BEUDAMED
    650 results · 19ms · Sources: EU EUDAMED, US FDA
    Filters Classification: FDA Class 3 ×

    Valve, Pulmonary

    FDA Pre-Market Approval
    FDA Class 3 ·Zephyr Endobronchial Valve System

    Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Ceramic/Metal, Cemented Or Uncemented

    FDA Pre-Market Approval
    FDA Class 3 ·R3 Delta Ceramic Acetabular System

    Occluder, Patent Ductus, Arteriosus

    FDA Pre-Market Approval
    FDA Class 3 ·AMPLATZER Duct Occluder II

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

    FDA Pre-Market Approval
    FDA Class 3 ·ARCHITECT AUSAB Reagent, ARCHITECT AUSAB Reagent Kit, Alinity i Anti-HBs Reagent Kit

    Cap, Cooling (Infants)

    FDA Pre-Market Approval
    FDA Class 3 ·OLYMPIC COOL-CAP SYSTEM

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

    FDA Pre-Market Approval
    FDA Class 3 ·MENTOR MemoryShape Breast Implants

    Pump, Infusion, Implanted, Programmable

    FDA Pre-Market Approval
    FDA Class 3 ·CODMAN 3000 CONSTANT-FLOW IMPLANTABLE INFUSION PUMP

    Ventilator, High Frequency

    FDA Pre-Market Approval
    FDA Class 3 ·3100 High Frequency Oscillating Ventilator (HFOV), Vyaire Model 31008 Oscillatory Ventilator

    Agent, Absorbable Hemostatic, Collagen Based

    FDA Pre-Market Approval
    FDA Class 3 ·Helistaf® and Helitene® Absorbable Collagen Hemostatic Agents

    Prosthesis, Ankle, Uncemented, Non-Constrained

    FDA Pre-Market Approval
    FDA Class 3 ·Scandinavian Total Ankle Replacement (STAR)

    Defibrillator, Implantable, Dual-Chamber

    FDA Pre-Market Approval
    FDA Class 3 ·LUMOS VR/DR (-T) AND LEXOS DR/VR (-T) ICD'S

    Defibrillator, Implantable, Dual-Chamber

    FDA Pre-Market Approval
    FDA Class 3 ·LUMAX VR/DR/HF (-T) ICD'S & CRT-D'S

    Barrier, Absorbable, Adhesion

    FDA Pre-Market Approval
    FDA Class 3 ·SEPRAFILM(R) BIORESORBABLE MEMBRAND

    Spinal Pedicle Screw, Fixation, Appliance System

    FDA Pre-Market Approval
    FDA Class 3 ·LUMBAR I/F CAGE(R) SYSTEM

    Neuromodulator For Obesity

    FDA Pre-Market Approval
    FDA Class 3 ·MAESTRO RECHARGEABLE SYSTEM

    Implant, Dermal, For Aesthetic Use

    FDA Pre-Market Approval
    FDA Class 3 ·RADIESSE, 1.3 CC AND 0.3 CC

    Implant, Dermal, For Aesthetic Use

    FDA Pre-Market Approval
    FDA Class 3 ·RADIESSE, 1.3 CC AND 0.3 CC

    Diagnostic Low Electric Field

    FDA Pre-Market Approval
    FDA Class 3 ·MarginProbe System

    Intraocular Lens

    FDA Pre-Market Approval
    FDA Class 3 ·STAAR SURGICAL ELASTIMIDE ULTRAVIOLET-ABSORBING SILICONE THREE-PIECE POSTERIOR CHAMBER INTRAOCULAR LENS

    Implant, Intragastric For Morbid Obesity

    FDA Pre-Market Approval
    FDA Class 3 ·LAP-BAND ADJUSTABLE GASTRIC BANDING SYSTEM