KONICA LASER IMAGER, DRYPRO MODEL 751/752

FDA 510(k)

FDA Class 2 ·Radiology

ELECTRONIC DIGITAL BLOOD PRESSURE MONITOR

FDA 510(k)

FDA Class 2 ·Cardiovascular

RadiForce RX270

FDA 510(k)

FDA Class 2 ·Radiology

Processor VP-7000, Light Source BL-7000X, Image Processing Unit EX-0

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

JMS APHERESIS NEEDLE

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

CLEARFIL CERAMIC PRIMER PLUS, CLEARFIL CERAMIC PRIMER PLUS (Trial)

FDA 510(k)

FDA Class 2 ·Dental

FUJIFILM Ultrasonic Endoscope

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

Vantage Galan 3T, MRT-3020, V8.0 with AiCE Reconstruction Processing Unit for MR

FDA 510(k)

FDA Class 2 ·Radiology

Aquilion Lightning (TSX-035A/2, V7.0)

FDA 510(k)

FDA Class 2 ·Radiology

OLYMPUS URF-P6/P6R

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

Deep Learning Image Reconstruction

FDA 510(k)

FDA Class 2 ·Radiology

CGBA-032A, Aquilion PRIME Self-Propelled Scan Base Kit for IVR-CT

FDA 510(k)

FDA Class 2 ·Radiology

CLIMB MAMMOGRAPHY VIEWER SOFTWARE

FDA 510(k)

FDA Class 2 ·Radiology

Surgical Face Masks (Ear loops and Tie-on)

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

GLUCOCARD® W onyx Blood Glucose Monitoring System

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

Single Use Grasping Forceps FG-214P, Single Use Grasping Forceps FG-220P, Single Use Grasping Forceps FG-226C, Single Use Grasping Forceps FG-232L, Single Use Grasping Forceps FG-804L

FDA 510(k)

FDA Class 2 ·Ear, Nose, Throat

SSS, MODEL 1072001 (STANDARD 4-HOLE MODEL) & 1072002 (STANDARD 2-HOLE MODEL)

FDA 510(k)

FDA Class 2 ·Dental

Vantage Galan 3T, MRT-3020/A9, V5.0

FDA 510(k)

FDA Class 2 ·Radiology

FUJIFILM Endoscope Model EC-760S-V/L

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

ARGOS

FDA 510(k)

FDA Class 2 ·Ophthalmic