OSTEON II

FDA 510(k)

FDA Class 2 ·Dental

OSSEOFUSE DENTAL IMPLANT SYSTEM

FDA 510(k)

FDA Class 2 ·Dental

MiroCam Capsule Endoscope System

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

RCT800

FDA 510(k)

FDA Class 2 ·Radiology

GE333 Blood Glucose Monitoring System

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

Deep Learning Image Reconstruction

FDA 510(k)

FDA Class 2 ·Radiology

EXPD 4357; EXPD 4357P

FDA 510(k)

FDA Class 2 ·Radiology

SPUR ADULT WITH OPEN RESERVOIR SYSTEM

FDA 510(k)

FDA Class 2 ·Anesthesiology

LOW PROFILE GASTROSTOMY FEEDING TUBE OR GASTROTOMEY BUTTON

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

CT3000Pro

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

ARIX Ankle System

FDA 510(k)

FDA Class 2 ·Orthopedic

VORTRAN Cuff Inflator (VCI)

FDA 510(k)

FDA Class 2 ·Anesthesiology

BioCardia 8F Morph DNA Deflectable Guide Catheter

FDA 510(k)

FDA Class 2 ·Cardiovascular

DAHEDI INSULIN INFUSION PUMP

FDA 510(k)

FDA Class 2 ·General Hospital

GORE-TEX(R) STRETCH VASCULAR GRAFT

FDA 510(k)

FDA Class 2 ·Cardiovascular

Niti-S Biliary Speed D Stent

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

rainbow MCT

FDA 510(k)

FDA Class 2 ·Radiology

AT-Patch (ATP-C130/ATP-C70)

FDA 510(k)

FDA Class 2 ·Cardiovascular

STERNGOLD 2.2MM ANGLES MICRO ERA DENTAL IMPLANT SYSTEM

FDA 510(k)

FDA Class 2 ·Dental

MICRUS MICROCOLI SYSTEM, DELTAPLUSH, MODELS CPL, DPL

FDA 510(k)

FDA Class 2 ·Neurology