BWF-5 MEDICAL LASER SERIES

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

BWF-5 MEDICAL LASER SERIES

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

FastStroke

FDA 510(k)

FDA Class 2 ·Radiology

EUROIMMUN ANTI-GLIADIN (GAF-3X) ELISA (IGA)

FDA 510(k)

FDA Class 2 ·Immunology

EUROIMMUN ANTI-GLIADIN (GAF-3X) ELISA (IGG)

FDA 510(k)

FDA Class 2 ·Immunology

GENERAL PATIENT MONITORS, MODELS: G3C/ G3D/ G3F/ G3G/ G3H

FDA 510(k)

FDA Class 2 ·Cardiovascular

SIMPLA TRIDENT LEG BAG + SIMPLA S6 BAG

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

Lenses, Soft Contact, Daily Wear

FDA Pre-Market Approval

FDA Class 2 ·TRI POL 43R HYDROPHILIC CONTACT LENS

Lenses, Soft Contact, Daily Wear

FDA Pre-Market Approval

FDA Class 2 ·TRI POL 43 CONTACT LENS

Lenses, Soft Contact, Daily Wear

FDA Pre-Market Approval

FDA Class 2 ·V-X (POLYMACON) ASPHERIC SOFT(HYDROPHILIC) LENSES

Lenses, Soft Contact, Daily Wear

FDA Pre-Market Approval

FDA Class 2 ·TRI POL 43 CONTACT LENS

Lenses, Soft Contact, Daily Wear

FDA Pre-Market Approval

FDA Class 2 ·TRI POL 43 CONTACT LENS

BWF-5 MEDICAL LASER SERIES, 810 NM; 930 NM; 980 NM; 1080 NM

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

CURIETRON 192 LOW DOSE RATE

FDA 510(k)

FDA Class 2 ·Radiology

hekaDrill

FDA 510(k)

FDA Class 2 ·Ear, Nose, Throat

SIMPLA S4, S5, S7

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

hekaDrill

FDA 510(k)

FDA Class 2 ·Neurology

EMMA 1.5T MRI System

FDA 510(k)

FDA Class 2 ·Radiology

HTS EXTREMITY COIL, HTS SURFACE COIL

FDA 510(k)

FDA Class 2 ·Radiology

SYSTEM 70 AND 100

FDA 510(k)

FDA Class 2 ·Physical Medicine