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

Intraocular Lens

FDA Pre-Market Approval
FDA Class 3 ·SOFTEC HDO

Cancer-Related Germline Gene Mutation Detection System

FDA Pre-Market Approval
FDA Class 3 ·myChoice HRD CDx

Cancer-Related Germline Gene Mutation Detection System

FDA Pre-Market Approval
FDA Class 3 ·myChoice HRD CDx

Implantable Cardioverter Defibrillator (Non-Crt)

FDA Pre-Market Approval
FDA Class 3 ·MODEL 0010 BIPOLAR ENDOCARDIAL LEAD

Agent, Absorbable Hemostatic, Collagen Based

FDA Pre-Market Approval
FDA Class 3 ·FLOSEAL HEMOSTATIC MATRIX

Automated External Defibrillators (Non-Wearable)

FDA Pre-Market Approval
FDA Class 3 ·Infant/Child Reduced Energy Defibrillation Electrodes

Intraocular Lens

FDA Pre-Market Approval
FDA Class 3 ·Softec HD/ HD PS, Softec I, Softec HDO, Softec HDM IOLs

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

FDA Pre-Market Approval
FDA Class 3 ·FoundationFocus CDx BRCA HRD

Stimulator, Spinal-Cord, Totally Implanted For Pain Relief

FDA Pre-Market Approval
FDA Class 3 ·Stimulator, Spinal-Cord, Totally Implanted For Pain Relief; Class III; Prospera SCS System

Stimulator, Spinal-Cord, Totally Implanted For Pain Relief

FDA Pre-Market Approval
FDA Class 3 ·Prospera SCS System, Resilience Surgical Lead

Stimulator, Spinal-Cord, Totally Implanted For Pain Relief

FDA Pre-Market Approval
FDA Class 3 ·Prospera SCS System, Resilience Surgical Lead, Embrace One

Stimulator, Spinal-Cord, Totally Implanted For Pain Relief

FDA Pre-Market Approval
FDA Class 3 ·Prospera SCS System Next Generation Active Anchor, TrueLock

Stimulator, Spinal-Cord, Totally Implanted For Pain Relief

FDA Pre-Market Approval
FDA Class 3 ·Prospera SCS System, Resilience Percutaneous Lead, Embrace One, TrueLock

Stimulator, Spinal-Cord, Totally Implanted For Pain Relief

FDA Pre-Market Approval
FDA Class 3 ·Prospera SCS System

Stimulator, Spinal-Cord, Totally Implanted For Pain Relief

FDA Pre-Market Approval
FDA Class 3 ·Prospera SCS System, Resilience Percutaneous Lead, Embrace One, TrueLock

Stimulator, Spinal-Cord, Totally Implanted For Pain Relief

FDA Pre-Market Approval
FDA Class 3 ·Prospera Spinal Cord Stimulation (SCS) System, Resilience Percutaneous Lead, HomeStream Remote Management

Stimulator, Spinal-Cord, Totally Implanted For Pain Relief

FDA Pre-Market Approval
FDA Class 3 ·Prospera Spinal Cord Stimulation (SCS) System, Resilience Percutaneous Lead, HomeStream Remote Management

Stimulator, Spinal-Cord, Totally Implanted For Pain Relief

FDA Pre-Market Approval
FDA Class 3 ·Prospera SCS System, Resilience Percutaneous Lead, Embrace One, TrueLock

Stimulator, Spinal-Cord, Totally Implanted For Pain Relief

FDA Pre-Market Approval
FDA Class 3 ·Prospera SCS System

Intraocular Lens

FDA Pre-Market Approval
FDA Class 3 ·SOFTEC HD,SOFTEC I,SOFTEC HD PS AND SOFTEC HDO