DUAL LUMEN NEEDLES

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

COLORGENE DNA HYBRIDIZATION TEST CMV CONFIRMATION

FDA 510(k)

FDA Class 2 ·Microbiology

INSALL-BURSTEIN II

FDA 510(k)

FDA Class 2 ·Orthopedic

JET BLUE BITE

FDA 510(k)

FDA Class 2 ·Dental

BEDSIDE PATIENT MONITOR W/MODULES

FDA 510(k)

FDA Class 2 ·Cardiovascular

GOLNIT Non-aborbable PTFE Surgical Suture

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

RASL Repair Kit

FDA 510(k)

FDA Class 2 ·Orthopedic

SURGASSIST COMPUTER MEDIATED LINEAR CUTTER DIGITAL LOADING UNITS, 30 MM, 55 MM, 75 MM

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

NET Brand Small Fragment and Large Fragment Osteosynthesis Plating System, NET Brand of DHS/DCS Plating System

FDA 510(k)

FDA Class 2 ·Orthopedic

MEDRELIEF SE SERIES, MODELS SE-50, SE-100, SE-200, SE-300

FDA 510(k)

FDA Class 2 ·Physical Medicine

CLEARFIL AP-X

FDA 510(k)

FDA Class 2 ·Dental

AUXEIN BRAND OF Bone Plates and Bone Screws & AUXEIN Brand of DCS Plate System AUXEIN brand of Locking Plates and Locking Screws

FDA 510(k)

FDA Class 2 ·Orthopedic

ENTERAL PUMP SET W/ENTERAL SPIKE FOR USE W/FEED PU

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

MD.ai Viewer

FDA 510(k)

FDA Class 2 ·Radiology

GLYCOMARK

FDA 510(k)

FDA Class 2 ·Hematology

BIO SCAN-BG(TM

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

AERODR SYSTEM

FDA 510(k)

FDA Class 2 ·Radiology

CreoDent Solidex Customized Abutment

FDA 510(k)

FDA Class 2 ·Dental

MilkMate Breast Pump (A0006); MilkMate Kit (sterile, single-use only), 21 mm breast shield (A0005-21); MilkMate Kit (sterile, single-use only), 24 mm breast shield (A0005-24)

FDA 510(k)

FDA Class 2 ·Obstetrics/Gynecology

HENRY SCHEIN SURGICAL MASK

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery