BEUDAMED
    FDA Registration Active 🇺🇸 United States

    Heraeus Medical LLC

    Reg #: 3013186738 · FEI: 3013186738 · Expires 2026
    View on FDA
    Products
    10
    Proprietary Names
    35
    Establishment Types
    1
    Classifications
    10

    Registration Details

    Registration Name
    Heraeus Medical LLC
    Registration Number
    3013186738
    FEI Number
    3013186738
    Status
    Active
    Expiry Year
    2026
    Initial Importer
    Yes
    Address
    Township Line Road 770, Suite 300
    City
    Yardley
    State
    PA
    ZIP
    19067
    Country
    US

    Regulatory Submissions

    510(k) Number
    K142157

    Owner / Operator

    Firm Name
    Heraeus Medical GmbH
    Operator Number
    10048423
    Address
    Philipp-Reis-Str. 8/13
    City
    Wehrheim
    State
    Hesse
    Postal Code
    61273
    Country
    DE
    Correspondent
    Benjamin Hagedorn

    Products

    Device Name Product Code
    Dispenser, Cement KIH
    Bone Cement, Antibiotic MBB
    Mixer, Cement, For Clinical Use JDZ
    Bone Cement LOD
    Prosthesis, Hip, Hemi-, Femoral, Metal KWL
    Prosthesis, Hip, Hemi-, Femoral, Metal/Polymer, Cemented Or Uncemented KWY
    Cement, Bone, Vertebroplasty NDN
    Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer JWH
    Evacuator, Vapor, Cement Monomer JDY
    Template HWT

    Proprietary Names

    PALACOS® R+G pro PALACOS® R+G Palacos G OSTEOPAL V Palamed® G PALACOS® MV+G PALACOS® R pro PALACOS® MV+G pro PALACOS® fast R+G Palacos® R COPAL® exchange G PALACOS® MV pro PALAMIX Cement Gun PALAMIX Nozzle Slim PALAMIX Nozzle Medium pro nozzle medium pro nozzle short with knee pressuriser PALAMIX UNO PALAMIX DUO COPAL exchange G hip spacer PALAMIX vacuum pump PALACOS MV COPAL® exchange G Trial Sets COPAL® knee mould Trial S US COPAL® knee mould Trial L US COPAL® knee mould Trial M US Palamed® PALACOS® MV PALACOS R pro Palacos LV® + G Osteopal® V PALACOS® R OSTEOPAL® plus PALACOS® LV Osteopal®

    Establishment Types

    Complaint File Establishment per 21 CFR 820.198