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

Agent, Bulking, Injectable For Gastro-Urology Use

FDA Pre-Market Approval
FDA Class 3 ·BARD TEGRESS URETHRAL IMPLANT

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

FDA Pre-Market Approval
FDA Class 3 ·VITROS IMMUNODIAGNOSTIC PRODUCTS ANTI-HBS QUANTITATIVE REAGENT PACK AND CALIBRATOR

Bone Sonometer

FDA Pre-Market Approval
FDA Class 2 ·ACHILLES EXPRESS ULTRASONOMETER

Cardiac Ablation Percutaneous Catheter

FDA Pre-Market Approval
FDA Class 3 ·EPT-1000 CARDIAC ABLATION SYSTEM

Spinal Pedicle Screw, Fixation, Appliance System

FDA Pre-Market Approval
FDA Class 3 ·LUMBAR I/F CAGE WITH VSP SPINAL SYSTEM

Intracranial Coil-Assist Stent

FDA Pre-Market Approval
FDA Class 3 ·Neuroform Atlas® Stent System

Prosthesis, Intervertebral Disc

FDA Pre-Market Approval
FDA Class 3 ·M6-C Artificial Cervical Disc

Stent, Renal

FDA Pre-Market Approval
FDA Class 3 ·RX HERCULINK ELITE RENAL STENT SYSTEM

Implantable Cardioverter Defibrillator (Non-Crt)

FDA Pre-Market Approval
FDA Class 3 ·CARELINK MONITORS, MODELS 2490G AND 2490J

Catheter, Percutaneous, Cardiac Ablation, For Treatment Of Atrial Fibrillation

FDA Pre-Market Approval
FDA Class 3 ·ARCTIC FRONT CARDIAC CRYOABLATION SYSTEM

Prosthesis, Breast, Noninflatable, Internal, Silicone Gel-Filled

FDA Pre-Market Approval
FDA Class 3 ·SIENTRA SILICONE GEL BREAST IMPLANTS

Implant, Dermal, For Aesthetic Use

FDA Pre-Market Approval
FDA Class 3 ·HYLAFORM, HYLAFORM PLUS, ND CAPTIQUE

Device, Thermal Ablation, Endometrial

FDA Pre-Market Approval
FDA Class 3 ·GYNECARE THERMACHOICE 3 UTERINE BALLOON THERAPY SYSTEM

Occluder, Patent Ductus, Arteriosus

FDA Pre-Market Approval
FDA Class 3 ·NIT-OCCLUD PDA

Cardiac Ablation Percutaneous Catheter

FDA Pre-Market Approval
FDA Class 3 ·Biosense Webster Cables, Celsius Catheter, Celsius FLTR, Deflectable Diagnostic/Ablation Catheter,EZ Steer Catheter, EZ

Pump, Infusion, Implanted, Programmable

FDA Pre-Market Approval
FDA Class 3 ·SYNCHROMED & SYNCHROMED EL IMPLANTABLE PROGRAMMABLE INFUSION PUMPS

Coronary Drug-Eluting Stent

FDA Pre-Market Approval
FDA Class 3 ·XIENCE PRIME & XIENCE PRIME LL EVEROLIMUS ELUTING CORONARY STENT SYSTEM

Pump, Infusion, Implanted, Programmable

FDA Pre-Market Approval
FDA Class 3 ·3000 Series Implantable Infusion Pump and the MedStream Programmable Infusion System and Accessories

Implant, Dermal, For Aesthetic Use

FDA Pre-Market Approval
FDA Class 3 ·RADIESSE INJECTABLE IMPLANT

Defibrillator, Automatic Implantable Cardioverter, With Cardiac Resynchronization (Crt-D)

FDA Pre-Market Approval
FDA Class 3 ·MT PAS ACUITY X4