NIDEK, INC. BIO-DC LASER DELIVERY SYSTEM

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

NIDEK INC. MODEL AC-2000 DERM

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

NIDEK INC. MODELS YC-2000 & 3000 OPHTHALMIC LASERS

FDA 510(k)

FDA Class 2 ·Ophthalmic

MODEL DC-1200 DIODE LASER PHOTOCOAGULATOR

FDA 510(k)

FDA Class 2 ·Ophthalmic

NIDEK MODEL YC-1200

FDA 510(k)

FDA Class 2 ·Ophthalmic

MODEL YC-1200/PHOTOCOAGULATOR OPHTHALMIC LASER

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

NIDEK, INC. MODELS YC-1100 OPHTHALMIC LASERS

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

NIDEK MODEL AKC-8000 OPHTHALMIC LASER PHOTOCOAGULA

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

Full Field Digital, System, X-Ray, Mammographic

FDA Pre-Market Approval

FDA Class 2 ·SELENIA FULL FIELD DIGITAL MAMMOGRAPHY SYSTEM

Full Field Digital, System, X-Ray, Mammographic

FDA Pre-Market Approval

FDA Class 2 ·HOLOGIC SELENIA DIMENSIONS 2D FULL FIELD DIGITAL MAMMOGRAPHY SYSTEM

X-RAY UNIT, PORTABLE GX-101 AEC

FDA 510(k)

FDA Class 2 ·Radiology

MODIFICATION TO REFLEX AEC LINEAR STAPLER/CUTTER

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

System, Test, Carcinoembryonic Antigen

FDA Pre-Market Approval

FDA Class 2 ·ABBOTT CEA-EIA

System, Test, Carcinoembryonic Antigen

FDA Pre-Market Approval

FDA Class 2 ·CEA-RIA MONOCLONAL

System, Test, Carcinoembryonic Antigen

FDA Pre-Market Approval

FDA Class 2 ·ABBOTT CEA-EIA

System, Test, Carcinoembryonic Antigen

FDA Pre-Market Approval

FDA Class 2 ·ABBOTT CEA-EIA

SCOOTA BUG (MOTORIZED VEHICLE)

FDA 510(k)

FDA Class 2 ·Physical Medicine

STERLING (MOTORIZED VEHICLE)

FDA 510(k)

FDA Class 2 ·Physical Medicine

SCOOTA MOTORIZED VEHICLE

FDA 510(k)

FDA Class 2 ·Physical Medicine

TARGA (WHEELCHAIR)

FDA 510(k)

FDA Class 2 ·Physical Medicine