EP15 SOFTWARE MODULE, EP25 SOFTWARE MODULE

FDA 510(k)

FDA Class 2 ·Ear, Nose, Throat

KIDScore D3

FDA 510(k)

FDA Class 2 ·Obstetrics/Gynecology

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

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

Ambu aScope 5 Broncho HD 5.6/2.8, Ambu aScope 5 Broncho HD 5.0/2.2, Ambu aBox 2

FDA 510(k)

FDA Class 2 ·Ear, Nose, Throat

ITC HEARING AID CLUB MODEL LM50

FDA 510(k)

FDA Class 1 ·Ear, Nose, Throat

Frax 1550 for Ellipse Nordlys/ Ellipse Nordlys+, Ellipse Sirius, Ellipse Infinity, Ellipse Mjolner, Ellipse Nordlys Ultra

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

CLICK-ON

FDA 510(k)

FDA Class 2 ·General Hospital

ELLIPSE 12PL, MODEL 9ESL7228

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

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

AQT90 FLEX CKMB TEST KIT, AQT90 FLEX LQC MULTI-CHECK, LEVELS 1-3, AQT90 FLEX CKMB CAL CARTRIDGE

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

RTX3320PSTN WIRELESS TELEHEALTH GATEWAY

FDA 510(k)

FDA Class 2 ·Cardiovascular

NICU V'02

FDA 510(k)

FDA Class 2 ·Anesthesiology

35/CD CINECONVERTER

FDA 510(k)

FDA Class 2 ·Radiology

AQT90 FLEX Myo Test Kit, AQT90 FLEX CKMB Test Kit, AQT90 FLEX

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

ELLIPSE JUVIA, MODEL 9EJU7465

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

MiniMed Mio Advance infusion set

FDA 510(k)

FDA Class 2 ·General Hospital

Ambu aScope 4 RhinoLaryngo Slim

FDA 510(k)

FDA Class 2 ·Ear, Nose, Throat

3Shape Abutment Designer Software

FDA 510(k)

FDA Class 2 ·Dental

Gunther Tulip Vena Cava Filter Set for Femoral Vein Approach, Gunther Tulip Vena Cava Filter Set for Jugular Vein Approach, Gunther Tulip Vena Cava Filter Set for Femoral and Jugular Vein Approach

FDA 510(k)

FDA Class 2 ·Cardiovascular

ULTRASOUND SCANNER FLEX FOCUS 1202

FDA 510(k)

FDA Class 2 ·Radiology