GSI 70 AUDIOPATH SCREENER

FDA 510(k)

FDA Class 2 ·Ear, Nose, Throat

XPS 3000 SYSTEM

FDA 510(k)

FDA Class 2 ·Ear, Nose, Throat

AugMENTA Penile Implant

FDA 510(k)

FDA Class 2 ·Ear, Nose, Throat

ZEN PROGRAM (MIND 440 HEARING AID)

FDA 510(k)

FDA Class 2 ·Ear, Nose, Throat

EFFNER ILLUMINATED NASAL TRACHEOSTOMA SPECULUM

FDA 510(k)

FDA Class 2 ·Ear, Nose, Throat

AIRWAY FIBERSCOPES, MODELS LS-9, 0L-1, 0L-2 & PL-2

FDA 510(k)

FDA Class 2 ·Ear, Nose, Throat

COAPTITE LARYNGEAL AUGMENTATION SYSTEM 1CC & O.5CC, MODELS 0008021-1, 0008022-1

FDA 510(k)

FDA Class 2 ·Ear, Nose, Throat

MILLS INCUS HA SLEEVE

FDA 510(k)

FDA Class 2 ·Ear, Nose, Throat

TOTAL OSSICULAR REPLACEMENT PROSTHESIS (TORP)

FDA 510(k)

FDA Class 2 ·Ear, Nose, Throat

Ponto Bone Anchored Hearing system/ Abutment, 14mm. Ponto Bone Anchored Hearing System / Wide implant, 4mm, with abutment, 14 mm

FDA 510(k)

FDA Class 2 ·Ear, Nose, Throat

FISCH DRILL SYSTEM

FDA 510(k)

FDA Class 2 ·Ear, Nose, Throat

VOCALIS GEL

FDA 510(k)

FDA Class 2 ·Ear, Nose, Throat

FUJIFILM Bronchoscope

FDA 510(k)

FDA Class 2 ·Ear, Nose, Throat

Precision S 4K Sinuscope

FDA 510(k)

FDA Class 2 ·Ear, Nose, Throat

ER-7C CLINICAL PROBE MICROPHONE

FDA 510(k)

FDA Class 2 ·Ear, Nose, Throat

Ponto 4

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

SMITH & NEPHEW PORPS & TORPS

FDA 510(k)

FDA Class 2 ·Ear, Nose, Throat

SODEM HIGH SPEED SYSTEM (ELECTRIC) (EAR, NOSE, AND THROAT)

FDA 510(k)

FDA Class 2 ·Ear, Nose, Throat

KSEA UNIDRIVE II/II PLUS AND ENT ACCESSORIES

FDA 510(k)

FDA Class 2 ·Ear, Nose, Throat