PHONAK SONA P2

FDA 510(k)

FDA Class 1 ·Ear, Nose, Throat

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

PORTABLE X-RAY SYSTEM, MODEL DXR -1

FDA 510(k)

FDA Class 2 ·Dental

CHOYANG THERMAL MASSAGER

FDA 510(k)

FDA Class 2 ·Physical Medicine

LEFORTE SYSTEM BONE PLATE

FDA 510(k)

FDA Class 2 ·Dental

EYEGLASS FRAMES

FDA 510(k)

FDA Class 1 ·Ophthalmic

Test, Hepatitis B (B Core, Be Antigen, Be Antibody, B Core Igm)

FDA Pre-Market Approval

FDA Class 3 ·DIASORIN ETI-AB-AUK PLUS ASSAY