987 results
·
19ms
·
Sources: EU EUDAMED, US FDA
Filters
Classification: FDA Class 3
×
Implantable Cardioverter Defibrillator (Non-Crt)
FDA Pre-Market Approval
FDA Class 3
·ENTRUST,SECURA,GEM II/III VR/DR,INTRINSIC/INTRINSIC 30,MAXIMO VR/DR,MAXIMO II,MARQUIS VR/DR,PROTECTA/PROTECTA XT
Device, Thermal Ablation, Endometrial
FDA Pre-Market Approval
FDA Class 3
·Mater Water Vapor System - Model # GEA-SYS-16-0500, Mara Water Vapor Probe Kit - Model # DDK-16-050, Mara Console - Mode
Implantable Cardioverter Defibrillator (Non-Crt)
FDA Pre-Market Approval
FDA Class 3
·VARIOUS FAMILIES OF ICD'S, GEM FAMILY, MICRO JEWEL II, MICRO JEWEL, JEWEL AND JEWEL PLUS FAMILY, PCD FAMILY,JEWEL CD 720
Ablation System, High Intensity Focused Ultrasound (Hifu), Mr-Guided
FDA Pre-Market Approval
FDA Class 3
·Exablate 2100/2100 VI System
Prosthesis, Breast, Noninflatable, Internal, Silicone Gel-Filled
FDA classification
FDA Class 3
·Prosthesis, Breast, Noninflatable, Internal, Silicone Gel-Filled
Acid, Hyaluronic, Intraarticular
FDA Pre-Market Approval
FDA Class 3
·GELSYN-3
Test, Prostate Specific Antigen, Free, (Noncomplexed) To Distinguish Prostate Cancer From Benign Conditions
FDA Pre-Market Approval
FDA Class 3
·IMMULITE / IMMULITE 1000 AND IMMULITE 2000 FREE PSA ASSAYS