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510(k) Data Aggregation

    K Number
    K051487
    Device Name
    DRG LARYNGEAL AUGMENTATION IMPLANT DEVICE
    Manufacturer
    DOCTOR'S RESEARCH GROUP, INC.
    Date Cleared
    2005-12-22

    (199 days)

    Product Code
    KHJ
    Regulation Number
    874.3620
    Why did this record match?
    Applicant Name (Manufacturer) :

    DOCTOR'S RESEARCH GROUP, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The DRG Laryngeal Augmentation Implant Device is indicated for use in moreations for other inn for treatment of patients with unilateral vocal cord paralysis.
    Device Description
    Laryngeal Augmentation Implant
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    K Number
    K041018
    Device Name
    DRG SOFTRELEASE
    Manufacturer
    DOCTOR'S RESEARCH GROUP, INC.
    Date Cleared
    2004-10-18

    (181 days)

    Product Code
    HHT
    Regulation Number
    884.4530
    Why did this record match?
    Applicant Name (Manufacturer) :

    DOCTOR'S RESEARCH GROUP, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    DRG SoftRelease is intended for the collection of cervical cells for Pap smear analysis and/or for detecting sexually transmitted disease (STD). DRG SoftRelease is not intended for use in pregnant women.
    Device Description
    The DRG SoftRelease is a single use, disposable, manual gynecological device intended for the collection of cervical cells for Pap smear analysis and/or for detecting sexually transmitted disease (STD). The device consists of a handle with a release mechanism, a spatula disc, and a brush. The common handle / release combination allows the attachment of a brush attachment for use in cervical or vaginal wall cell collection. The attachment of either the spatula or the brush allows for the release of the cell collector attachments from the device handle. The brush is composed of bristles joined to a wire shaft. For collecting cervical cells, the brush is inserted into the cervix until only the last row of bristles are visible, rotated once via the handle, and removed from the site for transfer of the cytological material. The spatula is made of plastic and is curve-shaped, similar to the widely used Ayre spatula. For collecting cervical cells, the spatula's blunt edge is placed against the cervix, rotated with gentle pressure on the handle, and removed from the site for transfer of the cytological material.
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    K Number
    K012535
    Device Name
    DRG DISPOSABLE VAGINAL SPECULUM
    Manufacturer
    DOCTOR'S RESEARCH GROUP, INC.
    Date Cleared
    2002-03-01

    (206 days)

    Product Code
    HIB
    Regulation Number
    884.4530
    Why did this record match?
    Applicant Name (Manufacturer) :

    DOCTOR'S RESEARCH GROUP, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The DRG Disposable Vaginal Speculum is indicated for use to expose the interior of the vagina. The DRG Disposable Vaginal Speculum is indicated for diagnostic procedures of the vagina and cervix.
    Device Description
    The DRG Disposable Vaginal Speculum consists of a plastic inflatable bladder The DNO Disposable Vaginal of to uniformly press the vaginal walls open.
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    K Number
    K012003
    Device Name
    DRG REACTION CHAMBER/SAFETY TIP
    Manufacturer
    DOCTOR'S RESEARCH GROUP, INC.
    Date Cleared
    2002-02-12

    (230 days)

    Product Code
    HEI, GEI
    Regulation Number
    884.2660
    Why did this record match?
    Applicant Name (Manufacturer) :

    DOCTOR'S RESEARCH GROUP, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The DRG Reaction Chamber/Safety Tip is indicated for use as an accessory to standard ablation electrosurgical wands which do not have irrigation and vacuum extraction attached to them. The device provides continuous irrigation and vacuum extraction at the ablation site.
    Device Description
    The DRG Reaction Chamber/Safety Tip is an accessory for Coblation® electrosurgical devices. It creates a sealed chamber during ablation, ensuring continuous liquid supply and suction.
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    K Number
    K011736
    Device Name
    DRG QUICKMIX
    Manufacturer
    DOCTOR'S RESEARCH GROUP, INC.
    Date Cleared
    2002-01-30

    (239 days)

    Product Code
    GXP, FWP
    Regulation Number
    882.5300
    Why did this record match?
    Applicant Name (Manufacturer) :

