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510(k) Data Aggregation

    K Number
    K993306
    Device Name
    NIKOPAD ELECTROSURGICAL GROUNDING PAD (*OR SOLD UNDER COMMERCIAL NAMES), MODEL 4760 (TYPICALLY)
    Manufacturer
    PALADIN MEDICAL, INC.
    Date Cleared
    1999-11-03

    (30 days)

    Product Code
    HAM, GEI
    Regulation Number
    878.4400
    Why did this record match?
    Applicant Name (Manufacturer) :

    PALADIN MEDICAL, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Nikomed USA electrosurgical grounding pad (sold under various commercial names through repackagers and resellers) is indicated for use with electrosurgical generators for cutting and coagulation.
    Device Description
    The Nikopad Electrosurgical Grounding Pad is a flexible, conductive adhesive electrosurgical grounding pad with integrated 3 meter transparent cable and standard US 2-female connector. The conductive area is 143 sq cm and the adhesive area is 242 sq cm. Units are packaged individually and typically sold 25 pieces to a box.
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    K Number
    K970347
    Device Name
    MPC (MODEL 7000) EXTERNAL TEMPORARY PACEMAKER SYSTEM
    Manufacturer
    PALADIN MEDICAL, INC.
    Date Cleared
    1997-08-29

    (214 days)

    Product Code
    DTE, 74D
    Regulation Number
    870.3600
    Why did this record match?
    Applicant Name (Manufacturer) :

    PALADIN MEDICAL, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The MPC Model 7000 External Temporary Pacemaker System is indicated for temporary (1-10 days typical) ventricular cardiac pacing in a controlled clinical environment.
    Device Description
    The MPC Model 7000 External Temporary Pacemaker System is a battery powered, single chamber external pacemaker. It consists of two major components: the MPC Model 3000 Programmer and the MPC Model 1000 Pulse Generator. The System also includes an MPC Model 5003 Patient Arm/Leg Strap used to secure the Pulse Generator to either the patient's arm or leg. An MPC Model 5002 Programmer Holder to store the Programmer on a wall is also available. The MPC Model 3000 Programmer transmits the pulse programming data selected by the physician for patient therapy to the MPC Model 1000 Pulse Generator by infrared telemetry. The MPC Model 1000 Pulse Generator and the MPC Model 3000 Programmer are re-usable. The MPC Model 1000 Pulse Generator and the MPC Model 3000 Programmer are designed so that they may be disinfected between patient use. The MPC Model 5003 Patient Arm/Leg Strap is disposable and labeled for single-use only.
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    K Number
    K971290
    Device Name
    STRATASYS FDM MEDMODELER SYSTEM
    Manufacturer
    PALADIN MEDICAL, INC.
    Date Cleared
    1997-06-20

    (74 days)

    Product Code
    LLZ
    Regulation Number
    892.2050
    Why did this record match?
    Applicant Name (Manufacturer) :

    PALADIN MEDICAL, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Stratasys FDM MedModeler is indicated as an image processing accessory, used to create three dimensional models from 3D surface representation data or 2D contour data as a diagnostic tool, as a pre-operative planning tool, and to enhance communication with patients, other professionals or students.
    Device Description
    The Stratasys FDM MedModeler produces anatomical models for use in a variety of medical applications using CT and MRI imaging data. The four main parts of the FDM system, as displayed in Figure 1 (previous page) are 1) the QuickSlice Software, 2) FDM Hardware, 3) Modeling Materials and a 4) Computer Workstation.
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    K Number
    K964222
    Device Name
    ACU-CLENS CLEANING SYSTEM FOR CONTACT LENS CLEANING
    Manufacturer
    PALADIN MEDICAL, INC.
    Date Cleared
    1996-12-20

    (59 days)

    Product Code
    LYL
    Regulation Number
    886.5928
    Why did this record match?
    Applicant Name (Manufacturer) :

    PALADIN MEDICAL, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    ACU-CLENS™ Cleaning Accessory is indicated for use with recommended contact lens cleaning solutions for cleaning soft (hydrophilic) and rigid gas permeable contact lenses in accordance with directions for use in the solution labeling. The device ands in cleaning by minimizing hand contact with lenses.
    Device Description
    ACU-CLENS™ Cleaning Accessory for Contact Lens Cleaning is a method of cleaning contact lenses that mimics the figure-eight hand-in-palm motion. The ACU-CLENS™ Cleaning Accessory can be used with hard (gas permeable) and soft (hydrophilic) lenses. ACU-CLENSTM Cleaning Accessory features a durable plastic case and disposable foam pads for use with professionally recommended daily cleaning solutions. The hinge mounted base and cover contain right and left lens receptacles and four mounting posts which secures the disposable pad to the base. The cover provides a motion plate, cleaning head domes and a hinged latch to secure the disposable pad to the cleaning head domes. Daily cleaning solution (recommended by an eye care professional or physician) is applied to the disposable pad secured to the cleaning head domes and the right and left receptacle and the lenses are placed on the disposable pad above the right and left receptacle. After closing the case the motion plate on the cover is moved in a figure-8 motion to create the scrubbing effect necessary to clean both top and bottom of each lens simultaneously. Lenses should be thoroughly disinfected using solution recommended by physicians or eye-care professionals. The disposable pad should be removed and the Cleaning Case disinfected after each use.
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