BEUDAMED
    FDA Registration Active 🇺🇸 United States

    BOULDER BIOMED LLC

    Reg #: 3015151147 · FEI: 3015151147 · Expires 2026
    View on FDA
    Products
    29
    Proprietary Names
    39
    Establishment Types
    2
    Classifications
    29

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    Registration Details

    Registration Name
    BOULDER BIOMED LLC
    Registration Number
    3015151147
    FEI Number
    3015151147
    Status
    Active
    Expiry Year
    2026
    Initial Importer
    No
    Address
    5421 Western Avenue
    City
    Boulder
    State
    CO
    ZIP
    80301
    Country
    US

    Owner / Operator

    Firm Name
    Boulder BioMed dba Boulder iQ
    Operator Number
    10058905
    Address
    5421 Western Avenue
    City
    Boulder
    State
    CO
    Postal Code
    80301
    Country
    US
    Correspondent
    James F Kasic

    Products

    Device Name Product Code
    Flowmeter, Blood, Cardiovascular DPW
    Intervertebral Fusion Device With Bone Graft, Lumbar MAX
    Bit, Drill HTW
    Orthopedic Augmented Reality SBF
    Device, Vascular, For Promoting Embolization KRD
    Device, Monitoring, Intracranial Pressure GWM
    Shunt, Central Nervous System And Components JXG
    Scissors, General, Surgical LRW
    Laparoscope, General & Plastic Surgery GCJ
    Powered Laser Surgical Instrument GEX
    Electrosurgical, Cutting & Coagulation & Accessories GEI
    Screw, Fixation, Bone HWC
    Pin, Fixation, Smooth HTY
    Fastener, Fixation, Nondegradable, Soft Tissue MBI
    Stimulator, Electrical, Implantable, For Incontinence EZW
    Drills, Burrs, Trephines & Accessories (Simple, Powered) HBE
    Catheter, Continuous Flush KRA
    Computer, Diagnostic, Programmable DQK
    Intervertebral Fusion Device With Integrated Fixation, Lumbar OVD
    Prosthesis, Toe, Hemi-, Phalangeal KWD
    Platelet And Plasma Separator For Bone Graft Handling ORG
    Syringe, Piston FMF
    Orthopedic Manual Surgical Instrument LXH
    Skin Resurfacing Rf Applicator OUH
    System, Imaging, Pulsed Echo, Ultrasonic IYO
    Arthroscope HRX
    Intervertebral Fusion Device With Bone Graft, Cervical ODP
    Instrument, Surgical, Orthopedic, Dc-Powered Motor And Accessory/Attachment KIJ
    Needle, Suturing, Disposable GAB

    Proprietary Names

    MBS-Series Single-Use Short-Handled Cerebrovascular Flowprobe HxxAUL-5 Ultrafit Liner Assembly MB-Series Single-Use Cerebrovascular Flowprobe aprevo TLIF-C Articulating System (TLIF-CA) Thermally Hardened Cannulated Drill Bit (various) aprevo Anterior Lumbar Interbody Fusion, aprevo Lateral Lumbar Interbody Fusion Stellar Knee Nitinol Enhanced Device (NED) IRRAflow Suture Slicer EnlightenVue Microendoscopy System Platform Wound Dressing Extremity All Suture System Neuspera Sacral Neuromodulation (SNM) System Hubly Electric Drill Xpan Universal Trocar System Angler Steerable, Deflectable Microcatheter iMap 3d Mapping and Navigation System aprevo Anterior Lumbar Fusion Device with Interfixation Accu-joint Hemi Implant Single Sterile Fibrinet Daxor MAX 100 Syringe (MAX 100) Wright-Out Hip Stem Extractor Guide Block and Osteotome Blade Kit SmartShot Wright-Out Hip Stem Extractor Tool Kit Wright-Out Hip Stem Extractor 5/64" T-Handle Hex Key Wright-Out Hip Stem Extractor Osteotome Handle Wright-Out Hip Stem Extractor Slide Hammer Wright-Out Hip Stem Extractor 10mm T-Handle Socket Wrench Guide Sleeve (various), Inserter Handle (various) Vivace Ultra/Ultra Vision RF Microneedling Device aprevo Transforaminal Lumbar Interbody Fusion TenJet Basalt Lavaflow Obsidian Lavaflow Magma Small Lavaflow Slate Laveflow Reciprocating Saw Needle (various)

    Establishment Types

    Sterilize Medical Device for Another Party (Contract Sterilizer) Manufacture Medical Device for Another Party (Contract Manufacturer)