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

Ventricular (Assist) Bypass

FDA Pre-Market Approval
FDA Class 3 ·HeartMate 3™ Left Ventricular Assist System (LVAS)

Implantable Pulse Generator, Pacemaker (Non-Crt)

FDA Pre-Market Approval
FDA Class 3 ·INCEPTA, ENERGEN AND PUNTUA IDCS

FDA Pre-Market Approval
TOUCH® CMC 1 Prosthesis

Implantable Pulse Generator, Pacemaker (Non-Crt)

FDA Pre-Market Approval
FDA Class 3 ·INCEPTA, ENERGEN AND PUNTUA IDCS

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

FDA Pre-Market Approval
FDA Class 3 ·AB-CORE K HEPATITIS B CORE ANTIGEN 125I

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

FDA Pre-Market Approval
FDA Class 3 ·AB-CORE K HEPATITIS B CORE ANTIGEN 125I

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

FDA Pre-Market Approval
FDA Class 3 ·AB-CORE K HEPATITIS B CORE ANTIGEN 125I

System, Test, Automated, Antimicrobial Susceptibility, Short Incubation

FDA Pre-Market Approval
FDA Class 2 ·MICROSCAN(R)ALANINE-AMC R GRAM NEG.MIC PANELS

System, Test, Automated, Antimicrobial Susceptibility, Short Incubation

FDA Pre-Market Approval
FDA Class 2 ·MICROSCAN(R)ALANINE-AMC R GRAM NEG.MIC PANELS

Dressing, Wound And Burn, Interactive

FDA Pre-Market Approval
FDA Class 3 ·Integra Dermal Regeneration Template, Intergra Meshed Dermal Regeneration Template, and Integra Omnigraft Dermal Regener

Material, Dressing, Surgical, Polylactic Acid

FDA Pre-Market Approval
FDA Class 3 ·CollaCote, CollaTape, and CollaPlug Absorbable Collagen Wound Dressings for Dental Surgery

Agent, Absorbable Hemostatic, Collagen Based

FDA Pre-Market Approval
FDA Class 3 ·Helistat and Helitene Absorbable Collagen Hemostatic Agents

Agent, Absorbable Hemostatic, Collagen Based

FDA Pre-Market Approval
FDA Class 3 ·Collastat Absorbable Collagen Hemostatic Sponge and Collstat Absorbable Collagen Hemostatic - Microfibrillar Form

Agent, Absorbable Hemostatic, Collagen Based

FDA Pre-Market Approval
FDA Class 3 ·Helistat Absorbable Collagen Hemostatic Agent and Helitene Absorbable Collagen Hemostatic Agent- Fibrillar Form

Cardiac Ablation Percutaneous Catheter

FDA Pre-Market Approval
FDA Class 3 ·CHILLI II COOLED ABLATION SYSTEM

Bone Grafting Material, Dental, With Biologic Component

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

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

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

Material, Dressing, Surgical, Polylactic Acid

FDA Pre-Market Approval
FDA Class 3 ·CollaCote, CollaTape, CollaPlug Absorbable Collagen Wound Dressings for Dental Surgery

Agent, Absorbable Hemostatic, Collagen Based

FDA Pre-Market Approval
FDA Class 3 ·Collastat Absorbable Collagen Hemostatic Sponge and Collastat Absorbable Collagen Hemostatic Agent- Microfibrillar Form

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

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