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Company Name Brand Name GMDN Term Name GMDN Term Status FDA Product Code Name FDA Product Code Device Packaged As Sterile Sterilization Prior To Use Issuing Agency Device Size Device Size Type Device Class Implantable

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Southmedic Surgical Retainer Large
Southmedic Incorporated
CWKSR-L
In Commercial Distribution

  • 10620974001918 ()
CWKSR-L

  • Skin-closing tension device
Southmedic Surgical Retainer Small
Southmedic Incorporated
CWKSR-S
In Commercial Distribution

  • 10620974001932 ()
CWKSR-S

  • Skin-closing tension device
Captive Screw, Drill Guide
Stryker GmbH
908-0110-02
In Commercial Distribution

  • 00886385017365 ()
908-0110-02

  • Surgical drill guide, reusable
PCM Guide, Spacer Wedge
Nuvasive, Inc.
7670110
In Commercial Distribution

  • 00887517076502 ()


  • Surgical drill guide, reusable
PCM Guide, Spacer Wedge
Nuvasive, Inc.
7670108
In Commercial Distribution

  • 00887517075994 ()


  • Surgical drill guide, reusable
PCM Guide, Distraction Screw
Nuvasive, Inc.
7670100
In Commercial Distribution

  • 00887517075987 ()


  • Surgical drill guide, reusable
The EXOGEN device provides non-invasive therapy for healing non-unions and accelerating time to healing of fresh fractures. The EXOGEN Ultrasound Bone Healing Systems has been designed both for use with conservatively treated fresh fractures and non-unions or surgically treated non-unions. The device transmits a low intensity ultrasound signal to the fracture site through coupling gel, with little or no sensation felt by the patient during the treatment. The low-intensity pulsed ultrasound has been shown in in-vitro and in-vivo studies to stimulate cells to produce growth factors and proteins that are important to bone healing. The patient administers treatment at home or at work, once daily, for 20 minutes, or as prescribed by a physician. The device automatically alerts the patient in case of improper application or device performance. The EXOGEN Ultrasound Bone Healing System consists of one main operating unit, gel bottles and strap. The main operating unit provides the treatment control circuitry, the primary battery supply, and monitors the operation of the transducer at the fracture site. The signal specifications cannot be changed.
BIOVENTUS LLC
71034600
In Commercial Distribution

  • M937710346001 ()
71034600

  • Bone growth ultrasonic stimulator
  • Radiographic image marker, manual
  • Skin topical coupling gel
  • Personal device holder, single-use
Hyalgan® Sodium Hylauronate (20mg/2mL) in the 2mL vial is indicated for the treatment of pain in osteoarthritis (OA) of the knee in patients who have failed to respond adequately to conservative nonpharmacologic therapy and to simple analgesics, e.g., acetaminophen. It is a viscous solution of purified natural Sodium Hylauronate (Hyalectin®) in buffered physiological sodium chloride. The sodium hylauronate is extracted from rooster combs. It is given by intra-articular injection in a treatment cycle consisting of five injections given at weekly intervals. Some patients may experience benefit with three injections given at weekly cycles. This has been noted in studies reported in the literature in which patients treated with three injections were followed for 60 days.
FIDIA FARMACEUTICI SPA
89122-0724-12
Not in Commercial Distribution

  • M71389122072412A1 ()
89122-0724-12

  • Synovial fluid supplementation medium
Hyalgan® Sodium Hylauronate (20mg/2mL) in the 2mL syringe is indicated for the treatment of pain in osteoarthritis (OA) of the knee in patients who have failed to respond adequately to conservative nonpharmacologic therapy and to simple analgesics, e.g., acetaminophen. It is a viscous solution of purified natural Sodium Hylauronate (Hyalectin®) in buffered physiological sodium chloride. The sodium hylauronate is extracted from rooster combs. It is given by intra-articular injection in a treatment cycle consisting of five injections given at weekly intervals. Some patients may experience benefit with three injections given at weekly cycles. This has been noted in studies reported in the literature in which patients treated with three injections were followed for 60 days.
FIDIA FARMACEUTICI SPA
89122-0724-20
Not in Commercial Distribution

  • M71389122072420A1 ()
89122-0724-20

  • Synovial fluid supplementation medium
Hyalgan® Sodium Hylauronate (20mg/2mL) in the 2mL vial is indicated for the treatment of pain in osteoarthritis (OA) of the knee in patients who have failed to respond adequately to conservative nonpharmacologic therapy and to simple analgesics, e.g., acetaminophen. It is a viscous solution of purified natural Sodium Hylauronate (Hyalectin®) in buffered physiological sodium chloride. The sodium hylauronate is extracted from rooster combs. It is given by intra-articular injection in a treatment cycle consisting of five injections given at weekly intervals. Some patients may experience benefit with three injections given at weekly cycles. This has been noted in studies reported in the literature in which patients treated with three injections were followed for 60 days.
FIDIA FARMACEUTICI SPA
89122-0724-12
In Commercial Distribution

89122-0724-12

  • Synovial fluid supplementation medium
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