2,480 results · 29ms · 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 ·Roche cobas® KRAS Mutation Test, Roche cobas® DNA Sample Preparation Kit

Material, Dressing, Surgical, Polylactic Acid

FDA Pre-Market Approval
FDA Class 3 ·COLLACOTE(TM) COLLATAPE(R) ABSORBABLE COLLEGAGEN WOUND DRESSINGS

Dressing, Wound And Burn, Interactive

FDA Pre-Market Approval
FDA Class 3 ·INTEGRA ARTIFICAL SKIN DERMAL REGENERATION TEMPLATE

Agent, Absorbable Hemostatic, Collagen Based

FDA Pre-Market Approval
FDA Class 3 ·HELISTAT HELITENE ABSORBABLE COLLAGEN HEMOSTATIC AGENT

Cardiac Ablation Percutaneous Catheter

FDA Pre-Market Approval
FDA Class 3 ·CHILLI COOLED ABLATION SYSTEM FOR THE CIRCUCOOL PUMP

Aspiration Therapy System

FDA Pre-Market Approval
FDA Class 3 ·AspireAssist

Aspiration Therapy System

FDA Pre-Market Approval
FDA Class 3 ·AspireAssist

Aspiration Therapy System

FDA Pre-Market Approval
FDA Class 3 ·AspireAssist

Aspiration Therapy System

FDA Pre-Market Approval
FDA Class 3 ·AspireAssist

Aspiration Therapy System

FDA Pre-Market Approval
FDA Class 3 ·AspireAssist

Aspiration Therapy System

FDA Pre-Market Approval
FDA Class 3 ·Pathway Clinical Trial Cohort

Aspiration Therapy System

FDA Pre-Market Approval
FDA Class 3 ·AspireAssist

Aspiration Therapy System

FDA Pre-Market Approval
FDA Class 3 ·AspireAssist

Aspiration Therapy System

FDA Pre-Market Approval
FDA Class 3 ·Aspire Assist

Aspiration Therapy System

FDA Pre-Market Approval
FDA Class 3 ·AspireAssist

Aspiration Therapy System

FDA Pre-Market Approval
FDA Class 3 ·AspireAssist

Aspiration Therapy System

FDA Pre-Market Approval
FDA Class 3 ·AspireAssist

Implanted Diaphragmatic/Phrenic Nerve Stimulator

FDA Pre-Market Approval
FDA Class 3 ·DIAPHRAGMATIC PACEMAKER PHRENIC NERVE

Wearable Automated External Defibrillator

FDA Pre-Market Approval
FDA Class 3 ·LIFEVEST WEARABLE DEFIBRILLATOR