NIDEK INC. MODELS YC-2000 & 3000 OPHTHALMIC LASERS

FDA 510(k)

FDA Class 2 ·Ophthalmic

CURRY MULTIMODAL NEUROIMAGING SOFTWARE

FDA 510(k)

FDA Class 2 ·Neurology

ELECTROSURGICAL UNIT 774

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

SPIES 3D Tip Cam, Image 1 SPIES CCU Image Connect, Image 1 SPIES CCU D-3 Link

FDA 510(k)

FDA Class 2 ·Obstetrics/Gynecology

CMOS Video-Rhino-Laryngoscope System

FDA 510(k)

FDA Class 2 ·Ear, Nose, Throat

TXM Hydrophilic Guidewire

FDA 510(k)

FDA Class 2 ·Cardiovascular

Hope&Her Vaginal Dilators

FDA 510(k)

FDA Class 2 ·Obstetrics/Gynecology

KARL STORZ LED NOVA 100 COLD LIGHT FOUNTAIN, MODELS 2016020, 20161020C

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

Image1 SPIES System

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

Telepack +

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

Xultan 5.5 Pedicle Screw System

FDA 510(k)

FDA Class 2 ·Orthopedic

ELECTROCARDIOGRAM DISPOS. ELECTRODE PAD

FDA 510(k)

FDA Class 2 ·Cardiovascular

AEROSOL MASKS, 81426, 81476, 81490 & 81492

FDA 510(k)

FDA Class 2 ·Anesthesiology

Virtu C Spinal Implant System

FDA 510(k)

FDA Class 2 ·Orthopedic

FLEXIBLE CMOS-VIDEO-CYSTO-URETHROSCOPE

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

SURGICAL CAUTERIES MODELS 775-11,12,13,31,32 & 33

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

KSEA BIPOLAR ELECTRODE

FDA 510(k)

FDA Class 2 ·Obstetrics/Gynecology

VENTURI OXYGEN MASK

FDA 510(k)

FDA Class 1 ·Anesthesiology

VIEW 1 IMAGING

FDA 510(k)

FDA Class 2 ·Radiology

TARGET COCAINE METABOLITE-R

FDA 510(k)

FDA Class 2 ·Clinical Toxicology