SYLFIRM X

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

CARDIPIA ECG / Model: CARDIPIA400H, CARDIPIA800H

FDA 510(k)

FDA Class 2 ·Cardiovascular

WeSensor

FDA 510(k)

FDA Class 2 ·Dental

DIGITAL BLOOD PRESSURE MONITOR, MODELS HD-503 AND HD-505

FDA 510(k)

FDA Class 2 ·Cardiovascular

HANYANG SUNGLASSES

FDA 510(k)

FDA Class 1 ·Ophthalmic

THE Cover

FDA 510(k)

FDA Class 2 ·Dental

AT-Patch ECG Analysis System

FDA 510(k)

FDA Class 2 ·Cardiovascular

AQUASPLASH (Polymacon) Soft (Hydrophilic) Daily Wear Contact Lens

FDA 510(k)

FDA Class 2 ·Ophthalmic

COMFORT COUGH

FDA 510(k)

FDA Class 2 ·Anesthesiology

ARIX FOOT SYSTEM

FDA 510(k)

FDA Class 2 ·Orthopedic

WS80A Diagnostic Ultrasound System

FDA 510(k)

FDA Class 2 ·Radiology

CIMILRE Free-T2 Plus

FDA 510(k)

FDA Class 2 ·Obstetrics/Gynecology

ARIX Rib System

FDA 510(k)

FDA Class 2 ·Orthopedic

IH Implant System

FDA 510(k)

FDA Class 2 ·Dental

AnyPlus Navigated Instruments System

FDA 510(k)

FDA Class 2 ·Neurology

SD GlucoNFC Blood Glucose Monitoring System, SD GlucoNFC Multi Blood Glucose Monitoring System

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

27HJ713S

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

Honorst Implant System

FDA 510(k)

FDA Class 2 ·Dental

BIJOU Orthodontic Ceramic Bracket

FDA 510(k)

FDA Class 2 ·Dental

Dyflex-II

FDA 510(k)

FDA Class 2 ·Orthopedic