RETROX RX 45-JBP 124774, 53-JBP 124775, 53-BP 124776, 60-124777

FDA 510(k)

FDA Class 3 ·Cardiovascular

TECOTHANE 75D POLYURETHANE RESIN FOR PULSE GENERATOR CONNECTOR MODULES

FDA 510(k)

FDA Class 3 ·Cardiovascular

TRANSVENOUS, PERMANENT TINED TARGET TIP PACING LEADS/TRANSVENOUS, PERMANENT SCREW-IN PACING LEADS

FDA 510(k)

FDA Class 3 ·Cardiovascular

MODEL 5071 MYOCARDIAL PACING LEAD

FDA 510(k)

FDA Class 3 ·Cardiovascular

PACING LEAD MODEL 1188T

FDA 510(k)

FDA Class 3 ·Cardiovascular

CCS MAESTRO(R) II SERIES 200 MODELS 235 AND 227 CARDIAC PACEMAKER

FDA 510(k)

FDA Class 3 ·Cardiovascular

SILICONE BIPOLAR LEAD MODELS 1136T, 1142T &1146T

FDA 510(k)

FDA Class 3 ·Cardiovascular

MODELS 5866-45 AND 5866-46 SIZING SLEEVE

FDA 510(k)

FDA Class 3 ·Cardiovascular

PX 53/15-BP, MODEL 130 050 AND PX 60/15-BP, MODEL 130 051

FDA 510(k)

FDA Class 3 ·Cardiovascular

SENTRY SEMIAUTOMATIC EXTERNAL DEFIBRILLATOR; EXTERNAL DEFIBRILLATION PADS (ELECTRODES) DDP-100; BATTERY PACK 1200MAH; BA

FDA 510(k)

FDA Class 3 ·Cardiovascular

POWERHEART AECD

FDA 510(k)

FDA Class 3 ·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

MODEL 2188 CORONARY SINUS LEAD.

FDA 510(k)

FDA Class 3 ·Cardiovascular

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

INTERMEDICS MODEL 430-07 BIPOLAR IMPLANTABLE ENDOCARDIAL PACING LEAD

FDA 510(k)

FDA Class 3 ·Cardiovascular