10,000 results · 51ms · Sources: EU EUDAMED, US FDA

Barrier, Absorbable, Adhesion

FDA Pre-Market Approval
FDA Class 3 ·SEPRAFILM ADHESION BARRIER & SEPRAFILM PROCEDURE PACK

System, Hyperthermia, Rf/Microwave (Benign Prostatic Hyperplasia),Thermotherapy

FDA Pre-Market Approval
FDA Class 3 ·THERMATRX OFFICE THERMOTHERAPY SYSTEM

Stent, Iliac

FDA Pre-Market Approval
FDA Class 3 ·Wallstent Illiac Endoprosthesis with unistep plus delivery system

Wearable Automated External Defibrillator

FDA Pre-Market Approval
FDA Class 3 ·Wearable Cardioverter Defibrillator (WCD) 2000 Life Vest

Filler, Recombinant Human Bone Morphogenetic Protein, Collagen Scaffold, Osteoinduction

FDA Pre-Market Approval
FDA Class 3 ·Infuse Bone Graft

Intraocular Lens

FDA Pre-Market Approval
FDA Class 3 ·SINGLE PIECE POSTERIOR CHAMBER

Ventricular (Assist) Bypass

FDA Pre-Market Approval
FDA Class 3 ·THORATEC VENTRICULAR ASSIST DEVICE (VAD) SYSTEM

Aid, Surgical, Viscoelastic

FDA Pre-Market Approval
FDA Class 3 ·DISCOVISC, VISCOAT AND DUOVISC

Stent, Iliac

FDA Pre-Market Approval
FDA Class 3 ·EXPRESS LD ILLIAC PREMOUNTED STENT SYSTEM

Implantable Pulse Generator, Pacemaker (Non-Crt)

FDA Pre-Market Approval
FDA Class 3 ·INCEPTA,ENERGEN,PUNCTUA ICDS

Implantable Cardioverter Defibrillator (Non-Crt)

FDA Pre-Market Approval
FDA Class 3 ·SUBCUTANEOUS IMPLANTABLE DEFIBRILLATOR (S-ICD) SYSTEM

Device, Incontinence, Mechanical/Hydraulic

FDA Pre-Market Approval
FDA Class 3 ·AMS 800 ARTIFICIAL URINARY SPHINCTER

System, Imaging, Fluorescence

FDA Pre-Market Approval
FDA Class 3 ·KARL STORZ AUTOFLURESCENCE SYSTEM

Agent, Bulking, Injectable For Gastro-Urology Use

FDA Pre-Market Approval
FDA Class 3 ·COAPTITE 1.0CC

Pump, Infusion, Implanted, Programmable

FDA Pre-Market Approval
FDA Class 3 ·SynchroMed Infusion System, Ascenda Intrathecal Catheters

Stent, Coronary

FDA Pre-Market Approval
FDA Class 3 ·Rebel Platinum Chromium Coronary Stent System (Monrail and Over-The-Wire)

Lenses, Soft Contact, Extended Wear

FDA Pre-Market Approval
FDA Class 3 ·FREQUENCY XCEL TORIC XR

Permanent Defibrillator Electrodes

FDA Pre-Market Approval
FDA Class 3 ·SELECTSECURE LEAD

Implantable Cardioverter Defibrillator (Non-Crt)

FDA Pre-Market Approval
FDA Class 3 ·LATITUDE/PROGRAMMER/RECORDER/MONITOR

Agent, Bulking, Injectable For Gastro-Urology Use

FDA Pre-Market Approval
FDA Class 3 ·DEFLUX INJECTABLE GEL