NeuroVention Cranial Fixation System, NuCrani Plates, KTC Burr Hole Cover, DC Plate

FDA 510(k)

FDA Class 2 ·Neurology

Corelink Navigation Instruments

FDA 510(k)

FDA Class 2 ·Neurology

ThermoChem HT-2000 System and Intraperitoneal Hyperthermia (IPH) Procedure Kit (HT-2000)

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

Quantra Hemostasis Analyzer

FDA 510(k)

FDA Class 2 ·Hematology

BRAND NAME 1-STEP PREGNANCY TEST-MAY BE MARKETED UNDER FIRST RESPONSE, ANSWER, OR OTHER BRAND NAMES

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

MODIFICATION TO GELBFISH VASCULAR DILATORS

FDA 510(k)

FDA Class 2 ·Cardiovascular

NEUROSYSTEMS 1TM MONITOR

FDA 510(k)

FDA Class 2 ·Neurology

MCOMPASS ANORECTAL MANOMETRY SYSTEM

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

ELECTRODE, FLEXIBLE SUCTION COAGULATOR

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

POLARIS SPINAL SYSTEM -TRANSLATION SCREW

FDA 510(k)

FDA Class 2 ·Orthopedic

Osseoflex SB Straight Balloon, 10g/4ml, Osseoflex SB Straight Balloon, 10g/2ml

FDA 510(k)

FDA Class 2 ·Orthopedic

UCG-BETA SLIDE

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

APRO 70 Swift Catheter

FDA 510(k)

FDA Class 2 ·Cardiovascular

MODIFICATION TO CELLSEARCH CIRCULATING TUMOR CELL KIT

FDA 510(k)

FDA Class 2 ·Immunology

CubeVue

FDA 510(k)

FDA Class 2 ·Radiology

Nanovis Intervertebral Body Fusion System and Forticore(R)

FDA 510(k)

FDA Class 2 ·Orthopedic

Harrier-SA Lumbar Interbody System

FDA 510(k)

FDA Class 2 ·Orthopedic

STAT PACS PICTURE ARCHIVING & COMMUNICATION SYSTEM (PACS)

FDA 510(k)

FDA Class 2 ·Radiology

REMEDY Acetabular Cup

FDA 510(k)

FDA Class 2 ·Orthopedic

Passion Natural Water Based Lubricant

FDA 510(k)

FDA Class 2 ·Obstetrics/Gynecology