV-1C-P); Full HD Visualization Endoscopic Image Processor (HDVS-S300A, HDVS-S300B, HDVS-S300C, HDVS-S300D); Endoscopic Image Processor (HDVS-S100A, HDVS-S100D))

FDA 510(k)

FDA Class 2 ·Ear, Nose, Throat

ENDOSCOPIC COUPLER

FDA 510(k)

FDA Class 2 ·Ear, Nose, Throat

FUJINON/FUJIFILM ULTRASONIC ENDOSCOPE EB-530US

FDA 510(k)

FDA Class 2 ·Ear, Nose, Throat