CROSSLEAD Tracker

FDA 510(k)

FDA Class 2 ·Cardiovascular

RX NC Takeru PTCA Balloon Dilatation Catheter

FDA 510(k)

FDA Class 2 ·Cardiovascular

Revolution Ascend

FDA 510(k)

FDA Class 2 ·Radiology

Aquilion Precision (TSX-304A/1 and /2) V8.8 with AiCE

FDA 510(k)

FDA Class 2 ·Radiology

Blood Tubing Lines for Hemodialysis AL Series (Archloop), Blood Tubing Lines for Hemodialysis C18 Series

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

OSTEOTRANS-OT SCREW

FDA 510(k)

FDA Class 2 ·Orthopedic

MODIFICATION TO KOWA NONMYD ALPHA-DIII

FDA 510(k)

FDA Class 2 ·Ophthalmic

REGIUS CONSOLE CS-2000 AND REGIUS CONSOLE CS-3000, MEDICAL IMAGE PROCESSING WORKSTATION

FDA 510(k)

FDA Class 2 ·Radiology

Olympus Small Intestinal Capsule Endoscope System

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

Strip, Dialysate, Ph, Bicarbonate, Glucose, Acid, Indicator

FDA classification

FDA Class 2 ·Strip, Dialysate, Ph, Bicarbonate, Glucose, Acid, Indicator

Semen Analysis Device

FDA classification

FDA Class 2 ·Semen Analysis Device

Strip, Dialysate Ph Indicator

FDA classification

FDA Class 2 ·Strip, Dialysate Ph Indicator

Material, Quality Control, Semen Analysis

FDA classification

FDA Class 2 ·Material, Quality Control, Semen Analysis

Ph Rate Measurement, Carbon-Dioxide

FDA classification

FDA Class 2 ·Ph Rate Measurement, Carbon-Dioxide

Ph Meter For Dialysis Hydrogen Ion Concentration

FDA classification

FDA Class 2 ·Ph Meter For Dialysis Hydrogen Ion Concentration

Analyzer, Ion, Hydrogen-Ion (Ph), Blood-Phase, Indwelling

FDA classification

FDA Class 2 ·Analyzer, Ion, Hydrogen-Ion (Ph), Blood-Phase, Indwelling

Electrode Measurement, Blood-Gases (Pco2, Po2) And Blood Ph

FDA classification

FDA Class 2 ·Electrode Measurement, Blood-Gases (Pco2, Po2) And Blood Ph

Bcr/Abl1 Monitoring Test

FDA classification

FDA Class 2 ·Bcr/Abl1 Monitoring Test