Phagenyx System

FDA 510(k)

FDA Class 2 ·Ear, Nose, Throat

MA600-IMPEDANCE AUDIOMETER

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

MODEL V4 AUDIOMETER

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

VenSure™ Balloon Dilation System, VenSure™ Light Balloon Dilation System, VenSure™ Nav Balloon Dilation System, VenSure™ ET Balloon Dilation System

FDA 510(k)

FDA Class 2 ·Ear, Nose, Throat

Peace N Quiet (0.7.0)

FDA 510(k)

FDA Class 2 ·Ear, Nose, Throat

MODEL 2100 ND:YAG SURGICAL LASER PULMONARY INDICAT

FDA 510(k)

FDA Class 2 ·Ear, Nose, Throat

MONARCH™ Platform (MON-000008)

FDA 510(k)

FDA Class 2 ·Ear, Nose, Throat

SHILEY CRICOTHYROTOMY TUBE

FDA 510(k)

FDA Class 2 ·Ear, Nose, Throat

DISPOSABLE ENDOSHEATH FOR E-F100 FLEXIBLE NASOPHARYNGOSCOPE

FDA 510(k)

FDA Class 2 ·Ear, Nose, Throat

DSP SCREENING AUDIOMETER

FDA 510(k)

FDA Class 2 ·Ear, Nose, Throat

XENF-DP RHINO-LARYNGOFIBERSCOPE, ITS ACCESSORIES AND ANCILLARY EQUIPMENT

FDA 510(k)

FDA Class 2 ·Ear, Nose, Throat

Waypoint GPS

FDA 510(k)

FDA Class 2 ·Ear, Nose, Throat

OES THORACOSCOPE SYSTEM

FDA 510(k)

FDA Class 2 ·Ear, Nose, Throat

INTERACOUSTICS DIAGNOSTIC AUDIOMETER

FDA 510(k)

FDA Class 2 ·Ear, Nose, Throat

BLACKSTAR(TM) STAR SYSTEM

FDA 510(k)

FDA Class 2 ·Ear, Nose, Throat

ND: YAGLASER FOR PALLIATIVE TREAT OF OBSTRUCTION

FDA 510(k)

FDA Class 2 ·Ear, Nose, Throat

OTOMETER PORTABLE SCREENING AUDIOMETER

FDA 510(k)

FDA Class 2 ·Ear, Nose, Throat