(VCOM, IRVS, RVS) CENTRAL MONITORING STATION, V-LINK OR AMBULATORY TRANSMITTERS AND ARRHYTMIA DETECTOR AND ALARMS WITH

FDA 510(k)

FDA Class 2 ·Cardiovascular

STELA UT46 AND BT45/46 STRAIGHT TINED PACING LEADS, STELA UJ45 AND BJ44/45 J-SHAPED TINED PACING LEADS

FDA 510(k)

FDA Class 3 ·Cardiovascular

EX 45-BP, MODEL 330 132; EX 53-BP, MODEL 130 018; EX 60-BP, MODEL 330 133

FDA 510(k)

FDA Class 3 ·Cardiovascular

ZOLL M SERIES WITH RECTILINEAR BI-PHASIC OPTION (M SERIES BI-PHASIC)

FDA 510(k)

FDA Class 3 ·Cardiovascular

ALTERNATE STERLIZATION PROCESS & MODIFIED DF-1 LEAD CONNECTOR (MODIFICATION)

FDA 510(k)

FDA Class 3 ·Cardiovascular

DISETRONIC MULTIFUSE PUMP SYSTEM

FDA 510(k)

FDA Class 2 ·General Hospital

MODEL 1200 ABMULATORY INFUSION PUMP

FDA 510(k)

FDA Class 2 ·General Hospital

PURITAN-BENNETT 840 VENTILATIOR SYSTEM WITH VOLUME VENTILATION PLUS OPTION

FDA 510(k)

FDA Class 2 ·Anesthesiology

VENTILATOR, CONTINUOUS (RESPIRATOR), MODEL LTV 1000

FDA 510(k)

FDA Class 2 ·Anesthesiology

MICROTRAPPER/MICRODIGITRAPPER, ADD MODIFICATIONS

FDA 510(k)

FDA Class 2 ·Anesthesiology

REVEAL INSERTABLE LOOP RECORDER (ILR) SYSTEM

FDA 510(k)

FDA Class 2 ·Cardiovascular

DISETRONIC H-TRON PLUS V 100 INSULIN INFUSION PUMP

FDA 510(k)

FDA Class 2 ·General Hospital

MODEL 2188 CORONARY SINUS LEAD.

FDA 510(k)

FDA Class 3 ·Cardiovascular

VENTURI VENTILATOR

FDA 510(k)

FDA Class 2 ·Anesthesiology

PORTABLE INSTENSIVE CARE UNIT

FDA 510(k)

FDA Class 3 ·Cardiovascular

YP 45/15-BP; YP 53/15-BP; YP 60/15-BP

FDA 510(k)

FDA Class 3 ·Cardiovascular

NANOS, PIKOS 01/E01, 01-A, E01-B, LP 01/LP E01

FDA 510(k)

FDA Class 3 ·Cardiovascular

GORE-TEX FACIAL IMPLANT

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

MODEL 510 INFANT MONITOR

FDA 510(k)

FDA Class 2 ·Anesthesiology

INTERMEDICS MODEL 430-07 BIPOLAR IMPLANTABLE ENDOCARDIAL PACING LEAD

FDA 510(k)

FDA Class 3 ·Cardiovascular