BIO-CYBERNETIC CARDIO-DIAGNOSIS SYSTEM (BKD)

FDA 510(k)

FDA Class 2 ·Cardiovascular

EVOL ha - D Lateral Interbody Fusion System

FDA 510(k)

FDA Class 2 ·Orthopedic

Consult Station TS

FDA 510(k)

FDA Class 2 ·Cardiovascular

Lithoplasty Peripheral Balloon Dilatation Catheter, Lithoplasty Generator and Connector Cable, Lithoplasty Connector Cable

FDA 510(k)

FDA Class 2 ·Cardiovascular

GLUCOLEADER ENHANCE SELF-MONITORING OF BLOOD GLUCOSE SYSTEM

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

GlucoLeader Enhance 2 Blood Glucose Monitoring System

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

EVOLUTION BLOOD GLUCOSE MONITORING SYSTEM

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

TEST, BLOOD GLUCOSE SYSTEM

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

GlucoLeader Enhance Blood Glucose Monitoring System

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

Goodlife AC-300 Blood Glucose Monitoring System, Goodlife AC-301 Blood Glucose Monitoring System, Goodlife AC-302 Blood Glucose Monitoring System, Goodlife AC 303 Blood Glucose Monitoring System, Goodlife AC-304 Blood Glucose Monitoring System Goodlife AC-305 Blood Glucose Monitoring System, Goodlife AC-300 Professional Blood Glucose Monitoring System, Goodlife AC-301 Professional Blood Glucose Monitoring System Goodlife AC-30

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

GL GOODLIFE SERIES BLOOD GLUCOSE MONITORING SYSMTEM

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

GOODLIFE CS-200 (SINGLE PATIENT USE), CS-200 PROFESSIONAL (MULTIPLE PATIENT USE) BLOOD GLUCOSE MONITORING SYSTEMS

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

PRECICHEK NS-101 POCT PROFESSIONAL BLOOD GLUCOSE MONITORING SYSTEM

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

FIA Blood Glucose Monitoring System (G2)

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

GLUCOLEADER VALUE

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

8800 SERIES MICRO-PROCESSOR-BASED APNEA MONITORS

FDA 510(k)

FDA Class 2 ·Anesthesiology

REVEAL PLUS INSERTABLE LOOP RECORDER SYSTEM, MODEL 9526 IMPLANTED RECORDER AND MODEL 6191 PATIENT ACTIVATOR

FDA 510(k)

FDA Class 2 ·Cardiovascular

REVEAL INSERTABLE LOOP RECORDER (ILR) SYSTEM

FDA 510(k)

FDA Class 2 ·Cardiovascular

Hi-D Imaging 4TAVR

FDA 510(k)

FDA Class 2 ·Radiology

BIO-MONITOR GENTAMICIN

FDA 510(k)

FDA Class 2 ·Clinical Toxicology