10,000 results · 43ms · Sources: EU EUDAMED, US FDA

Somatic Gene Mutation Detection System

FDA Pre-Market Approval
FDA Class 3 ·Cobas 4800 BRAF V600 Mutation Test

Somatic Gene Mutation Detection System

FDA Pre-Market Approval
FDA Class 3 ·cobas 4800 BRAF V600 Mutation Test

Kit, Dna Detection, Human Papillomavirus

FDA Pre-Market Approval
FDA Class 3 ·Cobas 4800 Wash and Lysis Reagents

Stent, Coronary

FDA Pre-Market Approval
FDA Class 3 ·COBRA PzF NanoCoated Coronary Stent System

Stent, Coronary

FDA Pre-Market Approval
FDA Class 3 ·COBRA PzF NanoCoated Coronary Stent System

Somatic Gene Mutation Detection System

FDA Pre-Market Approval
FDA Class 3 ·COBAS 4800 BRAF V600 MUTATION TEST

Somatic Gene Mutation Detection System

FDA Pre-Market Approval
FDA Class 3 ·COBAS 4800 BRAF V600 MUTATION TEST

Stimulator, Spinal-Cord, Totally Implanted For Pain Relief

FDA Pre-Market Approval
FDA Class 3 ·Precision Spinal Cord Stimulator (SCS) Systems

Stimulator, Spinal-Cord, Totally Implanted For Pain Relief

FDA Pre-Market Approval
FDA Class 3 ·Saluda Medical Evoke SCS System

Stimulator, Spinal-Cord, Totally Implanted For Pain Relief

FDA Pre-Market Approval
FDA Class 3 ·Precision Spectra and Spectra Wave Writer Spinal Cord Stimulator (SCS) Systems

Stimulator, Electrical, Implanted, For Parkinsonian Symptoms

FDA Pre-Market Approval
FDA Class 3 ·Vercise Deep Brain Stimulation (DBS) Systems

Stimulator, Spinal-Cord, Totally Implanted For Pain Relief

FDA Pre-Market Approval
FDA Class 3 ·Senza Spinal Cord Stimulation (SCS) System

Stimulator, Spinal-Cord, Totally Implanted For Pain Relief

FDA Pre-Market Approval
FDA Class 3 ·Implantable Pulse Generator (IPG), Precision Spectra, Spectra WaveWriter, Precision Novi, Precision Montage, and Precisi

Hepatitis Viral B Dna Detection

FDA Pre-Market Approval
FDA Class 3 ·Cobas TaqMan HBV Test for Use with the High Pure System and Cobas AmpliPrep, CobasTaqMan HBV Test, v2.0

Stimulator, Spinal-Cord, Totally Implanted For Pain Relief

FDA Pre-Market Approval
FDA Class 3 ·Precision Spinal Cord Stimulator (SCS Systems)

Stimulator, Spinal-Cord, Totally Implanted For Pain Relief

FDA Pre-Market Approval
FDA Class 3 ·ITREL SPINAL CORD STIMULATION SYSTEM

Stimulator, Spinal-Cord, Totally Implanted For Pain Relief

FDA Pre-Market Approval
FDA Class 3 ·Senza Spinal Cord Stimulation (SCS) System

Stimulator, Electrical, Implanted, For Parkinsonian Symptoms

FDA Pre-Market Approval
FDA Class 3 ·Vercise Deep Brain Stimulation (DBS) Systems

Stimulator, Spinal-Cord, Totally Implanted For Pain Relief

FDA Pre-Market Approval
FDA Class 3 ·Pain Rechargeable (RC) Spinal Cord Stimulation (SCS) System: Inceptiv LT Implantable Neurostimulator (Model 977117); Int

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

FDA Pre-Market Approval
FDA Class 3 ·PRECICONTROL ANTI-HBC IGM (COBAS E 601)