BEUDAMED
    3,496 results · 25ms · Sources: EU EUDAMED, US FDA
    Filters Classification: FDA Class 3 ×

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

    FDA Pre-Market Approval
    FDA Class 3 ·DIMENSIONS TPSA FLE REAGENT CARTRIDGE

    Gonococcal Antibody Tests

    FDA Pre-Market Approval
    FDA Class 3 ·FLUORESCENT GONORRHEA TEST-HEATED (FGT-H)

    Device, Thermal Ablation, Endometrial

    FDA Pre-Market Approval
    FDA Class 3 ·Cerene Cryotherapy Device (Model Number FGS-7000)

    Gastric Emptying Breath Test

    FDA Pre-Market Approval
    FDA Class 3 ·13C-Spirulina Gastric Emptying Breath Test (GEBT)

    Gastric Emptying Breath Test

    FDA Pre-Market Approval
    FDA Class 3 ·13C-Gastric Emptying Breath Test (GEBT), 13C-Spirulina Gastric Emptying Breath Test (GEBT), 13C-GEBT

    Gastric Emptying Breath Test

    FDA Pre-Market Approval
    FDA Class 3 ·13C-Spirulina Gastric Emptying Breath Test (GEBT)

    Gastric Emptying Breath Test

    FDA Pre-Market Approval
    FDA Class 3 ·GASTRIC EMPTYING BREATH TEST (GEBT)

    Gastric Emptying Breath Test

    FDA Pre-Market Approval
    FDA Class 3 ·13C-SPIRULINA GEBT/13C-SPIRULINA GASTRIC EMPTYING BREATH TEST (GEBT)

    Gastric Emptying Breath Test

    FDA Pre-Market Approval
    FDA Class 3 ·13C-Spirulina Gastric Emptying Breath Test (GEBT)

    Gastric Emptying Breath Test

    FDA Pre-Market Approval
    FDA Class 3 ·13 C-Spirulina Gastric Emptying Breath Test (GEBT)

    Gastric Emptying Breath Test

    FDA Pre-Market Approval
    FDA Class 3 ·13C-Spirulina Gastric Emptying Breath Test (GEBT)

    Gastric Emptying Breath Test

    FDA Pre-Market Approval
    FDA Class 3 ·13 C-SPIRULINA GASTRIC EMPTYING BREATH TEST (GEBT)

    Mycobacterium Tuberculosis, Cell Mediated Immune Response, Enzyme-Linked Immunospot Test

    FDA Pre-Market Approval
    FDA Class 3 ·T SPOT-TB Test

    Defibrillator, Automatic Implantable Cardioverter, With Cardiac Resynchronization (Crt-D)

    FDA Pre-Market Approval
    FDA Class 3 ·EPIC HF/ATLAS + HF FAMILY OF CRT-DS

    Pulse Generator, Permanent, Implantable

    FDA Pre-Market Approval
    FDA Class 3 ·CADENCE FAMILY OF ICDS

    Iliac Covered Stent, Arterial

    FDA Pre-Market Approval
    FDA Class 3 ·LifeStream Balloon Expandable Vascular Covered Stent

    Implant, Dermal, For Aesthetic Use

    FDA Pre-Market Approval
    FDA Class 3 ·Restylane Lyft with Lidocaine Cannula Injection

    Implant, Dermal, For Aesthetic Use

    FDA Pre-Market Approval
    FDA Class 3 ·JUVEDERM VOLUMA XC

    Catheter, Coronary, Atherectomy

    FDA Pre-Market Approval
    FDA Class 3 ·Rotablator™ and ROTAPRO™ Rotational Atherectomy Systems

    System, Laser, Transmyocardial Revascularization

    FDA Pre-Market Approval
    FDA Class 3 ·HEART LASER CO2 TMR SYSTEM