Ezi-Stick

FDA registration

MEDICLUS CO., LTD·1 product·🇰🇷 South Korea

ZrGEN Abutment

FDA registration

Megagen Implant Co., Ltd.·2 products·🇰🇷 South Korea

EZ Plus Implant System

FDA registration

Megagen Implant Co., Ltd.·1 product·🇰🇷 South Korea

ARIX Ankle Fibula Hook Plate System

FDA registration

JEIL MEDICAL CORPORATION·1 product·🇰🇷 South Korea

Zenius Spinal System

FDA 510(k)

FDA Class 2 ·Orthopedic

FOLEY CATHETER TRAY

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

SILICONE SPLINTING MATERIAL

FDA 510(k)

FDA Class 1 ·General, Plastic Surgery

MEDYSSEY ANTERIOR CERVICAL FUSION CAGE

FDA 510(k)

FDA Class 2 ·Orthopedic

SERVOMED BASIC BEDSIDE UNIT SMV 110TP

FDA 510(k)

FDA Class 2 ·Cardiovascular

Zenius™, lliad™ and Kora™ Spinal Fixation Systems

FDA 510(k)

FDA Class 2 ·Orthopedic

TELEDYNE GETZ'S DISPOSABLE PROPHY ANGLE

FDA 510(k)

FDA Class 1 ·Dental

FISCHER PPS/MAMMOTEST MAMMOGRAPHY SYSTEM

FDA 510(k)

FDA Class 2 ·Radiology

DENSPRO COARSE MINT PROPHY PASTE

FDA 510(k)

FDA Class 1 ·Dental

KIT PAK INCONTINENT SKIN CARE KIT

FDA 510(k)

FDA Class 1 ·Gastroenterology, Urology

RECOMED CARDIAC OUTPUT METER 236067-

FDA 510(k)

FDA Class 2 ·Cardiovascular

SCINTRON IV

FDA 510(k)

FDA Class 2 ·Radiology

SUPER STRENGTH DENTURE ADHESIVE CREAM

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

Iliad® Pedicle Screw System and Zenius® Pedicle Screw System

FDA 510(k)

FDA Class 2 ·Orthopedic

Triton Cage

FDA 510(k)

FDA Class 2 ·Orthopedic

DUAL VALVE ASPIRATION/LAVAGE CANNULA AND ASPIRATION/SUCTION PROBE

FDA 510(k)

FDA Class 2 ·Obstetrics/Gynecology