Resona R9/ Resona R9 Exp/ Resona R9 Pro/ Resona R9S/ Nuewa R9/ Nuewa R9 Exp Diagnostic Ultrasound Sysem, Nuewa R9 Pro/ Nuewa R9S/ Resona 7/ Resona 7CV/Resona 7EXP/Resona 7S/ Resona 70B Diagnostic Ultrasound System, Resona 7PRO/Imagyn 7/ Resona Y/Resona R9W/Resona R7W Nuewa R9W/Nuewa R7W Diagnostic Ultrasound System

FDA 510(k)

FDA Class 2 ·Radiology

HUDSON 2020, 2040, 2060,ULTRASOUND SCANNERS

FDA 510(k)

FDA Class 2 ·Radiology

DIGITAL FLAT PANEL X-RAY DETECTOR/1417PGA

FDA 510(k)

FDA Class 2 ·Radiology

INFLOW INTRAURETHRAL VALVE-PUMP

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

MESH GPS - LARGE, SMALL, SM, SM SMALL

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

RESTORIS POROUS PARTIAL KNEE SYSTEM

FDA 510(k)

FDA Class 2 ·Orthopedic

JOURNEY II UK™ and ENGAGE™ Cementless Partial Knee System

FDA 510(k)

FDA Class 2 ·Orthopedic

Engage™ Partial Knee System

FDA 510(k)

FDA Class 2 ·Orthopedic

HLM TUBING SET WITH BIOLINE COATING

FDA 510(k)

FDA Class 2 ·Cardiovascular

PUMP TUBING WITH X-COATING

FDA 510(k)

FDA Class 2 ·Cardiovascular

COBE SMARXT TUBING AND CONNECTORS

FDA 510(k)

FDA Class 2 ·Cardiovascular

GENTLE HEADER

FDA 510(k)

FDA Class 2 ·Cardiovascular

SARNS TEMPERATURE PROBE AND CONNECTOR

FDA 510(k)

FDA Class 2 ·Cardiovascular

CARDIOPULMONARY BYPASS PUMP TUBING - 1/4 INCH TUBING, CARDIOPULMONARY BYPASS PUMP TUBING - 3/8 INCH TUBING

FDA 510(k)

FDA Class 2 ·Cardiovascular

CARDIO-PAK BASIC PUMP PACK

FDA 510(k)

FDA Class 2 ·Cardiovascular

PUMP TUBING

FDA 510(k)

FDA Class 2 ·Cardiovascular

SMARxT Tubing and Connectors

FDA 510(k)

FDA Class 2 ·Cardiovascular

AngioVac Circuit

FDA 510(k)

FDA Class 2 ·Cardiovascular

VORTEX MEDICAL ANGIOVAC CARDIOPULMONARY BYPASS CIRCUIT

FDA 510(k)

FDA Class 2 ·Cardiovascular

TYGON TUBING

FDA 510(k)

FDA Class 2 ·Cardiovascular