OCELOT SYSTEM

FDA 510(k)

FDA Class 2 ·Cardiovascular

PowerWire Radiofrequency Guidewire Kit

FDA 510(k)

FDA Class 2 ·Cardiovascular

Ultra ICE Plus 9 MHz IntraCardiac Echo Catheter(eDFU), Ultra ICE Plus 9 MHz IntraCardiac Echo Catheter (Paper DFU)

FDA 510(k)

FDA Class 2 ·Cardiovascular

ELECTRODE FOR URINARY INCONTINENCE

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

JETi Hydrodynamic Thrombectomy System

FDA 510(k)

FDA Class 2 ·Cardiovascular

Essence 55SP Large Monitor System

FDA 510(k)

FDA Class 2 ·Cardiovascular

UBI MAGIWEL(TM) ANA QUANTITATIVE

FDA 510(k)

FDA Class 2 ·Immunology

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

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

Electronic Pulse Stimulator Model: PL-029K12 and PL-029K13

FDA 510(k)

FDA Class 2 ·Neurology

Locking device

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

Ultrasound Stimulator

FDA 510(k)

FDA Class 2 ·Physical Medicine

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