BEUDAMED
    673 results · 27ms · Sources: EU EUDAMED, US FDA
    Filters Classification: FDA Class 3 ×

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

    FDA Pre-Market Approval
    FDA Class 3 ·DIASORIN ETI MAK-2 PLUS ASSAY

    Intraocular Lens

    FDA Pre-Market Approval
    FDA Class 3 ·CHIROFLEX MODELS 32 C10XX SILICONE POSTERIOR IOL

    Pulse-Generator, Single Chamber, Single

    FDA Pre-Market Approval
    FDA Class 3 ·CYBERTACH(TM) 60 PULSE GENERATOR & PROGRAMMER

    Device, Hemostasis, Vascular

    FDA Pre-Market Approval
    FDA Class 3 ·QUICK-CLOSE VASCULAR SUTURING SYSTEM (QUICK-CLOSE SYSTEM)

    Intraocular Lens

    FDA Pre-Market Approval
    FDA Class 3 ·HYDROVIEW COMPOSITE HYDROGEL FOLDABLE UV-ABSORBING POSTERIOR CHAMBER INTRAOCULAR LENS

    Stent, Coronary

    FDA Pre-Market Approval
    FDA Class 3 ·COBRA PzF NanoCoated Coronary Stent System

    Ligaments And Tendons, Synthetic

    FDA Pre-Market Approval
    FDA Class 3 ·KENNEDY LAD(TM) LIGAMENT AUGMENTATION DEVICE

    Lens, Contact (Rigid Gas Permeable), Extended Wear

    FDA Pre-Market Approval
    FDA Class 3 ·FLUOROCON TM-60

    Prosthesis, Knee, Femorotibial, Unicompartmental, Semi-Constrained, Metal/Polymer, Mobile Bearing

    FDA Pre-Market Approval
    FDA Class 3 ·NEW JERSEY LCS(R) TOTAL KNEE SYSTEM

    Kit, Assay, Estrogen Receptor

    FDA Pre-Market Approval
    FDA Class 3 ·FLUORO-CEP{R} ESTROGEN ASSAY REAGENT

    Sensor, Glucose, Invasive

    FDA Pre-Market Approval
    FDA Class 3 ·FREESTYLE NAVIGATOR CONTINUOUS GLUCOSE MONITOR

    Total, Prostate Specific Antigen (Noncomplexed & Complexed) For Detection Of Prostate Cancer

    FDA Pre-Market Approval
    FDA Class 3 ·Sangia Total PSA Test

    Catheter, Coronary, Atherectomy

    FDA Pre-Market Approval
    FDA Class 3 ·SIMPSON CORONARY ATHEROCATH(TM)

    Coronary Drug-Eluting Stent

    FDA Pre-Market Approval
    FDA Class 3 ·CYPHER SIROLIMUS-ELUTING CORONARY STENT ON THE RAPTOR OVER-THE-WIRE DELIVERY SYSTEM OR RAPTORRAIL RAPID EXCHANGE DELIVER

    Separator For Therapeutic Purposes, Membrane Automated Blood Cell/Plasma

    FDA Pre-Market Approval
    FDA Class 3 ·PROSORBA(TM) COLUMN

    Ventilator, High Frequency

    FDA Pre-Market Approval
    FDA Class 3 ·INFANT STAR HIGH FREQUENCY VENTILATOR

    Lens, Contact (Rigid Gas Permeable), Extended Wear

    FDA Pre-Market Approval
    FDA Class 3 ·MENICON SF-P RGP (MELAFOCON A) CONTACT LENS

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

    FDA Pre-Market Approval
    FDA Class 3 ·AXSYM CORE 2.0 AND AXSYM CORE 2.0 CONTROLS

    Absorbable Coronary Drug-Eluting Stent

    FDA Pre-Market Approval
    FDA Class 3 ·ABSORB GT1 BIORESORBABLE VASCULAR SCAFFOLD (BVS) SYSTEM

    Aortic Valve, Prosthesis, Percutaneously Delivered

    FDA Pre-Market Approval
    FDA Class 3 ·EDWARDS SAPIEN TRANSCATHETER HEART VALVE AND ACCESSORIES