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

NaviCam Small Bowel Capsule Endoscopy System with NaviCam SB Capsule and NaviCam Tether

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

NaviCam Xpress Stomach System

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

binx io CT/NG Assay and binx io CT/NG System

FDA 510(k)

FDA Class 2 ·Microbiology

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

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

IntraMarX 3D Radiopaque Marker

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

NaviCam Capsule Endoscope System with NaviCam Stomach Capsule

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

IntraMarX Radiopaque Markers

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

Hepatitis A Test (Antibody And Igm Antibody)

FDA Pre-Market Approval

FDA Class 2 ·IMX HAVAB

MIAMI-SUNNY

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

BraidE Embolization Assist Device

FDA 510(k)

FDA Class 2 ·Cardiovascular

TIDI BRAND STERILIZATION WRAP

FDA 510(k)

FDA Class 2 ·General Hospital

HANAROSTENT Benefit Biliary (NNN)

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

BODYTRONIC 200

FDA 510(k)

FDA Class 2 ·Cardiovascular

HANAROSTENT LowAx Colon/Rectum (NNN), HANAROSTENT LowAx Duodenum/Pylorus (NNN)

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

REVERSE CUTTING CANNULATED CANCELLOUS BONE SCREW

FDA 510(k)

FDA Class 2 ·Orthopedic

HANAROSTENT Esophagus (CCC), HANAROSTENT Esophagus (NCN)

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

GV3000 PHACOEMULSIFIER/FRAGMENTER

FDA 510(k)

FDA Class 2 ·Ophthalmic

Drivewire 24 Guidewire

FDA 510(k)

FDA Class 2 ·Cardiovascular