GM85

FDA 510(k)

FDA Class 2 ·Radiology

LATEX FINGER COTS

FDA 510(k)

FDA Class 1 ·General Hospital

AXIR-CX

FDA 510(k)

FDA Class 2 ·Radiology

VERI-Q SELF-TESTING AND VERI-Q PLUS MGD-2001 BLOOD GLUCOSE MONITORING SYSTEMS

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

Internal Hex Implant System

FDA 510(k)

FDA Class 2 ·Dental

Ensol EnTM Specimen Collection and Transport System

FDA 510(k)

FDA Class 1 ·Microbiology

Vonflex S Putty

FDA 510(k)

FDA Class 2 ·Dental

COMPRESSIBLE LIMB THERAPY SYSTEM

FDA 510(k)

FDA Class 2 ·Physical Medicine

SPECTACLE FRAMES

FDA 510(k)

FDA Class 1 ·Ophthalmic

HANAROSTENT Esophagus TTS (CCC), HANAROSTENT Esophagus TTS (NCN)

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

EzDent Web

FDA 510(k)

FDA Class 2 ·Radiology

CX20N(CX20PUX)

FDA 510(k)

FDA Class 2 ·Radiology

Dyna Locking Trochanteric Nail™

FDA 510(k)

FDA Class 2 ·Orthopedic

reepot Nd; YAG laser system

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

BRAINSCAN WORKSTATION

FDA 510(k)

FDA Class 2 ·Neurology

DenQ Sub SLA Implant System

FDA 510(k)

FDA Class 2 ·Dental

Geo Abutment

FDA 510(k)

FDA Class 2 ·Dental

VIVA combo RF System (VIVA combo RF System)

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

Blue Eye

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

4CIS® Marlin ACIF Cage System

FDA 510(k)

FDA Class 2 ·Orthopedic