LUMINELLE DTx System

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

WARMAIR SYSTEM

FDA 510(k)

FDA Class 2 ·Cardiovascular

ENDOSCOPIC DIAGNOSTIC & TREATMENT SYSTEM (MODIFICATION)

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

THERMO-K

FDA 510(k)

FDA Class 2 ·Cardiovascular

OPT-SHIELD AIR, SUPINE; OPT-SHIELD, LITHOTOMY

FDA 510(k)

FDA Class 2 ·Cardiovascular

ECN ELECTRONIC VIDEO CYSTONEPHROSCOPE

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

Vesair 0 degree Cystoscope, Vesair 30 degree Long Cystoscope, Vesair 70 degree Long Cystoscope,Vesair 30 degree Cystoscope,Vesair 70 degree Cystoscope

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

POINT LOCATOR STIMULATOR

FDA 510(k)

FDA Class 2 ·General Hospital

VersaVue Single-Use Flexible Cystoscope, VersaVue Tablet, and VersaVue Video Box

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

BAIR PAWS TEMPERATURE MANAGEMENT SYSTEM MODEL 850

FDA 510(k)

FDA Class 2 ·Cardiovascular

ALLON 2001 VERSION 5

FDA 510(k)

FDA Class 2 ·Cardiovascular

COVIDIEN WARMTOUCH CONVECTIVE WARMING UNIT

FDA 510(k)

FDA Class 2 ·Cardiovascular

Ambu® aScope™ 5 Cysto HD (Standard Deflection); Ambu® aScope™ 5 Cysto HD (Reverse Deflection)

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

MODIFICATION TO:BAIR HUGGER TEMPERATURE MANAGEMENT SYSTEMS

FDA 510(k)

FDA Class 2 ·Cardiovascular

Ambu® aScope™ 5 Cysto HD (Standard Deflection); Ambu® aScope™ 5 Cysto HD (Reverse Deflection); Ambu® aBox™ 2

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

ELECTRONIC CONTROL UNIT

FDA 510(k)

FDA Class 2 ·Cardiovascular

TC-1000, TC-1050 SYSTEM

FDA 510(k)

FDA Class 2 ·Cardiovascular

VITAHEAT PATIENT WARMING SYSTEM

FDA 510(k)

FDA Class 2 ·Cardiovascular

STERIS Patient Warming System

FDA 510(k)

FDA Class 2 ·Cardiovascular

PENTAX CYSTOFIBERSCOPE, MODEL FCY-15P

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology