504 results · 21ms · Sources: EU EUDAMED, US FDA

Implantable Pulse Generator, Pacemaker (Non-Crt)

FDA Pre-Market Approval
FDA Class 3 ·VITALITY HE, RENEWAL 3 AND RENEWAL 3RF FAMILIES OF ICDS

System, Colorectal Neoplasia, Dna Methylation And Hemoglobin Detection

FDA Pre-Market Approval
FDA Class 3 ·Epi proColon

System, Colorectal Neoplasia, Dna Methylation And Hemoglobin Detection

FDA Pre-Market Approval
FDA Class 3 ·Epi proColon

Stimulator, Invasive Bone Growth

FDA Pre-Market Approval
FDA Class 3 ·SPF SPINAL FUSION STIMULATOR

Implant, Corneal, Refractive

FDA Pre-Market Approval
FDA Class 3 ·INTACS PRESCRIPTION INSERTS

System, Colorectal Neoplasia, Dna Methylation And Hemoglobin Detection

FDA Pre-Market Approval
FDA Class 3 ·COLOGUARD

System, Colorectal Neoplasia, Dna Methylation And Hemoglobin Detection

FDA Pre-Market Approval
FDA Class 3 ·Cologuard

Pump, Infusion, Implanted, Programmable

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

System, Colorectal Neoplasia, Rna Markers And Hemoglobin Detection

FDA Pre-Market Approval
FDA Class 3 ·ColoSense®

Somatic Gene Mutation Detection System

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

System, Colorectal Neoplasia, Rna Markers And Hemoglobin Detection

FDA Pre-Market Approval
FDA Class 3 ·ColoSense

Permanent Defibrillator Electrodes

FDA Pre-Market Approval
FDA Class 3 ·Tunneling Tool

System, Colorectal Neoplasia, Dna Methylation And Hemoglobin Detection

FDA Pre-Market Approval
FDA Class 3 ·Multi-Target Stool DNA (mtsDNA) Test, Cologuard Plus™

Somatic Gene Mutation Detection System

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

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

FDA Pre-Market Approval
FDA Class 3 ·FoundationOne Liquid CDx (F1 Liquid CDx)

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

FDA Pre-Market Approval
FDA Class 3 ·ONCO/Reveal Dx Lung & Colon Cancer Assay (O/RDx-LCCA)

Somatic Gene Mutation Detection System

FDA Pre-Market Approval
FDA Class 3 ·COBAS KRAS MUTATION TEST

Implantable Pulse Generator, Pacemaker (Non-Crt)

FDA Pre-Market Approval
FDA Class 3 ·CONTAK RENEW 3 RF

Somatic Gene Mutation Detection System

FDA Pre-Market Approval
FDA Class 3 ·COBAS KRAS MUTATION TEST

Ablation System, High Intensity Focused Ultrasound (Hifu), Mr-Guided

FDA Pre-Market Approval
FDA Class 3 ·EXABLATE