DOSE VOLUME HISTOGRAM (DVH) EVALUATOR

FDA 510(k)

FDA Class 2 ·Radiology

AMID STAPLER

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

OsteoRemedies Hip Spacer System

FDA 510(k)

FDA Class 2 ·Orthopedic

WITTMANN PATCH

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

X-ray Imaging System for the McLaren Proton Treatment System

FDA 510(k)

FDA Class 2 ·Radiology

BREAST VOLUME NAVIGATOR

FDA 510(k)

FDA Class 2 ·Radiology

K7 LUMBAR SPACERS

FDA 510(k)

FDA Class 2 ·Orthopedic

INNOCURE IMRT FILTER (COMPENSATORS)

FDA 510(k)

FDA Class 2 ·Radiology

StimSox(TM) System

FDA 510(k)

FDA Class 2 ·Physical Medicine

VIROGEN RUBELLA MICROTITER TEST

FDA 510(k)

FDA Class 2 ·Microbiology

ALARA Neuro Access Kit

FDA 510(k)

FDA Class 2 ·Ear, Nose, Throat

COMPLETE CONTROL System Gen2

FDA 510(k)

FDA Class 2 ·Neurology

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