136 results · 37ms · Sources: EU EUDAMED, US FDA

Somatic Gene Mutation Detection System

FDA Pre-Market Approval
FDA Class 3 ·THERASCREEN EGFR RGQ PCR KIT

Somatic Gene Mutation Detection System

FDA Pre-Market Approval
FDA Class 3 ·THERASCREEN KRAS RGQ PCR KIT

System, Hemodynamic, Implantable

FDA Pre-Market Approval
FDA Class 3 ·CardioMEMS HF System

Implant, Dermal, For Aesthetic Use

FDA Pre-Market Approval
FDA Class 3 ·COSMODERM 1 HUMAN-BASED COLLAGEN, COSMODERM 2 HUMAN-BASED COLLAGEN AND COSMOPLAST HUMAN-BASED COLLAGEN

Implant, Dermal, For Aesthetic Use

FDA Pre-Market Approval
FDA Class 3 ·BELLAFILL

Heart-Valve, Non-Allograft Tissue

FDA Pre-Market Approval
FDA Class 3 ·Edwards Pericardial Aortic Bioprosthesis, Edwards Pericardial Mitral Bioprosthesis, INSPIRIS™ RESILIA™ Aortic Valve, KON

Heart-Valve, Non-Allograft Tissue

FDA Pre-Market Approval
FDA Class 3 ·Edwards Pericardial Aortic Bioprosthesis, Edwards Pericardial Mitral Bioprosthesis, INSPIRIS™ RESILIA™ Aortic Valve, KON

Heart-Valve, Non-Allograft Tissue

FDA Pre-Market Approval
FDA Class 3 ·Edwards Pericardial Aortic Bioprosthesis, Edwards Pericardial Mitral Bioprosthesis, INSPIRIS™ RESILIA™ Aortic Valve, KON

Barrier, Absorbable, Adhesion

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

Barrier, Absorbable, Adhesion

FDA Pre-Market Approval
FDA Class 3 ·GYNECARE INTERCEED Absorbable Adhesion Barrier

Barrier, Absorbable, Adhesion

FDA Pre-Market Approval
FDA Class 3 ·SEPRAFILM ADHESION BARRIER

Barrier, Absorbable, Adhesion

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

Barrier, Absorbable, Adhesion

FDA Pre-Market Approval
FDA Class 3 ·GYNECARE INTERCEED ABSORBABLE ADHESION BARRIER

Barrier, Absorbable, Adhesion

FDA Pre-Market Approval
FDA Class 3 ·Seprafilm Adhesion Barrier

Barrier, Absorbable, Adhesion

FDA Pre-Market Approval
FDA Class 3 ·GYNECARE INTERCEED ABSORBABLE ADHESION BARRIER

Barrier, Absorbable, Adhesion

FDA Pre-Market Approval
FDA Class 3 ·SEPRAFILM BIORESORBABLE MEMBRANE

Barrier, Absorbable, Adhesion

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

Barrier, Absorbable, Adhesion

FDA Pre-Market Approval
FDA Class 3 ·SEPRAFILM ADHESION BARRIER

Barrier, Absorbable, Adhesion

FDA Pre-Market Approval
FDA Class 3 ·GYNECARE INTERCEED™ Absorbable Adhesion Barrier

Barrier, Absorbable, Adhesion

FDA Pre-Market Approval
FDA Class 3 ·Seprafilm Adhesion Barrier