BEUDAMED
    2,489 results · 19ms · Sources: EU EUDAMED, US FDA
    Filters Classification: FDA Class 3 ×

    Aid, Surgical, Viscoelastic

    FDA Pre-Market Approval
    FDA Class 3 ·DISCOVISC™ Ophthalmic Viscosurgical Device

    Sealant, Dural

    FDA Pre-Market Approval
    FDA Class 3 ·DURASEAL DURAL SEALANT SYSTEM

    Automated External Defibrillators (Non-Wearable)

    FDA Pre-Market Approval
    FDA Class 3 ·HeartSine Technologies LLC's samaritan Public Access Automated External Defibrillators (SAM 350P, SAM 360P and SAM 450P)

    Automated External Defibrillators (Non-Wearable)

    FDA Pre-Market Approval
    FDA Class 3 ·HeartSine Technologies LLC's samaritan Public Access Automated External Defibrillators (SAM 350P, SAM 360P and SAM 450P)

    Automated External Defibrillators (Non-Wearable)

    FDA Pre-Market Approval
    FDA Class 3 ·HeartSine Technologies LLC's samaritan Public Access Automated External Defibrillators (SAM 350P, SAM 360P and SAM 450P)

    Automated External Defibrillators (Non-Wearable)

    FDA Pre-Market Approval
    FDA Class 3 ·HeartSine Technologies LLC's samaritan Public Access Automated External Defibrillators (SAM 350P, SAM 360P and SAM 450P)

    Stimulator, Bone Growth, Non-Invasive

    FDA Pre-Market Approval
    FDA Class 3 ·OL1000/OL1000 SC AND SPINALOGIC BONE BROWTH STIMULATORS

    Sealant, Polymerizing

    FDA Pre-Market Approval
    FDA Class 3 ·PreveLeak Surgical Sealant & 10pk applictor tips

    Stent, Urethral, Prostatic, Semi-Permanent

    FDA Pre-Market Approval
    FDA Class 3 ·THE SPANNER TEMPORARY PROSTATIC STENT

    Implant, Cochlear

    FDA Pre-Market Approval
    FDA Class 3 ·Neuro Cochlear Implant System

    Device, Hemostasis, Vascular

    FDA Pre-Market Approval
    FDA Class 3 ·MYNX VASCULAR CLOSURE DEVICE PRODUCT FAMILY

    Aid, Surgical, Viscoelastic

    FDA Pre-Market Approval
    FDA Class 3 ·OCUCOAT (2% HYDROXPROPYLMETHYLCELLULOSE SOLUTION)

    Multi-Analyte Test System With Algorithmic Analysis For Detection Of Prostate Cancer

    FDA Pre-Market Approval
    FDA Class 3 ·4Kscore Test

    Pulse Generator, Permanent, Implantable

    FDA Pre-Market Approval
    FDA Class 3 ·ENTOVIS, EVIA, ESTELLA, EFFECTA, ECURO, DEXTRUS, SETROX, SELOX, TILDA, P-KIT, SAFIO, SLX, CARDIOMESSENGER LLT KIT, ICS

    Device, Dermal Replacement

    FDA Pre-Market Approval
    FDA Class 3 ·INTEGRA DERMAL REGENERATION TEMPLATE - TERMINALLY STERILIZED (IDRT-TS)

    Excimer Laser System

    FDA Pre-Market Approval
    FDA Class 3 ·STAT S4 IR EXCIMER LASER SYSTEM WITH VARIABLE SPOT SCANNING (VSS) AND WAVESCAN WAVEFRONT SYSTEM

    Lens, Multifocal Intraocular

    FDA Pre-Market Approval
    FDA Class 3 ·ARRAY MULTIFOCAL ULTRAVIOLET ABSORBING SILICONE POSTERIOR CHAMBER IOL

    Intraocular Lens

    FDA Pre-Market Approval
    FDA Class 3 ·ALLERGAN SENSAR SOFT ACRYLIC UV-LIGHT ABSORBING POSTERIOR CHAMBER IOL

    Mitral Valve Repair Devices

    FDA Pre-Market Approval
    FDA Class 3 ·MITRACLIP CLIP DELIVERY SYSTEM AND MITRACLIP STEERABLE GUIDE CATHETER

    Sealant, Polymerizing

    FDA Pre-Market Approval
    FDA Class 3 ·ETHICON OMNEX SURGICAL SEALANT