Heart-Valve, Non-Allograft Tissue

FDA Pre-Market Approval

FDA Class 3 ·Edwards Pericardial Aortic Bioprosthesis and INSPIRIS RESILIA Aortic Valve

System, Photopheresis, Extracorporeal

FDA Pre-Market Approval

FDA Class 3 ·THERAKOS CELLEX INSTRUMENT, THERAKOS CELLEX PHOTOPHRESSIS PROCEDURAL KIT (125 ML), CLX, THERAKOS CELLEX LIGHT ASSEMBLY ,

Stimulator, Bone Growth, Non-Invasive

FDA Pre-Market Approval

FDA Class 3 ·EBI BONE HEALING SYSTEM

System, Appendage Closure, Left Atrial

FDA Pre-Market Approval

FDA Class 3 ·WATCHMAN FLX Left Atrial Appendage Closure Device with Delivery System and WATCHMAN Left Atrial Appendage Closure Device

System, Appendage Closure, Left Atrial

FDA Pre-Market Approval

FDA Class 3 ·WATCHMAN FLX™ Left Atrial Appendage Closure Device with Delivery System, WATCHMAN Left Atrial Appendage (LAA) Closure Te

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

SPINAL SPHERES

FDA 510(k)

FDA Class 3 ·Unknown

INIVOX ELECTRODE/CATHETER SYS

FDA 510(k)

FDA Class 3 ·Unknown

PEEK SPINAL SPHERES

FDA 510(k)

FDA Class 3 ·Unknown