ONEDOSE PATIENT DOSIMETRY SYSTEM

FDA 510(k)

FDA Class 2 ·Radiology

Luminelle DTx Hysteroscopy System

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

UNOLOK PLUS INFUSION SET AND VAKU-8 PLUS BLOOD COLLECTION SET

FDA 510(k)

FDA Class 2 ·General Hospital

LessRay with Tracking

FDA 510(k)

FDA Class 2 ·Radiology

OPTIVIA HYSTEROSCOPIC INTRODUCER, OPTIVIA STEERABLE WORKING CHANNEL

FDA 510(k)

FDA Class 2 ·Obstetrics/Gynecology

Sonablate

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

UROPUMP* FLUID MANAGEMENT SYSTEM

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

CHIBA/FRANSEEN/WESTCOTT/SPINAL STYLE NEEDLES

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

HERCULES 3 STAGE WIRE GUIDED DILATION BALLOON

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

Arrow® Nitinol Wire

FDA 510(k)

FDA Class 2 ·Cardiovascular

TELEFLEX ISIS HVT TRACHEAL TUBE, CUFFED, WITH SUBGLOTTIC SECRETION SUCTION PORT

FDA 510(k)

FDA Class 2 ·Anesthesiology

MDA D-DIMER

FDA 510(k)

FDA Class 2 ·Hematology

COAG-A-MATE XC/XC PLUS VERSION D.00 SOFTWARE

FDA 510(k)

FDA Class 2 ·Hematology

Rusch Flocath Hydrophilic Intermittent Catheter, Rusch MMG Hydrophilic Intermittent Catheter

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

AFT PROXIMAL HUMERUS FRACTURE PLATE

FDA 510(k)

FDA Class 2 ·Orthopedic

VITEK 2 AST-ST CEFOTAXIME

FDA 510(k)

FDA Class 2 ·Microbiology

RELI REDIDIOX Dyed, RELI REDIDIOX, RELI REDIDIOX Undyed

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

Sheridan Spiral-Flex Endotracheal Tubes

FDA 510(k)

FDA Class 2 ·Anesthesiology

Follicle Clarity

FDA 510(k)

FDA Class 2 ·Radiology

JOBST ATHROMBIC PUMP/SLEEVE

FDA 510(k)

FDA Class 2 ·Cardiovascular