BFlex™ 2 Slim 3.8 Single-Use Bronchoscope

FDA 510(k)

FDA Class 2 ·Ear, Nose, Throat

COAGULATION ELECTRODE, MODEL 2000; RADIOFREQUENCY GENERATOR, MODEL 20-115

FDA 510(k)

FDA Class 2 ·Ear, Nose, Throat

Ambu aScope 3 Slim 3.8/1.2 and Ambu aScope 4 Broncho Slim 3.8/1.2; Ambu aScope 3 Regular 5.0/2.2 and Ambu aScope 4 Broncho Regular 5.0/2.2; Ambu aScope 3 Large 5.8/2.8 and Ambu aScope 4 Broncho Large 5.8/2.8; Ambu aView Monitor

FDA 510(k)

FDA Class 2 ·Ear, Nose, Throat

BRONCHIAL CATHETER SYSTEM

FDA 510(k)

FDA Class 2 ·Ear, Nose, Throat

OLYMPUS B5-2C/B7-2C BALLOON CATHETER

FDA 510(k)

FDA Class 2 ·Ear, Nose, Throat

EVIS 200 SYSTEM

FDA 510(k)

FDA Class 2 ·Ear, Nose, Throat

LUNGPOINT TOOLS (LUNGPOINT SHEATH, LUNGPOINT DILATION BALLOON)

FDA 510(k)

FDA Class 2 ·Ear, Nose, Throat

Ion Endoluminal System (IF1000)

FDA 510(k)

FDA Class 2 ·Ear, Nose, Throat

Broncho Videoscope System

FDA 510(k)

FDA Class 2 ·Ear, Nose, Throat

CANNULATED BIOPSY FORCEPS

FDA 510(k)

FDA Class 2 ·Ear, Nose, Throat

EXALT Model B Single-Use Bronchoscope (Slim), EXALT Model B Single-Use Bronchoscope (Regular), EXALT Model B Single-Use Bronchoscope (Large), EXALT Monitor

FDA 510(k)

FDA Class 2 ·Ear, Nose, Throat

KARL STORZ STENT APPLICATOR FORCEPS

FDA 510(k)

FDA Class 2 ·Ear, Nose, Throat

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

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