14 results · 18ms · Sources: EU EUDAMED, US FDA

Next Generation Sequencing Oncology Panel, Somatic Or Germline Variant Detection System

FDA Pre-Market Approval
FDA Class 3 ·Guardant360 CDx

Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Metal/Polymer, Mobile Bearing

FDA Pre-Market Approval
FDA Class 3 ·LCS(R) Total Knee System

Implantable Pulse Generator, Pacemaker (Non-Crt)

FDA Pre-Market Approval
FDA Class 3 ·DUAL CHAMBER, IMPLANTABLE PULSE GENERATOR

Implantable Pacemaker Pulse-Generator

FDA Pre-Market Approval
FDA Class 3 ·PK-175/2,3m Patient Cable, PK-83, 2.5m

Implantable Pacemaker Pulse-Generator

FDA Pre-Market Approval
FDA Class 3 ·PK-222 and PK-Electrode Clip (accessory to Renamic)

Tissue Adhesive For Internal Use

FDA Pre-Market Approval
FDA Class 3 ·COHERA MEDICAL TISSUGLU SURGICAL ADHESIVE

Tissue Adhesive For Internal Use

FDA Pre-Market Approval
FDA Class 3 ·COHERA MEDICAL TISSUGLU SURGICAL ADHESIVE

Tissue Adhesive For Internal Use

FDA Pre-Market Approval
FDA Class 3 ·COHERA MEDICAL TISSUGLU

Tissue Adhesive For Internal Use

FDA Pre-Market Approval
FDA Class 3 ·COHERA MEDICAL TISSUGLU SURGICAL ADHESIVE

Tissue Adhesive For Internal Use

FDA Pre-Market Approval
FDA Class 3 ·COHERA MEDICAL TISSUEGLU SURGICAL ADHESIVE

Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Ceramic/Metal, Cemented Or Uncemented

FDA Pre-Market Approval
FDA Class 3 ·Ceramax® Ceramic Total Hip System

Sealant, Polymerizing

FDA Pre-Market Approval
FDA Class 3 ·Preveleak Surgical Sealant 4mL; Preveleak Delivery Tips 10 PK

Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Ceramic/Metal, Cemented Or Uncemented

FDA Pre-Market Approval
FDA Class 3 ·CERAMAX® Ceramic Total Hip System

HOME BLOOD PRESSURE KIT, ANEROID

FDA 510(k)
FDA Class 3 ·Cardiovascular