IMRIS ONCOLOGY PACKAGE

FDA 510(k)

FDA Class 2 ·Radiology

BLUE LINE ULTRA SUCTIONAID TRACHEOSTOMY TUBE

FDA 510(k)

FDA Class 2 ·Anesthesiology

Envision 3D: Image Guidance System

FDA 510(k)

FDA Class 2 ·Neurology

FLASH EVD System (10-0002)

FDA 510(k)

FDA Class 2 ·Neurology

7D Surgical System

FDA 510(k)

FDA Class 2 ·Neurology

Bravo G4 Chamber Autoclave

FDA 510(k)

FDA Class 2 ·General Hospital

7D Registration Frame, 7D Flex Iliac Pin Connector, 7D Pin Guide Block, 7D 3.2 mm Steinmann Pin, 7D Iliac Crest Pin Chuck & Key

FDA 510(k)

FDA Class 2 ·Neurology

HIPPOCRAT ELECTRONIC STETHOSCOPE, MODEL DR300; SOUNDS EASY AUSCULTATION SOFTWARE

FDA 510(k)

FDA Class 2 ·Cardiovascular

STATIM 7000 (WITHOUT USB PORT), MODEL 01-702100, STATIM 7000 (WITH USB PORT), MODEL 01-702101

FDA 510(k)

FDA Class 2 ·General Hospital

STATCLAVE G4 Chamber Autoclave

FDA 510(k)

FDA Class 2 ·General Hospital

POLYSIL (VINYL POLYSILOXAN IMPRESSION MATERIAL)

FDA 510(k)

FDA Class 2 ·Dental

BRAVO AUTOCLAVE, MODELS 17, 17V AND 21V

FDA 510(k)

FDA Class 2 ·General Hospital

Small Volume 0.2mL Syringe

FDA 510(k)

FDA Class 2 ·General Hospital

7D Surgical System

FDA 510(k)

FDA Class 2 ·Neurology

Foresight Intracardiac Echocardiography (ICE) System

FDA 510(k)

FDA Class 2 ·Cardiovascular

WALLACE (SURE VIEW) EMBRYO REPLACEMENT CATHETER AND TRIAL TRANSFER CATHETER

FDA 510(k)

FDA Class 2 ·Obstetrics/Gynecology

STATClave G4 Chamber Autoclave

FDA 510(k)

FDA Class 2 ·General Hospital

SALUS - Hygiene Instrument Reprocessing Container

FDA 510(k)

FDA Class 2 ·General Hospital

7D Surgical System

FDA 510(k)

FDA Class 2 ·Neurology

7D Surgical FlashLock 1, 7D Surgical Flex Rod Connector - 5.5 mm - 150 mm, 7D Surgical Flex Array

FDA 510(k)

FDA Class 2 ·Neurology