419 results · 26ms · Sources: EU EUDAMED, US FDA

Implantable Cardioverter Defibrillator (Non-Crt)

FDA Pre-Market Approval
FDA Class 3 ·ENDOTAK RELIANCE G/SG LEADS

Implantable Cardioverter Defibrillator (Non-Crt)

FDA Pre-Market Approval
FDA Class 3 ·ENDOTAK RELIANCE S /GS /G

Implantable Cardioverter Defibrillator (Non-Crt)

FDA Pre-Market Approval
FDA Class 3 ·ENDOTAK RELIANCE G/SG DEFIBRILLATION LEADS AND G/SG WITH 4-SITE CONNECTOR DEFIBRILLATION LEADS

Implantable Cardioverter Defibrillator (Non-Crt)

FDA Pre-Market Approval
FDA Class 3 ·ENDOTAK RELIANCE G/SG WITH 4-SITE CONNECTOR DEFIBRILLATION LEADS, ENDOTAK RELIANCE G/SG DEFIBRILLATION LEADS

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

FDA Pre-Market Approval
FDA Class 3 ·IMMULITE 2000 XPI ANTI-HBC IMG

Implant, Dermal, For Aesthetic Use

FDA Pre-Market Approval
FDA Class 3 ·Belotero Balance (+) Lidocaine

Implantable Cardioverter Defibrillator (Non-Crt)

FDA Pre-Market Approval
FDA Class 3 ·ENDOTAK RELIANCE G/SG LEAD MODELS 0180-0187

Implantable Cardioverter Defibrillator (Non-Crt)

FDA Pre-Market Approval
FDA Class 3 ·ENDO RELIANCE/ S/G/SG/DF4 DEFIBRILLATION LEADS

Filler, Recombinant Human Bone Morphogenetic Protein, Collagen Scaffold With Metal Prosthesis, Osteoinduction

FDA Pre-Market Approval
FDA Class 3 ·Infuse Bone Graft/Medtronic Interbody Fusion Device

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

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

Bone Grafting Material, Dental, With Biologic Component

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

Kit, Dna Detection, Human Papillomavirus

FDA Pre-Market Approval
FDA Class 3 ·cobas HPV Mg/Mn

Implantable Cardioverter Defibrillator (Non-Crt)

FDA Pre-Market Approval
FDA Class 3 ·ENDOTAK RELIANCE S, ENDOTAK RELIANCE G/SG, ENDOTAK RELIANCE 4-SITE LEAD FAMILY

Stent, Coronary

FDA Pre-Market Approval
FDA Class 3 ·MAGIC WALLSTENT EDNDOPROSTHESIS AND RADIUS CORONARY STENT WITH DELIVERY SYSTEM

Barrier, Absorbable, Adhesion

FDA Pre-Market Approval
FDA Class 3 ·INTERCEED (TC7) ABSORBABLE ADHESION BARRIER

Lenses, Soft Contact, Extended Wear

FDA Pre-Market Approval
FDA Class 3 ·BIOMEDICS 38 (POLYMACON) HYDROPHILIC CONTACT LENSES

System, Test, Her-2/Neu, Nucleic Acid Or Serum

FDA Pre-Market Approval
FDA Class 3 ·HER2 FISH PHARMDX KIT

Implantable Pacemaker Pulse-Generator

FDA Pre-Market Approval
FDA Class 3 ·MEDTRONIC KAPPA 700 SERIES PULSE GENERATOR PRODUCT FAMILY

Filler, Bone Void, Non-Osteoinduction

FDA Pre-Market Approval
FDA Class 3 ·COLLAGRAFT STRIP BONE GRAFT MATRIX

Permanent Pacemaker Electrode

FDA Pre-Market Approval
FDA Class 3 ·THINLINE/FINELINE