RADIOCAMERAS EXTRACRANIAL SYSTEM

FDA 510(k)

FDA Class 2 ·Radiology

QLASER SYSTEM

FDA 510(k)

FDA Class 2 ·Physical Medicine

GAMCATH HIGH FLOW DOLPHIN MS-GDHC-1315 A; AND MS-GDHC-1315J A, GAMCATH HIGH FLOW DOLPHIN MS-GDHC-1320 A; AND MS-GDHC-132

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

CYCLO-BRUSH

FDA 510(k)

FDA Class 2 ·Obstetrics/Gynecology

NEW COBE SATURATION/HEMATOCRIT MONITOR

FDA 510(k)

FDA Class 2 ·Hematology

HYFRECATOR 2000 REUSABLE HAND-SWITCHING ACCESSORY HANDPIECE/FOOT-SWITCHING ACCESSORY HANDPIECE, HYFRECATOR PLUS REUSABL

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

BONE PLATE; BONE SCREW

FDA 510(k)

FDA Class 2 ·Dental

SUREFIT DUAL DISPERSIVE ELECTRODE

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

BEDSIDE RESPIRATORY PATIENT MONITORING SYSTEM, BEDSIDE RESPIRATORY PATIENT MONITORING SYSTEM WITH RESPIRATION RATE SOFTW

FDA 510(k)

FDA Class 2 ·Cardiovascular

ECHOTECH EASY 3D FAMILY, ECHOTECH 3D FREESCAN, ECHOTECH EASYARCHIVE, ECHOTECH QUANTICON, ECHOTECH EASYSTRESS

FDA 510(k)

FDA Class 2 ·Radiology

REAADS ANTI-CARDIOLIPIN IGG/IGM SEMI-QUANTITATIVE TEST KIT, MODEL 023-001

FDA 510(k)

FDA Class 2 ·Immunology

T UPTAKE ENZYME IMMUNOASSAY CRIMPED TUBE KIT

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

STELTHSTATION WIRELESS SURGEON MOUSE

FDA 510(k)

FDA Class 2 ·Neurology

COBE CENTRY 2 BICART OPTION KIT

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

MIKADO AC 405

FDA 510(k)

FDA Class 2 ·Anesthesiology

THE GENERIC OXYGEN CONCENTRATOR

FDA 510(k)

FDA Class 2 ·Anesthesiology

Phantom Small Bone Intramedullary Nail System

FDA 510(k)

FDA Class 2 ·Orthopedic

MODIFICATION TO: ACCUFUSER, ACCUFUSER PLUS, STANDARD PROCEDURE KITS

FDA 510(k)

FDA Class 2 ·General Hospital

ARCTIC SUN TEMPERATURE MANAGEMENT SYSTEM, MODEL 100 CONTROL UNIT AND PATIENT ENERGY TRANSFER PADS

FDA 510(k)

FDA Class 2 ·Cardiovascular

PORTABLE OXYGEN GENERATOR

FDA 510(k)

FDA Class 2 ·Anesthesiology