Oral Surgery System and Accessories

FDA 510(k)

FDA Class 2 ·Dental

Pegavision (Hioxifilcon A) Daily Disposable Soft Contact Lenses

FDA 510(k)

FDA Class 2 ·Ophthalmic

Eye Secret 38 UV Aspheric Color(polymacon) Soft(hydrophilic) Contact Lens for Daily;Eye Secret 38 UV Aspheric Color(polymacon) 1-Day Soft(hydrophilic) Contact Lens

FDA 510(k)

FDA Class 2 ·Ophthalmic

Assure Tech hCG Pregnancy Serum/Urine Combo Test Cassette, Assure Tech hCG Pregnancy Serum/Urine Combo Test Strip

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

Eye Secret 38 UV Aspheric (polymacon) Soft (hydrophilic) Contact Lens for Daily Wear, Eye Secret 55 UV Aspheric ( methafilcon A) Soft (hydrophilic) Contact lens for Daily Wear

FDA 510(k)

FDA Class 2 ·Ophthalmic

easyEndoTM Linear Cutting Stapler and Loading Units for Single Use, easyEndoTM Universal Linear Cutting Stapler and Loading Units for Single Use

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

Al Smile Aligner

FDA 510(k)

FDA Class 2 ·Dental

Male, Nelaton-tip Ready-to-Use Hydrophilic Catheter; Femal, Nelaton-tip Ready-to-Use Hydrophilic Catheter; Pediatric, Nelaton-tip Ready-to-Use Hydrophilic Catheter Intermittent Catheter; Male, Tapered-Tip Tiemann Ready-to-Use Hydrophilic Catheter; Male, Olive-Tip Tiemann Ready-to-Use Hydrophilic Catheter

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

Electric Wheelchair

FDA 510(k)

FDA Class 2 ·Physical Medicine

Home Use Hair Removal Device (Model(s):T10A, T10B, T10C, T10D, T11A, T15A, T17A, T18A, T14A, T16A, T19A)

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

Electronic Blood Pressure Monitor

FDA 510(k)

FDA Class 2 ·Cardiovascular

Painless IPL System - KDT750

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

Infrared Thermometer: Model YJ600

FDA 510(k)

FDA Class 2 ·General Hospital

Automatic Core Biopsy Instrument/ Semi-Automatic Core Biopsy Instrument/ Disposable Coaxial Biopsy Needle

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

easyEndo Linear Cutting Stapler and Loading Unit for Single Use(Stapler;Loading Unit)

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

Intermittent nelaton catheter for single use

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

AmCAD-UV

FDA 510(k)

FDA Class 2 ·Radiology

Surgical Mask

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

Sejoy Blood Glucose Monitoring System; Sejoy Advance Link Blood Glucose Monitoring System

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

aetherSlide

FDA 510(k)

FDA Class 2 ·Pathology