    DOCTOR'S RESEARCH GROUP, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    QuickMix is indicated for use in mixing BoneSource® Hydroxyapatite Cement and sodium phosphate solution. BoneSource is indicated for use in the repair of neurosurgical burr holes, contiguous craniotomy cuts and other cranial defects with a surface area no larger than 25 cm2 per defect, and for augmentation or restoration of bony contours in the craniofacial skeleton including the frontoorbital maler and mental areas.
    Device Description
    The DRG QuickMix mixing system consists of a syringe containing a 0.25 M sodium phosphate solution and a mixing syringes containing BoneSource® Hydroxyapatite Cement. The mixing syringe also contains a filter which allows liquid, but not the cement mixture, to pass through it. The sodium phosphate and cement mixing syringes are first connected tip to tip. The sodium phosphate solution is then injected into the mixing syringes and the cement mixture is shaken to thoroughly blend it. Excess liquid is then pulled from the mixing chamber through the filter assembly by retracting the solution plunger. The two syringes are then disconnected. The filter cap is then removed from the mixing syringe and the mixture is eiected.
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    K Number
    K013786
    Device Name
    DRG ORTHOHEX SS BONE SCREW
    Manufacturer
    DOCTOR'S RESEARCH GROUP, INC.
    Date Cleared
    2001-12-17

    (33 days)

    Product Code
    HWC
    Regulation Number
    888.3040
    Why did this record match?
    Applicant Name (Manufacturer) :

    DOCTOR'S RESEARCH GROUP, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The DRG OrthoHex SS bone screws are intended for orthopedic trauma and reconstruction.
    Device Description
    DRG OrthoHex SS Bone Screw
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    K Number
    K002047
    Device Name
    DRG PURETONE STETHOSCOPE WITH DRG ANTIMICROBIAL, STETHOSCOPE DIAPHRAGM, MODEL PT2B27(CARDIOLOGY), PT3B27(CLASSIC), PT5B2
    Manufacturer
    DOCTOR'S RESEARCH GROUP, INC.
    Date Cleared
    2000-11-22

    (139 days)

    Product Code
    DQD
    Regulation Number
    870.1875
    Why did this record match?
    Applicant Name (Manufacturer) :

    DOCTOR'S RESEARCH GROUP, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Device Description
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    K Number
    K991714
    Device Name
    DRG CONVENTIONAL ELECTRONIC DIGITAL STETHOSCOPE, MODEL ECHOP 200-00
    Manufacturer
    DOCTOR'S RESEARCH GROUP, INC.
    Date Cleared
    1999-12-10

    (204 days)

    Product Code
    DQD, DOD
    Regulation Number
    870.1875
    Why did this record match?
    Applicant Name (Manufacturer) :

    DOCTOR'S RESEARCH GROUP, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The DRG Conventional Electronic Digital Stethoscope can be used as a standard stethoscope or as an electronic digital stethoscope. The additional stethoscope features allow the user to digitally record, amplify or replay sounds associated with the heart, artery, veins and other internal organs. The sounds can be replayed at different speeds.
    Device Description
    Conventional Electronic Digital Stethoscope
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    K Number
    K990212
    Device Name
    LOCKJAW 15 MINUTE INTERMAXILLARY FIXATION SYSTEM,MODEL LJ100-00
    Manufacturer
    DOCTOR'S RESEARCH GROUP, INC.
    Date Cleared
    1999-09-14

    (235 days)

    Product Code
    DYX
    Regulation Number
    872.4600
    Why did this record match?
    Applicant Name (Manufacturer) :

    DOCTOR'S RESEARCH GROUP, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The DRG LockJaw™ 15 Minute Intermaxillary Fixation System is intended for secondary intermaxillary fixation in the treatment of maxillary and mandibular fractures, in elective orthognathic surgery and in the stabilization of dental and dentoalveolar injuries.
    Device Description
    DRG LockJaw™ 15 Minute Intermaxillary Fixation System
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    K Number
    K990920
    Device Name
    DRG TITANIUM BONE PLATE
    Manufacturer
    DOCTOR'S RESEARCH GROUP, INC.
    Date Cleared
    1999-06-10

    (84 days)

    Product Code
    JEY
    Regulation Number
    872.4760
    Why did this record match?
    Applicant Name (Manufacturer) :

    DOCTOR'S RESEARCH GROUP, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    DRG Ti Bone Plates are intended for craniofacial and mandibular trauma and reconstruction.
    Device Description
    DRG Titanium Bone Plate
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