BEUDAMED
    FDA Registration Active 🇺🇸 United States

    PRO-TECH DESIGN & MFG., INC.

    Reg #: 2032521 · FEI: 3003574398 · Expires 2026
    View on FDA
    Products
    61
    Proprietary Names
    10
    Establishment Types
    1
    Classifications
    61

    Registration Details

    Registration Name
    PRO-TECH DESIGN & MFG., INC.
    Registration Number
    2032521
    FEI Number
    3003574398
    Status
    Active
    Expiry Year
    2026
    Initial Importer
    No
    Address
    14561 MARQUARDT AVE.
    City
    SANTA FE SPRINGS
    State
    CA
    ZIP
    90670
    Country
    US

    Owner / Operator

    Firm Name
    PRO-TECH Design & Mfg, Inc.
    Operator Number
    9048910
    Address
    14561 MARQUARDT AVE., --
    City
    Santa Fe Springs
    State
    CA
    Postal Code
    90670
    Country
    US

    Products

    Device Name Product Code
    Laparoscope, General & Plastic Surgery GCJ
    Arthroscope HRX
    Intervertebral Fusion Device With Bone Graft, Cervical ODP
    Implantable Cardioverter Defibrillator (Non-Crt) LWS
    Permanent Defibrillator Electrodes NVY
    Needle, Conduction, Anesthetic (W/Wo Introducer) BSP
    Prosthesis, Wrist, 3 Part Metal-Plastic-Metal Articulation, Semi-Constrained JWJ
    Screw, Fixation, Bone HWC
    Washer, Bolt Nut HTN
    Syringe, Piston FMF
    Prosthesis, Shoulder, Hemi-, Humeral, Metallic Uncemented HSD
    Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer Cemented KWS
    Intervertebral Fusion Device With Bone Graft, Lumbar MAX
    Airway, Nasopharyngeal BTQ
    Dilator, Vessel, For Percutaneous Catheterization DRE
    Cover, Burr Hole GXR
    Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented LPH
    Hip Prosthesis, Semi-Constrained, Cemented, Metal/Polymer, + Additive, Porous, Uncemented OQG
    Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented LZO
    Hip, Semi-Constrained, Cemented, Metal/Ceramic/Polymer + Additive, Porous Uncemented OQI
    Prosthesis, Wrist, Hemi-, Ulnar KXE
    Device For Home Collection And Transport Of Vaginal Specimens By Lay Users For Use In An Approved Hpv Molecular Assay SEP
    Stylet, Catheter DRB
    Stimulator, Peripheral Nerve, Implanted (Pain Relief) GZF
    Dorsal Root Ganglion Stimulator For Pain Relief PMP
    Set, Administration, Intravascular FPA
    Tubes, Vials, Systems, Serum Separators, Blood Collection JKA
    Prosthesis, Toe, Hemi-, Phalangeal KWD
    Knife, Ophthalmic HNN
    Laparoscope, Gynecologic (And Accessories) HET
    Stimulator, Autonomic Nerve, Implanted For Stroke Rehabilitation QPY
    Appliance, Fixation, Nail/Blade/Plate Combination, Multiple Component KTT
    Implantable Pulse Generator, Pacemaker (Non-Crt) LWP
    Pulse Generator, Permanent, Implantable NVZ
    Programmer, Pacemaker KRG
    Pulse Generator, Pacemaker, Implantable, With Cardiac Resynchronization (Crt-P) NKE
    Defibrillator, Automatic Implantable Cardioverter, With Cardiac Resynchronization (Crt-D) NIK
    Implantable Pacemaker Pulse-Generator DXY
    Pacemaker/Icd/Crt Non-Implanted Components OSR
    Permanent Pacemaker Electrode DTB
    Drug Eluting Permanent Right Ventricular (Rv) Or Right Atrial (Ra) Pacemaker Electrodes NVN
    Endoscope, Flexible GCQ
    Intervertebral Fusion Device With Integrated Fixation, Lumbar OVD
    Orthosis, Spinal Pedicle Fixation MNI
    Orthosis, Spondylolisthesis Spinal Fixation MNH
    Appliance, Fixation, Spinal Interlaminal KWP
    Drug Eluting Permanent Left Ventricular (Lv) Pacemaker Electrode OJX
    Medical Glove, Specialty LZC
    Monitor, Pressure, Intracompartmental LXC
    Prosthesis, Hip, Hemi-, Femoral, Metal/Polymer, Cemented Or Uncemented KWY
    Stimulator, Spinal-Cord, Totally Implanted For Pain Relief LGW
    Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer + Additive/Metal/Polymer + Additive OIY
    Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer JWH
    Probe, Radiofrequency Lesion GXI
    Aspiration Thrombectomy Catheter QEZ
    Stimulator, Spinal-Cord, Implanted (Pain Relief) GZB
    Hysteroscope Accessories NWW
    Knife, Intraocular Pressure Lowering QUQ
    Centrifuges (Micro, Ultra, Refrigerated) For Clinical Use JQC
    Garment, Storage, Peritoneal Dialysis Catheter OAG
    Adaptor, Holder, Syringe IQG

    Proprietary Names

    Piston Syringe VETRUN - Pre-Lubricated Nasopharyngeal Airway, Made in USA Metatarsal Decompression Implant Hemiphalangeal Implant System Xenoscope SurgView Integrated Visualization System Nimbus MY01-0001 MY01 Continuous Compartmental Pressure Monitor AbbVie Chest Pack, AbbVie Cross Body Pack, AbbVie Hip Pack, AbbVie Lightweight Vest, AbbVie Snug Vest Abbvie Fitted Vests and Belts

    Establishment Types

    Manufacture Medical Device for Another Party (Contract Manufacturer)