Endoscopic Water Pump

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

Single-Use Digital Flexible Ureteroscope (PUR12-1, PUR12-2, PUR12-3, PUR12-4, PUR12-5, PUR12-6, PUR12-S, PUR12-S1, PUR12-S2)

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

Air Compression Leg Massager (UM605, UM606, UM607, UM608,UM609,UM610, UM611, UM617)

FDA 510(k)

FDA Class 2 ·Physical Medicine

Wireless TENS & EMS Unit

FDA 510(k)

FDA Class 2 ·Physical Medicine

SURGICAL GOWN

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

Bipolar Coagulation Foreceps

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

Locking device

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

AXS Catalyst 7 Distal Access Catheter (068 x 115cm, 068 x 125cm, 068 x 132cm)

FDA 510(k)

FDA Class 2 ·Cardiovascular

OmniWire Pressure Guide Wire, 185 cm Straight Tip, OmniWire Pressure Guide Wire, 185 cm J-Tip

FDA 510(k)

FDA Class 2 ·Cardiovascular

6MP Color LCD Monitor (C61W+)

FDA 510(k)

FDA Class 2 ·Radiology

Trevo NXT ProVue Retriever

FDA 510(k)

FDA Class 2 ·Neurology

Bronchoscope System

FDA 510(k)

FDA Class 2 ·Ear, Nose, Throat

Navigator (FMNVG15); Navigator XL (FMNVX06)

FDA 510(k)

FDA Class 2 ·Physical Medicine

Upper Arm Electronic Blood Pressure Monitor (U87Y series (models including U80Y, U81Y, U82Y,U83Y,U86Y U80N, U81NH), U86E series (including U82E, U80E, U80EH, U81E, U83E, U85E, U80L, U87E ), U81X series (including U81X, U80X, U82X, U83X, U81D, U82D, U83D, U81RH, U82RH) and U83Z series (including U83Z, U80Z, U81Z, U82Z, U85Z, U86Z and U87Z))

FDA 510(k)

FDA Class 2 ·Cardiovascular

NON-CONTACT INFRARED THERMOMETER

FDA 510(k)

FDA Class 2 ·General Hospital

AXS Catalyst Distal Access Catheter 068 x 115cm, AXS Catalyst Distal Access Catheter 068 x 125cm, AXS Catalyst Distal Access Catheter 068 x 132cm

FDA 510(k)

FDA Class 2 ·Cardiovascular

EZFIT DIGITAL HEATING TENS (MODEL NO.: HR-661/UC-101)

FDA 510(k)

FDA Class 2 ·Neurology

Hemoclip

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

ANT INFLATION DEVICE/ANT INFLATION DEVICE COMPACT PACK

FDA 510(k)

FDA Class 2 ·Cardiovascular

IRENE Thoracolumbar Fixation System

FDA 510(k)

FDA Class 2 ·Orthopedic