876 results · 19ms · Sources: EU EUDAMED, US FDA

Kit, Assay, Estrogen Receptor

FDA Pre-Market Approval
FDA Class 3 ·RIANEN 3H

Kit, Assay, Progesterone Receptor

FDA Pre-Market Approval
FDA Class 3 ·RIANEN(TM) (3H) PROGESTIN RECEPTOR ASSAY KIT

Kit, Assay, Progesterone Receptor

FDA Pre-Market Approval
FDA Class 3 ·RIANEN(TM) (3H) PROGESTIN RECEPTOR ASSAY KIT

Kit, Assay, Progesterone Receptor

FDA Pre-Market Approval
FDA Class 3 ·RIANEN(TM) (3H) PROGESTIN RECEPTOR ASSAY KIT

Kit, Assay, Estrogen Receptor

FDA Pre-Market Approval
FDA Class 3 ·RIANEN 3H

Implantable Pacemaker Pulse-Generator

FDA Pre-Market Approval
FDA Class 3 ·Reply SR, Reply Dr, Esprit SR, Esprit DR (2nd generation , i.e. V2 ) & (5TH generation i.e.V5)

System, Endovascular Graft, Aortic Aneurysm Treatment

FDA Pre-Market Approval
FDA Class 3 ·GORE®1 EXCLUDER® AAA Endoprosthesis (AAA), GORE® EXCLUDER® Iliac Branch Endoprosthesis (IBE)

Aid, Surgical, Viscoelastic

FDA Pre-Market Approval
FDA Class 3 ·AMVISC & AMVISC PLUS

Implant, Dermal, For Aesthetic Use

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

Implant, Dermal, For Aesthetic Use

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

Stimulator, Hypoglossal Nerve, Implanted, Apnea

FDA Pre-Market Approval
FDA Class 3 ·INSPIRE UPPER AIRWAY STIMULATION THERAPY SYSTEM

Lymph Node Location System During Sentinel Biopsy Procedure

FDA Pre-Market Approval
FDA Class 3 ·MagtraceTM and Sentimag(R) Magnetic Locatization System

Implant, Dermal, For Aesthetic Use

FDA Pre-Market Approval
FDA Class 3 ·RESTYLANE/PERLANE/RESTYLANE-L/PERLANE-L INJECTABLE GELS

System, Hyperthermia, Rf/Microwave (Benign Prostatic Hyperplasia),Thermotherapy

FDA Pre-Market Approval
FDA Class 3 ·PROSTATRON

Absorbable Collagen Hemostatic Agent With Thrombin

FDA Pre-Market Approval
FDA Class 3 ·HEMOBLAST™ Bellows

Lens, Multifocal Intraocular

FDA Pre-Market Approval
FDA Class 3 ·AcrySof Multifocal Intraocular Lenses

Dressing, Wound And Burn, Interactive

FDA Pre-Market Approval
FDA Class 3 ·APLIGRAF (GRAFTSKIN)

Intraocular Lens

FDA Pre-Market Approval
FDA Class 3 ·AcrySof Intraocular Lenses

Intraocular Lens

FDA Pre-Market Approval
FDA Class 3 ·Clareon Intraocular Lenses with the AutonoMe Delivery System

Dressing, Wound And Burn, Interactive

FDA Pre-Market Approval
FDA Class 3 ·APLIGRAF