Catheters, Transluminal Coronary Angioplasty, Percutaneous

FDA Pre-Market Approval

FDA Class 2 ·CROSS SAIL CORONARY DILATATION CATHETER

LA MONT VIDEO PATIENT MONITORING SYSTEM

FDA 510(k)

FDA Class 2 ·Neurology

Geon (S2) Nasal Aspirator

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

ARGOS

FDA 510(k)

FDA Class 2 ·Neurology

Stryker Q Guidance System with Cranial Guidance Software, CranialMask Tracker and Microscope Tracker, Passive Optical Navigation Instruments, Mayfield Base with Articulating Arm, and Navigated Biopsy Needle, Electromagnetic Navigation Instruments, Precision Targeting System

FDA 510(k)

FDA Class 2 ·Neurology

STRYKER NAV3I PLATFORM

FDA 510(k)

FDA Class 2 ·Neurology

neuromate Gen III

FDA 510(k)

FDA Class 2 ·Neurology

SmartFrame OR

FDA 510(k)

FDA Class 2 ·Neurology

MODIFICATION TO FLOUROLAB PLUS

FDA 510(k)

FDA Class 2 ·Neurology

NAVIGUS UNIBODY FIDUCIAL MARKER SYSTEM, MODEL FM-4000

FDA 510(k)

FDA Class 2 ·Neurology

Cranial EM System

FDA 510(k)

FDA Class 2 ·Neurology

NaviNetics Reusable Stereotactic System (NN1000)

FDA 510(k)

FDA Class 2 ·Neurology

EBI ACUMEN SURGICAL NAVIGATION SYSTEM

FDA 510(k)

FDA Class 2 ·Neurology

STEALTHSTATION TREATMENT GUIDANCE PLATFORM

FDA 510(k)

FDA Class 2 ·Neurology

NaviENT

FDA 510(k)

FDA Class 2 ·Neurology

Disposable Brain Biopsy Needle 2.0

FDA 510(k)

FDA Class 2 ·Neurology

Stryker Universal Neuro III System: UN III AXS Screw, UN III AXS Screwdriver Blade

FDA 510(k)

FDA Class 2 ·Neurology

Neural Navigator

FDA 510(k)

FDA Class 2 ·Neurology

CASS SYSTEM

FDA 510(k)

FDA Class 2 ·Neurology

STRYKER NAVIGATION SYSTEM - ENT MODULE

FDA 510(k)

FDA Class 2 ·Neurology