ECLIPSE TREATMENT PLANNING SYSTEM

FDA 510(k)

FDA Class 2 ·Radiology

THE VISUALIZED ENDOTRACHEAL TUBE SYSTEM OR VETT SYSTEM

FDA 510(k)

FDA Class 2 ·Anesthesiology

HITACHI CLINICAL ANALYZER S TEST REAGENT CARTRIDGES FOR LD AND AMY

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

EMIT QST ACETAMINOPHEN ASSAY

FDA 510(k)

FDA Class 2 ·Clinical Toxicology

ENVISION ARTHROSCOPY VISUALIZATION SYSTEM

FDA 510(k)

FDA Class 2 ·Orthopedic

Titanium Fletcher-Style Applicator Set Defined Geometry; Smit Cervical Sleeve

FDA 510(k)

FDA Class 2 ·Radiology

JOULE MULTI-PLATFORM SYSTEM

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

HIGH-DEFINITION 120 MULTILEAF COLLIMATOR (HD120 MLC)

FDA 510(k)

FDA Class 2 ·Radiology

TRUE BEAM, TRUE BEAM STX, EDGE

FDA 510(k)

FDA Class 2 ·Radiology

DISPOSABLE SUPPLIES KIT FOR PEA PROCEDURE

FDA 510(k)

FDA Class 2 ·Ophthalmic

COHERENT VERSAPULSE(TM) 2.1XE/2.1L HOLMI SURG LASE

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

BRAVOS Afterloader Family: BRAVOS Afterloader System, Transfer Guide Tubes and Length Assessment Device

FDA 510(k)

FDA Class 2 ·Radiology

VitalBeam

FDA 510(k)

FDA Class 2 ·Radiology

TrueBeam, TrueBeam STx, Edge, VitalBeam

FDA 510(k)

FDA Class 2 ·Radiology

SILENT NIGHT I

FDA 510(k)

FDA Class 2 ·Anesthesiology

Halcyon, Ethos Radiotherapy System

FDA 510(k)

FDA Class 2 ·Radiology

ECLIPSE 2100

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

REVISED LABELING FOR SYVA METHAQUALONE ASSAYS

FDA 510(k)

FDA Class 2 ·Clinical Toxicology

RTHawk, HeartVista Cardiac Package

FDA 510(k)

FDA Class 2 ·Radiology

OSSEODENT SURGICAL KIT

FDA 510(k)

FDA Class 2 ·Dental