CUSTOM INSTRUMENT DRAPE

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

MICROSCOPE DRAPE

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

Alzair Allergy Blocker

FDA 510(k)

FDA Class 2 ·General Hospital

AllerBlock Junior

FDA 510(k)

FDA Class 2 ·General Hospital

Wheelchair, Stair Climbing

FDA Pre-Market Approval

FDA Class 2 ·INDEPENDENCE (TM) IBOT 3000/4000 MOBILITY SYSTEM

Wheelchair, Stair Climbing

FDA Pre-Market Approval

FDA Class 2 ·ACCESS MOBILITY SYSTEM

Wheelchair, Stair Climbing

FDA Pre-Market Approval

FDA Class 2 ·ACCESS MOBILITY SYSTEM

Wheelchair, Stair Climbing

FDA Pre-Market Approval

FDA Class 2 ·INDEPENDENCE IBOT 3000 MOBILITY SYSTEM

Wheelchair, Stair Climbing

FDA Pre-Market Approval

FDA Class 2 ·INDEPENDENCE IBOT 3000/4000 MOBILITY SYSTEM

Resona I8W, Resona I8, Resona I8 Exp, Resona I8S, Resona I8T, Resona IY,Resona I8 Easi, Eagus I8 Easi, Nuewa I8W, Nuewa I8, Nuewa I8 Exp, NuewaI8S, Nuewa I8T, Imagyn I8, Imagyn I8S, Imagyn I8T, Imagyn I8 Exp, Nuewa IY Diagnostic Ultrasound System

FDA 510(k)

FDA Class 2 ·Radiology

RETINA TOMOGRAPH AND FLOWMETER

FDA 510(k)

FDA Class 2 ·Ophthalmic

RETINA FLOWMETER

FDA 510(k)

FDA Class 2 ·Ophthalmic

RETINA ANGIOGRAPH

FDA 510(k)

FDA Class 2 ·Ophthalmic

ViVi® Surgical Helmet System (ViVi® Helmet, ViVi® Helmet HPL, ViVi® Hood)

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

ELIA PR3S IMMUNOASSAY, ELIA MPOS IMMUNOASSAY, ELIA GBM IMMUNOASSAY, ELIA ANCA/GBM POSITIVE CONTROL 100, ELIA ANCA/GBM PO

FDA 510(k)

FDA Class 2 ·Immunology

ELIA M2; IMMUNOASSAY, POSITIVE CONTROL 100, POSITIVE CONTROL 250

FDA 510(k)

FDA Class 2 ·Immunology

ViVi® Toga Premium

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

Codman Electrosurgical Generator, Foot Pedal

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

Attachment, Intermittent Mandatory Ventilation (Imv)

FDA classification

FDA Class 2 ·Attachment, Intermittent Mandatory Ventilation (Imv)

CARDIOSMART

FDA 510(k)

FDA Class 2 ·Cardiovascular