Implantable Cardioverter Defibrillator (Non-Crt)

FDA Pre-Market Approval

FDA Class 3 ·VARIOUS FAMILIES OF ICDS

Defibrillator, Automatic Implantable Cardioverter, With Cardiac Resynchronization (Crt-D)

FDA Pre-Market Approval

FDA Class 3 ·INSYNC CRT-D/CONCERTO & VARIOUS INSYNC FAMILY OF ICDS

Processor, Cervical Cytology Slide, Automated

FDA Pre-Market Approval

FDA Class 3 ·THIN PREP PROCESSORS

Analyzer, Data, Obstetric

FDA Pre-Market Approval

FDA Class 3 ·STAN S31 FETAL HEART MONITOR

Stimulator, Bone Growth, Non-Invasive

FDA Pre-Market Approval

FDA Class 3 ·Cervical-Stim

Stimulator, Bone Growth, Non-Invasive

FDA Pre-Market Approval

FDA Class 3 ·Spinal-Stim

Stimulator, Bone Growth, Non-Invasive

FDA Pre-Market Approval

FDA Class 3 ·PHYSIO-STIM BONE GROWTH STIMULATOR

Stimulator, Bone Growth, Non-Invasive

FDA Pre-Market Approval

FDA Class 3 ·SPINALOGIC, OL1000, AND OL1000 SINGLE COIL BONE GROWTH STIMULATORS

PADPRO SYSTEM DEFIBRILLATOR ELECTRODE ADAPTERS

FDA 510(k)

FDA Class 3 ·Cardiovascular

PADPRO, MODEL 2603

FDA 510(k)

FDA Class 3 ·Cardiovascular

PADPRO, MODEL 2502

FDA 510(k)

FDA Class 3 ·Cardiovascular

DDU-120 FULLY AUTOMATIC EXTERNAL DEFIBRILLATOR AND ACCESSORIES

FDA 510(k)

FDA Class 3 ·Cardiovascular

PADPRO MODEL #2516

FDA 510(k)

FDA Class 3 ·Cardiovascular

DEFIBTECH AED WITH ATTENUATED DEFIBRILLATION/MONITORING PADS, MODELS DDU-100 WITH DDP-200P

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

DDU-2300 SEMIAUTOMATIC EXTERNAL DEFIBRILLATOR AND ACCESSORIES

FDA 510(k)

FDA Class 3 ·Cardiovascular

DEFIBTECH ELECTRODE ADAPTER, MODEL DAC-300 SERIES

FDA 510(k)

FDA Class 3 ·Cardiovascular

SEMIAUTOMATIC EXTERNAL DEFIBRILLATOR AND ACCESSORIES

FDA 510(k)

FDA Class 3 ·Cardiovascular

DDU-2400/2450 SEMIAUTOMATIC EXTERNAL DEFIBRILLATOR AND ACCESSORIES

FDA 510(k)

FDA Class 3 ·Cardiovascular

PADPRO MODEL 2001, 2001-S, 2001-C, 2001-EPS

FDA 510(k)

FDA Class 3 ·Cardiovascular