RUIKE, MODEL 3411

FDA 510(k)

FDA Class 2 ·Physical Medicine

FINGERTIP PULSE OXIMETER, MODEL M70, AND HANDHELD PULSE OXIMETER, MODEL M700

FDA 510(k)

FDA Class 2 ·Cardiovascular

OxyPure Color Silicone Hydrogel Soft Contact Lenses

FDA 510(k)

FDA Class 2 ·Ophthalmic

AERODR X70

FDA 510(k)

FDA Class 2 ·Radiology

Daily Breeze B (olifilcon B) Spherical Silicone Hydrogel Soft Contact Lens, Daily Breeze B (olifilcon B) Toric Silicone Hydrogel Soft Contact Lens, Daily Breeze B (olifilcon B) Multifocal Silicone Hydrogel Soft Contact Lens

FDA 510(k)

FDA Class 2 ·Ophthalmic

Optima XR646 HD

FDA 510(k)

FDA Class 2 ·Radiology

FORU, MODEL EQ30

FDA 510(k)

FDA Class 2 ·Physical Medicine

HydroSens A (hioxifilcon A) Spherical Hydrogel Soft Contact Lens

FDA 510(k)

FDA Class 2 ·Ophthalmic

FORU KV10HB

FDA 510(k)

FDA Class 2 ·Physical Medicine

TRAUSON BONE PLATE

FDA 510(k)

FDA Class 2 ·Orthopedic

TRAUSON GENERAL SPINAL SYSTEM (GSS)

FDA 510(k)

FDA Class 2 ·Orthopedic

BRIVO MR355, OPTIMA MR360

FDA 510(k)

FDA Class 2 ·Radiology

TRAUSON BONE SCREW, MODELS HA 3.5 AND 4.5

FDA 510(k)

FDA Class 2 ·Orthopedic

Vexillum (olifilcon B) with Tangible Polymers Silicone Hydrogel Soft Contact Lens; Daily Breeze (olifilcon B) Silicone Hydrogel Soft Contact Lens

FDA 510(k)

FDA Class 2 ·Ophthalmic

PICA WHOLE-BODY MRI SYSTEM

FDA 510(k)

FDA Class 2 ·Radiology

YOMURA SAFETY I.V. CATHETER

FDA 510(k)

FDA Class 2 ·General Hospital

KYMCO FORU, MODEL EQ10

FDA 510(k)

FDA Class 2 ·Physical Medicine

Surgical Face Mask (Non-sterile)

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

CLUNGENE Fentanyl Home Test Cassette; CLUNGENE Fentanyl Test Cassette

FDA 510(k)

FDA Class 2 ·Clinical Toxicology

LANDLEX, MODEL S403X

FDA 510(k)

FDA Class 2 ·Physical Medicine