BEUDAMED
    FDA Registration Active 🇺🇸 United States

    TZ MEDICAL, INC.

    Reg #: 3027815 · FEI: 1000127185 · Expires 2026
    View on FDA
    Products
    28
    Proprietary Names
    102
    Establishment Types
    4
    Classifications
    28

    Registration Details

    Registration Name
    TZ MEDICAL, INC.
    Registration Number
    3027815
    FEI Number
    1000127185
    Status
    Active
    Expiry Year
    2026
    Initial Importer
    No
    Address
    20497 Sw Teton Ave
    City
    Tualatin
    State
    OR
    ZIP
    97062
    Country
    US

    Regulatory Submissions

    510(k) Number
    K053590
    PMA Number
    P200005

    Owner / Operator

    Firm Name
    TZ MEDICAL, INC.
    Operator Number
    9006202
    Address
    20497 SW Teton Avenue, Suite A, --
    City
    Tualatin
    State
    OR
    Postal Code
    97062
    Country
    US
    Correspondent
    John - Lubisich

    Products

    Device Name Product Code
    Dressing, Wound, Drug FRO
    Holder, Ureteral Catheter EYJ
    Introducer, Catheter DYB
    Tape, Measuring, Rulers And Calipers FTY
    Catheter, Electrode Recording, Or Probe, Electrode Recording DRF
    Shield, Protective, Personnel KPY
    Device, Intravascular Catheter Securement KMK
    Instrument, Surgical, Disposable KDC
    Table And Attachments, Operating-Room BWN
    Apron, Protective IWO
    Tape And Bandage, Adhesive KGX
    Holder, Head, Neurosurgical (Skull Clamp) HBL
    Radiographic Protective Glove IWP
    Adaptor, Stopcock, Manifold, Fitting, Cardiopulmonary Bypass DTL
    Syringe, Balloon Inflation MAV
    Clamp, Vascular DXC
    Automated External Defibrillators (Non-Wearable) MKJ
    Electrode, Pacemaker, Temporary LDF
    Retractor GAD
    Transmitters And Receivers, Electrocardiograph, Telephone DXH
    Dressing, Compression MHW
    Detector And Alarm, Arrhythmia DSI
    Tape, Orthopedic HXT
    Cable, Transducer And Electrode, Patient, (Including Connector) DSA
    Support, Patient Position CCX
    Hemostatic Wound Dressing Without Thrombin Or Other Biologics QSY
    Monitor, Bed Patient KMI
    Trocar DRC

    Proprietary Names

    SilverStat ATS Adaptable Tensioning System TZ Thin-Wall Radial Sheath Shoot'N"See CS-H-14-10 - Cable CF-D7-AAA-NSDA Comfort Shield Radiation Attenuation Headband Flipper HALO FLIPPER URPRO PERIPHERAL FLIPPER EZ Holder TZ Distraction Pin RADIAL RUNWAY Apron Leaded Vest Leaded Thiroid Colar AD-SKIN Skull Pin Adult Radiation Protective Gloves IDD-0020 IDD-0010 PTCA Kit AccuFlate Inflation Device QuicKlamp P-122-T1, Sterile P-214-Z1, Zoll P-224-Z1, Zoll, Sterile P-224-T1, Sterile P-214-M1, Medtronic P-214-T1 P-311-T1 Multi-Function Defibrillator Electrodes Adult P-212-Z1, Zoll P-111-Z1, Zoll P-211-M1, Medtronic P-111-M1, Medtronic P-122-Z1 , Zoll, Sterile Multi-Function Defibrillator Electrodes Adult - Sterile P-311-M1, Medtronic P-121-Z1, Zoll, Sterile P-212-M1, Medtronic P-311-Z1, Zoll Multi-Function Defibrillator Electrodes Pediatric Multi-Function Defibrillator Electrodes Pediatric - Sterile P-112-T1 P-211-Z1, Zoll P-111-T1 P-211-T1 Defibrillation Electrodes P-121-T1, Sterile TruBrite Heart Aide ARC Band Comfort Band Radial Comfort Band Radial Adjustable Comfort Band EZ BAND ROC Band TZ Disc TZ Pressure Dics EZ HOLD EZ Pace Ultra Pace Aera LifeSense Clarus 40 Aera CT Trident Nano Trident Pro Trident Holter Trident 30 Trident 40 LTE CARDIOSENTRY PULLIE Pannus Retention System (PRS) Panni XL (PPR) V1-PATIENT COMPANION V1 PADTAC Cables and Adapters Comfort Cloud Comfort Zone Body Wrap Rad Stop Cobra Board Comfort Zone Patient Immobilizer Comfort Cradle Radial Board NEPTUNE PRODUCTS: PAD COMFORT BANDS DISC Neptune Plus Neptune Pad Neptune e-neptune pad Neptune Comfort Band Neptune Disc FM Demodulator Anti-Fatigue Floor Mat TZ Anti-Fatigue Mat Anti-Fatigue Standing Mat TZ Transseptal Needle

    Establishment Types

    Repack or Relabel Medical Device Manufacture Medical Device Develop Specifications But Do Not Manufacture At This Facility Manufacture Medical Device for Another Party (Contract Manufacturer)