529 results · 20ms · Sources: EU EUDAMED, US FDA

Stimulator, Bone Growth, Non-Invasive

FDA Pre-Market Approval
FDA Class 3 ·EXOGEN ULTRASOUND BONE HEALING SYSTEM

Reader, Cervical Cytology Slide, Automated

FDA Pre-Market Approval
FDA Class 3 ·FOCALPOINT SYSTEMCREENING SYSTEM

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

FDA Pre-Market Approval
FDA Class 3 ·HEPANOSTIKA(TM) HBEAG/ANTI HBE MICROELISA(TM) SYST

Fluid, Hysteroscopy

FDA Pre-Market Approval
FDA Class 3 ·HYSKON (32% DEXTRAN 70)

Sealant, Dural

FDA Pre-Market Approval
FDA Class 3 ·Adherus AutoSpray Dural Sealant, Adherus AutoSpray ET Dural Sealant

Acid, Hyaluronic, Intraarticular

FDA Pre-Market Approval
FDA Class 3 ·DUROLANE

Device, Thermal Ablation, Endometrial

FDA Pre-Market Approval
FDA Class 3 ·HER OPTION CRYOABLATION THERAPY SYSTEM

Device, Thermal Ablation, Endometrial

FDA Pre-Market Approval
FDA Class 3 ·HER OPTION OFFICE CRYOABLATION THERAPY SYSTEM

Acid, Hyaluronic, Intraarticular

FDA Pre-Market Approval
FDA Class 3 ·DUROLANE

Fluid, Hysteroscopy

FDA Pre-Market Approval
FDA Class 3 ·HYSKON (32% DEXTRAN 70)

Device, Thermal Ablation, Endometrial

FDA Pre-Market Approval
FDA Class 3 ·AEGEA Vapor System, AEGEA Vapor Probe Procedure Kit, AEGEA Vapor Generator, AEGEA Vapor Generator Accessory Kit

Device, Thermal Ablation, Endometrial

FDA Pre-Market Approval
FDA Class 3 ·MARA Water Vapor System

Device, Thermal Ablation, Endometrial

FDA Pre-Market Approval
FDA Class 3 ·Mara Water Vapor Ablation System, Mara Water Vapor System, Mara Console

Reader, Cervical Cytology Slide, Automated

FDA Pre-Market Approval
FDA Class 3 ·BD FocalPoint GS Imaging System

Sealant, Dural

FDA Pre-Market Approval
FDA Class 3 ·ADHERUS AUTOSPRAY DURAL SEALANT

Fluid, Hysteroscopy

FDA Pre-Market Approval
FDA Class 3 ·HYSKON HYSTEROSCOPY FLUID

Device, Thermal Ablation, Endometrial

FDA Pre-Market Approval
FDA Class 3 ·HER OPTION CRYOABLATION THERAPY SYSTEM

Fluid, Hysteroscopy

FDA Pre-Market Approval
FDA Class 3 ·HYSKON (32% DEXTRAN 70)

Reader, Cervical Cytology Slide, Automated

FDA Pre-Market Approval
FDA Class 3 ·BD FOCAL POINT SLIDE PROFILER

Stimulator, Ultrasound And Muscle, For Use Other Than Applying Therapeutic Deep

FDA Pre-Market Approval
FDA Class 3 ·EXOGEN 4000+BONE HEALING SYSTEM