M7/M7T DIAGNOSTIC ULTRASOUND SYSTEM

FDA 510(k)

FDA Class 2 ·Radiology

Electric Breast Pump, model: YM-8166

FDA 510(k)

FDA Class 2 ·Obstetrics/Gynecology

BLOOD GLUCOSE MONITORING SYSTEM

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

ADVIA CHEMISTRY MICROALBUMIN CALIBRATORS, _2 CALIBRATORS

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

OTC EMS STIMULATOR

FDA 510(k)

FDA Class 2 ·Physical Medicine

aprevo® anterior and lateral lumbar interbody fusion device; aprevo® anterior lumbar interbody fusion devices with interfixation; aprevo® transforaminal lumbar interbody fusion device

FDA 510(k)

FDA Class 2 ·Orthopedic

Disposable Non-invasive EEG Sensor

FDA 510(k)

FDA Class 2 ·Neurology

Laparoscopic Curved Spatula Electrode, Retractable, Aspiration Hole, 28cm ; Laparoscopic Wire J-Hook Electrode, Retractable, Aspiration Hole, 28cm ; Laparoscopic Wire L-Hook Electrode, Retractable, Aspiration Hole, 28cm; Laparoscopic Wire L-Hook Electrode, Retractable, Aspiration, 36cm ; Laparoscopic Flat L-Hook Electrode, Retractable, Aspiration Hole, 28cm ; Laparoscopic Straight Spatula Electrode, Hollow, 28cm ; Laparoscopic Curved Spatula Electrode, Hollow, 28cm; Laparoscopic Wire J

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

aprevo® transforaminal lumbar interbody fusion device

FDA 510(k)

FDA Class 2 ·Orthopedic

FULLY AUTOMATIC ELECTRONIC BLOOD PRESSURE MONITOR MODEL: KD-5963NU, KD-5008

FDA 510(k)

FDA Class 2 ·Cardiovascular

Fingertip Pulse Oximeter, models Alpine20, Alpine20A, Alpine20H, Alpine20HA, Alpine20B, Alpine20BA, Alpine20BH, Alpine20BHA, Alpine30, Alpine30A, Alpine30H, Alpine30HA, Alpine30B, Alpine30BA, Alpine30BH, Alpine30BHA, Alpine20L, Alpine20LB, Alpine20LH, Alpine20LBH, Alpine30L, Alpine30LB, Alpine30LH, Alpine30LBH

FDA 510(k)

FDA Class 2 ·Cardiovascular

AG-608 BLOOD GLUCOSE MONITORING SYSTEM AND AG-610 BLOOD GLUCOSE MONITORING SYSTEM

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

FULLY AUTOMATIC ELECTRONIC BLOOD PRESSURE MONITOR MODEL MD-534

FDA 510(k)

FDA Class 2 ·Cardiovascular

FULLY AUTOMATIC ELECTRONIC BLOOD PRESSURE MONITOR MODEL KD-513

FDA 510(k)

FDA Class 2 ·Cardiovascular

FLARE Single-Use Surgical Laser Fiber

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

Disposable Surgical Gown Rk-3011C

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

Digital Blood Pressure Monitor WBP Series, including: WBP101, WBP102, WBP103, WBP104, WBP105, WBP106, WBP107

FDA 510(k)

FDA Class 2 ·Cardiovascular

IPL Hair Removal Device (YT01,YT02,YT03,YT04)

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

U1 HIP SYSTEM

FDA 510(k)

FDA Class 2 ·Orthopedic

Dental Porcelain Powder

FDA 510(k)

FDA Class 2 ·Dental