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

FDA Pre-Market Approval

FDA Class 3 ·Promote+; Unify; Unify Quadra; Unify Assura; Quadra Assura; Quadra Assura (MR Conditional); Quadra Assura MP; Quadra Ass

Sensor, Glucose, Invasive, Non-Adjunctive, Factory-Calibrated, User-Initiated

FDA Pre-Market Approval

FDA Class 3 ·FreeStyle Libre Flash Glucose Monitoring System

Agent, Bulking, Injectable For Gastro-Urology Use

FDA Pre-Market Approval

FDA Class 3 ·COAPTITE Injectable Implant

Stent, Superficial Femoral Artery

FDA Pre-Market Approval

FDA Class 3 ·GORE VIABAHN Endoprosthesis, GORE VIABAHN Endoprosthesis with Heparin Bioactive Surface

Acid, Hyaluronic, Intraarticular

FDA Pre-Market Approval

FDA Class 3 ·Synvisc, Synvisc-One

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

FDA Pre-Market Approval

FDA Class 3 ·EPIC HF/ATLAS+HF CRT-D FAMILY OF DEVICES

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

FDA Pre-Market Approval

FDA Class 3 ·Amplia MRI/Amplia MRI Quad;Brava/Brava Quad; Claria MRI/Claria MRI Quad; Compia MRI/Compia MRI Quad; Consulta; Maximo II

Pulse Generator, Pacemaker, Implantable, With Cardiac Resynchronization (Crt-P)

FDA Pre-Market Approval

FDA Class 3 ·ALLURE QUADRA, RF, MP

Permanent Defibrillator Electrodes

FDA Pre-Market Approval

FDA Class 3 ·ACUITY STEERABLE FAMILY OF LEADS

Pulse Generator, Permanent, Implantable

FDA Pre-Market Approval

FDA Class 3 ·VARIOUS FAMILIES OF PACEMAKERS

Stent, Iliac

FDA Pre-Market Approval

FDA Class 3 ·SMART NITINOL STENT SYSTEM/SMART CONTROL NITINOL STENT SYSTEMS

System, Endovascular Graft, Aortic Aneurysm Treatment

FDA Pre-Market Approval

FDA Class 3 ·ANEURX STENT GRAFT SYSTEM

Implantable Pulse Generator, Pacemaker (Non-Crt)

FDA Pre-Market Approval

FDA Class 3 ·PULSAR/DISCOVERY/MERIDIAN

Pulse Generator, Pacemaker, Implantable, With Cardiac Resynchronization (Crt-P)

FDA Pre-Market Approval

FDA Class 3 ·FRONTIER/FRONTIER II FAMILY OF CRT-PS

Bone Grafting Material, Dental, With Biologic Component

FDA Pre-Market Approval

FDA Class 3 ·PEPGEN P-15/PEPGEN P-15 FLOW

Bone Grafting Material, Dental, With Biologic Component

FDA Pre-Market Approval

FDA Class 3 ·INFUSE BONE GRAFT

Stimulator, Spinal-Cord, Totally Implanted For Pain Relief

FDA Pre-Market Approval

FDA Class 3 ·RESTOREPRIME IMPLANTABLE NEUROSTIMULATOR/PRIMEADVANCED/RESTORE/RESTOREULTRA/ITREL 3/SYNERGY/SYNERGY VERSITREL INS

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

FDA Pre-Market Approval

FDA Class 3 ·PARADYM CRT-D 8750, PARADYM RF CRT-D9750 (ZL101), PARADYM CRT-D9750 (ZL102)

Catheter, Coronary, Atherectomy

FDA Pre-Market Approval

FDA Class 3 ·ROTABLATOR ROTATIONAL ATHERECTOMY SYSTEM

Implantable Pulse Generator, Pacemaker (Non-Crt)

FDA Pre-Market Approval

FDA Class 3 ·Percepta Bipolar CRT-P; Percepta Quadripolar CRT-P; Serena Bipolar CRT-P; Serena Quadripolar CRT-P; Solara Bipolar CRT-P