WIDEXLINK IN CLEAR SERIES HEARING AIDS

FDA 510(k)

FDA Class 2 ·Ear, Nose, Throat

IE-ZEN (IN CLEAR SERIES HEARING AID)

FDA 510(k)

FDA Class 2 ·Ear, Nose, Throat

ZEN PROGRAM (MIND 440 HEARING AID)

FDA 510(k)

FDA Class 2 ·Ear, Nose, Throat

Analyzer, Medical Image

FDA Pre-Market Approval

FDA Class 2 ·IMAGECHECKER M1000 SYSTEM

MAKS CENTRAL DELIVERY SYS-11-200 ETC

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

ONTRAK TESTCUP M2K, MODEL CAT. 11 1849 8

FDA 510(k)

FDA Class 2 ·Clinical Toxicology

ROSA Bracket

FDA 510(k)

FDA Class 2 ·Dental

LEFORTE NEUROSYSTEM BONE SCREW

FDA 510(k)

FDA Class 2 ·Orthopedic

Orthodontic Fixation Screw [Smart Anchor Miniscrew]

FDA 510(k)

FDA Class 2 ·Dental

ZEN-2090 PRO, FLUOROSCOPIC X-RAY SYSTEM, MODEL ZEN-2090 PRO

FDA 510(k)

FDA Class 2 ·Radiology

EARLOGIC OAE TESTER

FDA 510(k)

FDA Class 2 ·Ear, Nose, Throat

INNESIS PEEK CAGE

FDA 510(k)

FDA Class 2 ·Orthopedic

VENUS Bracket, ROSE Bracket

FDA 510(k)

FDA Class 2 ·Dental

MEGA 5.5 SPINE SYSTEM

FDA 510(k)

FDA Class 2 ·Orthopedic

MAX PULSE SYSTEM

FDA 510(k)

FDA Class 2 ·Cardiovascular

PORTABLE X-RAY SYSTEM, MODELS DIOX-602, PROX

FDA 510(k)

FDA Class 2 ·Dental

SLIMUS

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

PORTABLE X-RAY SYSTEM, MODEL HAND-RAY

FDA 510(k)

FDA Class 2 ·Dental

MiNi Internal Implant System

FDA 510(k)

FDA Class 2 ·Dental

SA-3000P

FDA 510(k)

FDA Class 2 ·Cardiovascular