10,000 results · 61ms · Sources: EU EUDAMED, US FDA

Drug Eluting Permanent Left Ventricular (Lv) Pacemaker Electrode

FDA Pre-Market Approval
FDA Class 3 ·Attain Ability Lead

Heart-Valve, Mechanical

FDA Pre-Market Approval
FDA Class 3 ·Masters Series™ Aortic Valved Graft with Hemashield Graft Technology (CAVGJ)

Intraocular Lens

FDA Pre-Market Approval
FDA Class 3 ·Clareon Intraocular Lenses with the AutonoMe™ Delivery System

Implant, Cochlear

FDA Pre-Market Approval
FDA Class 3 ·MED-EL COMBI 40+ COCHLEAR IMPLANT SYSTEM

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

FDA Pre-Market Approval
FDA Class 3 ·Consulta CRT-P C4TR01; Syncra CRT-P C2TR01

Test, Hepatitis B (B Core, Be Antigen, Be Antibody, B Core Igm)

FDA Pre-Market Approval
FDA Class 3 ·ARCHITECT HBSAG QUALITTATIVE/CONFIRMATORY

Stimulator, Spinal-Cord, Totally Implanted For Pain Relief

FDA Pre-Market Approval
FDA Class 3 ·POCKET ADAPTOR KIT, ITREL 3, SYNERGY & SYNERGY VERSITREL

Drug Eluting Permanent Left Ventricular (Lv) Pacemaker Electrode

FDA Pre-Market Approval
FDA Class 3 ·ATTAIN PERFORMA QUADRIPOLAR LEAD

Stimulator, Spinal-Cord, Totally Implanted For Pain Relief

FDA Pre-Market Approval
FDA Class 3 ·PRECISION SPINAL CORD STIMULATOR (SCS)SYSTEM

Cardiac Ablation Percutaneous Catheter

FDA Pre-Market Approval
FDA Class 3 ·NAVISTAR & CELSIUS FAMILIES OF CATHETERS

Pulse Generator, Permanent, Implantable

FDA Pre-Market Approval
FDA Class 3 ·AFFINITY/INTEGRITY/VICTORY/ZEPHYR FAMILY OF PACEMAKERS

Implant, Dermal, For Aesthetic Use

FDA Pre-Market Approval
FDA Class 3 ·Restylane Refyne and Restylane Defyne

P2psa

FDA Pre-Market Approval
FDA Class 3 ·ACCESS P2PSA CALIBRATOR ON THE ACCESS IMMUNOASSAY ANALYZER

Drug Eluting Permanent Right Ventricular (Rv) Or Right Atrial (Ra) Pacemaker Electrodes

FDA Pre-Market Approval
FDA Class 3 ·CapSure SP Novus/CapSure SP Z/CapSure Z Novus/Vitatron Impulse II Lead

Sensor, Glucose, Invasive

FDA Pre-Market Approval
FDA Class 3 ·DEXCOM SEVEN PLUS CONTINUOUS GLUCOSE MONITORING SYSTEM

Permanent Defibrillator Electrodes

FDA Pre-Market Approval
FDA Class 3 ·CAPSUREFIX NOVUS LEAD

Pulse Generator, Permanent, Implantable

FDA Pre-Market Approval
FDA Class 3 ·CAPSURE LEAD

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

FDA Pre-Market Approval
FDA Class 3 ·FRONTIER/FRONTIER II/ANTHEM/AESCULA PACEMAKERS/CRT-PS

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

FDA Pre-Market Approval
FDA Class 3 ·QUICKSITE & QUICKFLEX FAMILIES OF LEADS

Stent, Superficial Femoral Artery

FDA Pre-Market Approval
FDA Class 3 ·GORE VIABAHN ENDOPROSTHESIS