IMMUNODOT AUTOIMMUNE SCREENING PANEL 1

FDA 510(k)

FDA Class 2 ·Immunology

IMMUMODOT AUTOIMMUNITY SCREENING PANEL 4

FDA 510(k)

FDA Class 2 ·Immunology

ADVANCE* PREGNANCY TEST ACP 2 PREGNANCY TEST

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

IMMUNODOT INFECTIOUS MONONUCLEOSIS TEST

FDA 510(k)

FDA Class 2 ·Immunology

IMMUNODOT THYROID AUTOIMMUNITY PANEL

FDA 510(k)

FDA Class 2 ·Immunology

IMMUNOWELL SM ANTIBODY TEST

FDA 510(k)

FDA Class 2 ·Immunology

ADVANCE* AND DAISY* PREGNANCY TEST

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

JOWIRE NEO'S PTCA CATHETER GUIDEWIRES, MODELS AG141000, AG142000, AG143000, AG141002, AG141010, AG14M060 & AG14M050

FDA 510(k)

FDA Class 2 ·Cardiovascular

MICROCIRRUS MEDICAL NEBULIZER

FDA 510(k)

FDA Class 2 ·Anesthesiology

Genesys Spine Apache® Anterior Lumbar Interbody Fusion System

FDA 510(k)

FDA Class 2 ·Orthopedic

Sunkingdom Applanation Tonometer SK-R, SK-T, SK-Q

FDA 510(k)

FDA Class 2 ·Ophthalmic

Diode laser therapy device

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

Intense pulsed light therapy device

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

Multi-parameter Patient Monitor, models C30

FDA 510(k)

FDA Class 2 ·Cardiovascular

Sunkingdom Ophthalmic Ultrasound Examination Instrument SK-3000A, SK-3000B, SK-3000C, SK-2000AP, SK-2000A, SK-2000P

FDA 510(k)

FDA Class 2 ·Radiology

KODAK POINT OF CARE CR 120, KODAK POINT OF CARE CR 140, KODAK POINT OF CARE CR 260

FDA 510(k)

FDA Class 2 ·Radiology

S-ROM ACETABULAR CUP(PART OF S-ROM 135TM TOTAL HIP

FDA 510(k)

FDA Class 2 ·Orthopedic

HEALTHCHECK(TM) HOME TEST FOR LOSS OF THE SENSE OF SMELL

FDA 510(k)

FDA Class 2 ·Ear, Nose, Throat

Electric Wheelchair

FDA 510(k)

FDA Class 2 ·Physical Medicine

Disposable EEG cable

FDA 510(k)

FDA Class 2 ·Neurology