BEUDAMED
    10,000 results · 36ms · Sources: EU EUDAMED, US FDA
    Filters Classification: FDA Class 3 ×

    Implantable Cardioverter Defibrillator (Non-Crt)

    FDA Pre-Market Approval
    FDA Class 3 ·Implantable Cardioverter Defibrillator (Non-CRT)

    Automated External Defibrillators (Non-Wearable)

    FDA Pre-Market Approval
    FDA Class 3 ·Defibtech's Automated External Defibrillator (AED) System

    Test, Immunity, Cell Mediated, Mycobacterium Tuberculosis

    FDA Pre-Market Approval
    FDA Class 3 ·LIAISON QuantiFERON - TB Gold Plus, LIAISON Control QuantiFERON - TB Gold Plus and LIAISON QuantiFERON Software

    Sealant, Polymerizing

    FDA Pre-Market Approval
    FDA Class 3 ·PROGEL Pleural Air Leak Sealant (PALS); PROGEL Spare Tips accessory; PROGEL 6 Extended Tips accessory; PROGEL 11 Extende

    Stent, Coronary

    FDA Pre-Market Approval
    FDA Class 3 ·PRO-Kinetic Energy Coronary Stent System, Papyrus

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

    FDA Pre-Market Approval
    FDA Class 3 ·TARGIS SYSTEM

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

    FDA Pre-Market Approval
    FDA Class 3 ·MOBILE PROSTATRON

    Temporary Non-Roller Type Left Heart Support Blood Pump

    FDA Pre-Market Approval
    FDA Class 3 ·Impella 2.5, Impella CP, Impelia CP with SmartAssist, Impella 5.0, Impella 5.5 with SmartAssist and Impella LD

    Implantable Cardioverter Defibrillator (Non-Crt)

    FDA Pre-Market Approval
    FDA Class 3 ·Epsila EV Extravascular Lead (EV2401)

    Stimulator, Bone Growth, Non-Invasive

    FDA Pre-Market Approval
    FDA Class 3 ·OL1000 DUAL COIL MEDIUM BONE GROWTH STIMULATION DEVICE

    Pulse Generator, Permanent, Implantable

    FDA Pre-Market Approval
    FDA Class 3 ·KAPPA 400

    Lenses, Soft Contact, Extended Wear

    FDA Pre-Market Approval
    FDA Class 3 ·BIOFINITY (COMFILCON A) SOFT (HYDROPHILIC) EXTENDED-WEAR CONTACT LENSES

    Barrier, Absorbable, Adhesion

    FDA Pre-Market Approval
    FDA Class 3 ·GYNECARE INTERCEED™ Absorbable Adhesion Barrier

    Pulse Generator, Permanent, Implantable

    FDA Pre-Market Approval
    FDA Class 3 ·VARIOUS FAMILIES OF PACEMAKERS

    Drug Eluting Permanent Left Ventricular (Lv) Pacemaker Electrode

    FDA Pre-Market Approval
    FDA Class 3 ·ATTAIN OTW/ATTAIN LV LEAD/ATTAIN CS LEAD

    Stimulator, Electrical, Implanted, For Parkinsonian Tremor

    FDA Pre-Market Approval
    FDA Class 3 ·MEDTRONIC ACTIVA TREMOR CONTROL SYSTEM

    Placental Alpha Microglobulin-1 Immunoassay

    FDA Pre-Market Approval
    FDA Class 3 ·PartoSure Test

    Agent, Absorbable Hemostatic, Collagen Based

    FDA Pre-Market Approval
    FDA Class 3 ·Gel-Flow NT, Gelfoam Powder, Gelfoam Sponge, Gelfoam Compressed Sponge

    Coronary Drug-Eluting Stent

    FDA Pre-Market Approval
    FDA Class 3 ·ORSIRO Mission Sirolimus Eluting Coronary Stent System

    Implantable Pacemaker Pulse-Generator

    FDA Pre-Market Approval
    FDA Class 3 ·PSW 1801.U