Elecsys ß-Amyloid (1-42) CSF II, Elecsys Total-Tau CSF

FDA 510(k)

FDA Class 2 ·Immunology

Lumipulse G ß-Amyloid Ratio (1-42/1-40)

FDA 510(k)

FDA Class 2 ·Immunology

Elecsys B-Amyloid (1-42) CSF II, Elecsys Phospho-Tau (181P) CSF

FDA 510(k)

FDA Class 2 ·Immunology

Alzheimer’S Disease Pathology Assessment Test

FDA classification

FDA Class 2 ·Alzheimer’S Disease Pathology Assessment Test

Winback Back 3SE

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

GENERATION 8 SE ADHESIVE

FDA 510(k)

FDA Class 2 ·Dental

SMART ECG SERIES ELECTROCARDIOGRAPH, MODELS SE-3, SE-300A AND 300B, SE-6, SE-600, SE-12, SE-12 EXPRESS AND SE-1200

FDA 510(k)

FDA Class 2 ·Cardiovascular

EMMA 1.5T MRI System

FDA 510(k)

FDA Class 2 ·Radiology

ENDOBRUSH(TM) DEVICE; OMNIBRUSH

FDA 510(k)

FDA Class 2 ·Obstetrics/Gynecology

NEONA 1.5T MRI System

FDA 510(k)

FDA Class 2 ·Radiology

Dental diode laser, SOGA Laser, ILaser II

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

Dental diode laser

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

CHLAMYDIA KIT, STD KIT

FDA 510(k)

FDA Class 2 ·Obstetrics/Gynecology

Sunkingdom Slit Lamp

FDA 510(k)

FDA Class 2 ·Ophthalmic

PAP SMEAR TRAY

FDA 510(k)

FDA Class 2 ·Obstetrics/Gynecology

Starly pad

FDA 510(k)

FDA Class 2 ·Neurology

EZVIEW (POLYMACON) SOFT (HYDROPHILLIC) CONTACT LENS FOR DAILY WEAR

FDA 510(k)

FDA Class 2 ·Ophthalmic

EZvue UV, Soft Daily Wear Contact Lenses (ocufilcon D), EZvue Colors, Soft Daily Wear Contact Lenses (ocufilcon D)

FDA 510(k)

FDA Class 2 ·Ophthalmic

EZVUE (OCUFILCON D) SOFT (HYDROPHILIC) CONTACT LENS FOR DAILY WEAR

FDA 510(k)

FDA Class 2 ·Ophthalmic

EZVUE (OCUFILCON D) 1-DAY SOFT (HYDROPHILIC)CONTACT LENS

FDA 510(k)

FDA Class 2 ·Ophthalmic