Implantable Cardioverter Defibrillator (Non-Crt)

FDA Pre-Market Approval

FDA Class 3 ·ACCESSORY (UPSIZING SLEEVE)/ACCESSORY (UPSIZING SLEEVE) FOR UNIPOLAR/ GEM/PCD TACHY CONTROL SYSTEM/JEWEL/LEAD END PIN

Implantable Cardioverter Defibrillator (Non-Crt)

FDA Pre-Market Approval

FDA Class 3 ·ACCESSORY (UPSIZING SLEEVE)/ACCESSORY (UPSIZING SLEEVE) FOR UNIPOLAR/ GEM/PCD TACHY CONTROL SYSTEM/JEWEL/LEAD END PIN

Automated External Defibrillators (Non-Wearable)

FDA Pre-Market Approval

FDA Class 3 ·Avive AED, Avive AED Pad Cartridge, Avive AED Training Cartridge, Avive USB Charging Cable, Avive USB Power Adapter

Implantable Cardioverter Defibrillator (Non-Crt)

FDA Pre-Market Approval

FDA Class 3 ·ACCESSORY (UPSIZING SLEEVE)/ACCESSORY (UPSIZING SLEEVE) FOR UNIPOLAR/GEM/PCD TACHY CONTROL SYSTEM/JEWEL/LEAD END PIN CAP

Percutaneously Delivered Prostheses And Tricuspid Valves

FDA Pre-Market Approval

FDA Class 3 ·Edwards EVOQUE Tricuspid Valve Replacement System

Pump, Infusion, Insulin, To Be Used With Invasive Glucose Sensor

FDA Pre-Market Approval

FDA Class 3 ·Animas Vibe System

Implantable Cardioverter Defibrillator (Non-Crt)

FDA Pre-Market Approval

FDA Class 3 ·ACCESSORY (UPSIZING SLEEVE)/UNIPOLAR/GEM/PCD TACHY CONTROL SYSTEM/JEWEL/LEAD END PIN CAP/MICRO JEWEL/II/TRANSVENE DEFIBR

Automated External Defibrillators (Non-Wearable)

FDA Pre-Market Approval

FDA Class 3 ·CPR-D-padz One-Piece Electrode Pad with Real CPR Help, OneStep CPR Complete Electrode, Pro-padz Biphasic Electrode, Pro-

Prosthesis, Knee, Patello/Femorotibial, Unconstrained, Uncemented, Porous, Coated, Polymer/Metal/Polymer

FDA Pre-Market Approval

FDA Class 3 ·NATURAL-KNEE(R) AND NATURAL KNEE(R)II W/CSTI(TM)

Implantable Pulse Generator, Pacemaker (Non-Crt)

FDA Pre-Market Approval

FDA Class 3 ·CONTAK RENEW 3 RF

Implantable Cardioverter Defibrillator (Non-Crt)

FDA Pre-Market Approval

FDA Class 3 ·VARIOUS FAMILIES OF ICD'S, GEM FAMILY, MICRO JEWEL II, MICRO JEWEL, JEWEL AND JEWEL PLUS FAMILY, PCD FAMILY,JEWEL CD 720

Automated External Defibrillators (Non-Wearable)

FDA Pre-Market Approval

FDA Class 3 ·Powerheart® G5 AED, Powerheart® AED G3 Plus, and Powerheart® AED G3

Automated Insulin Dosing , Threshold Suspend

FDA Pre-Market Approval

FDA Class 3 ·ENLITE SENSOR

Sensor, Glucose, Invasive

FDA Pre-Market Approval

FDA Class 3 ·PARADIGM REAL-TIME INSULIN PUMP

Stimulator, Bone Growth, Non-Invasive

FDA Pre-Market Approval

FDA Class 3 ·OL1000 DUAL COIL MEDIUM BONE GROWTH STIMULATION DEVICE

Intracranial Aneurysm Flow Diverter

FDA Pre-Market Approval

FDA Class 3 ·Surpass Elite Flow Diverter System

Automated External Defibrillators (Non-Wearable)

FDA Pre-Market Approval

FDA Class 3 ·Powerheart® AED G3 Pro

Ablation System, High Intensity Focused Ultrasound (Hifu), Mr-Guided

FDA Pre-Market Approval

FDA Class 3 ·Exablate 2100/2100 VI System

Acid, Hyaluronic, Intraarticular

FDA Pre-Market Approval

FDA Class 3 ·HYALGAN

Acid, Hyaluronic, Intraarticular

FDA Pre-Market Approval

FDA Class 3 ·HYALGAN