Dual-Safety Pen Needle

FDA 510(k)

FDA Class 2 ·General Hospital

Radiofrequency Generator System, Cura RF Electrode

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

Electric Wheelchair (Robooter E60) (BBR-E60-01); Electric Wheelchair (Robooter E60) (BBR-E60-02); Electric Wheelchair (Robooter E60) (BBR-E60-03); Electric Wheelchair (Robooter E60) (BBR-E60-04); Electric Wheelchair (Robooter E60) (BBR-E60-05); Electric Wheelchair (Robooter E60) (BBR-E60-06); Electric Wheelchair (Robooter E60) (BBR-E60-07); Electric Wheelchair (Robooter E60) (BBR-E60-08)

FDA 510(k)

FDA Class 2 ·Physical Medicine

Wrist Blood Pressure Monitor

FDA 510(k)

FDA Class 2 ·Cardiovascular

Auto CPAP System

FDA 510(k)

FDA Class 2 ·Anesthesiology

easyPPHTM Hemorrhoidal Stapler for Single Use

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

Electric Wheelchair (Robooter E40), Model name: BBR-E40-01

FDA 510(k)

FDA Class 2 ·Physical Medicine

Diode Laser Hair Removal System (RD-SLD600)

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

EYE SECRET 38 UV ASPHERIC (POLYMACON) SOFT (HYDROPHILIC) CONTACT LENS FOR DAILY WEAR

FDA 510(k)

FDA Class 2 ·Ophthalmic

Rooti Rx ECG Event Recorder, Rooti Link APP Software

FDA 510(k)

FDA Class 2 ·Cardiovascular

AmCAD-US

FDA 510(k)

FDA Class 2 ·Radiology

AssureTech Buprenorphine Tests (Strip, Panel Dip, Quick Cup, Turn-Key Split Cup), AssureTech Methadone Tests (Strip, Panel Dip, Quick Cup, Turn-Key Split Cup)

FDA 510(k)

FDA Class 2 ·Clinical Toxicology

Digital Wireless Intraoral X-Ray Sensor

FDA 510(k)

FDA Class 2 ·Dental

Silicone Urethral Catheter (Silicone Urethral Catheter)

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

Bone Marrow Biopsy Needle

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

EYE SECRET 55 UV ASPHERIC (METHAFILCON A) SOFT (HYDROPHILIC) CONTACT LENS

FDA 510(k)

FDA Class 2 ·Ophthalmic

Phototherapy System (OL-PDT950)

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

Eye Secret 55 UV Aspheric (Methafilcon A) Soft (hydrophilic) Contact Lens

FDA 510(k)

FDA Class 2 ·Ophthalmic

R190/R191 LCD Monitor

FDA 510(k)

FDA Class 2 ·Radiology

Sunsphere

FDA 510(k)

FDA Class 2 ·Cardiovascular