OnX Tough

FDA 510(k)

FDA Class 2 ·Dental

ONX Large External Fixation System

FDA 510(k)

FDA Class 2 ·Orthopedic

CHORD-X PRE-MEASURED LOOPS FOR MITRAL CHORDAL REPLACEMENT

FDA 510(k)

FDA Class 2 ·Cardiovascular

ARCHITECT ROMA

FDA 510(k)

FDA Class 2 ·Obstetrics/Gynecology

OVA1 Next Generation

FDA 510(k)

FDA Class 2 ·Obstetrics/Gynecology

OVA1 TEST

FDA 510(k)

FDA Class 2 ·Obstetrics/Gynecology

ROMA (HE4 EIA + ARCHITECT CA 125 II)

FDA 510(k)

FDA Class 2 ·Obstetrics/Gynecology

Lumipulse G ROMA

FDA 510(k)

FDA Class 2 ·Obstetrics/Gynecology

ROMA Calculation Tool Using Elecsys Assays

FDA 510(k)

FDA Class 2 ·Obstetrics/Gynecology

Ovarian Adnexal Mass Assessment Score Test System

FDA classification

FDA Class 2 ·Ovarian Adnexal Mass Assessment Score Test System

Viz ANEURYSM, Viz ANX

FDA 510(k)

FDA Class 2 ·Radiology

BNX FINE NEEDLE ASPIRATION SYSTEM

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

BNX Fine Needle Aspiration System

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

NEXUS HEMORRHOID LIGATOR

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

CMFlexTM

FDA 510(k)

FDA Class 2 ·Dental

HOME-AWAY SYSTEM, MODEL 1041

FDA 510(k)

FDA Class 2 ·Anesthesiology

NaviCam Xpress Stomach System, NaviCam Xpress System

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

NaviCam Xpress Stomach Capsule Endoscope System (NaviCam Xpress Stomach System) with NaviCam Capsule and NaviCam Tether

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

MotiliCap GI Monitoring System

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

NaviCam Capsule Endoscope System with NaviCam Stomach Capsule and NaviCam Tether, NaviCam Xpress Stomach Capsule Endoscope System (NaviCam Xpress Stomach System) with NaviCam Stomach Capsule and NaviCam Tether

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology