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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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The EXOGEN Ultrasound Bone Healing System provides non-invasive therapy for healing non-unions and accelerating time to healing of fresh fractures. EXOGEN is designed both for use with conservatively treated fresh fractures and non-unions, or surgically-treated non-unions. EXOGEN 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. 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. EXOGEN automatically alerts the patient in case of improper application or performance. The EXOGEN Ultrasound Bone Healing System consists of one EXOGEN device, a charger, a gel bottle and strap. The EXOGEN device provides the treatment control circuitry, the battery supply and monitors the operation of the transducer at the fracture site. Thesignal specifications cannot be changed.
BIOVENTUS LLC
71034400
In Commercial Distribution

  • M937710344001 ()
71034400

  • Bone growth ultrasonic stimulator
  • Radiographic image marker, manual
  • Skin topical coupling gel
  • Personal device holder, single-use
  • Noninvasive device battery charger
This Biofeedback Nerve and Muscle Stimulator is a new type of biofeedback and neuromuscular electrical stimulation therapy device through the evaluation of myoelectric signal acquisition, multimedia biofeedback training, electromyography triggered electrical stimulation, passive electrical stimulation training and treatment.
Shenzhen Konmed Technology Co., Ltd.
KM531
In Commercial Distribution

  • 06970935830543 ()


  • Pelvic floor exercise biofeedback device
This Biofeedback Nerve and Muscle Stimulator is a new type of biofeedback and neuromuscular electrical stimulation therapy device through the evaluation of myoelectric signal acquisition, multimedia biofeedback training, electromyography triggered electrical stimulation, passive electrical stimulation training and treatment.
Shenzhen Konmed Technology Co., Ltd.
KM530
In Commercial Distribution

  • 06970935830536 ()


  • Pelvic floor exercise biofeedback device
The Restech Dx–pH Measurement System is intended for gastroesophageal pH measurement and monitoring of gastric reflux. The pH data Recorder and data viewing program are intended for gastroesophageal pH data acquisition and analysis to diagnose reflux disorders.
Respiratory Technology Corporation
Dx-1000
In Commercial Distribution

  • 00899994002103 ()


  • Gastric pH ambulatory recorder
RScribe 12-Lead Multi-Channel Electrocardiograph - version 6, current software CD; AM12 Wired Acquisition Module; Adult and pediatric interpretation; Software kit; US/Canada power cord; No printer; No accessories; IEC 10 wire, 12-lead lead set with banana plugs; No connectivity
WELCH ALLYN, INC.
901127
In Commercial Distribution

  • 00732094312829 ()
RSCRIBE-6CC-AXDBX

  • Electrocardiograph, professional, multichannel
The ExamVue DR software is designed for use by radiologists and radiology technicians for the acquisition of digital x-ray images. It interfaces with 3rd party digital x-ray detectors or CR scanners and manufacturer supplied software for the acquisition and storage of digital x-ray images. The ExamVue DR software then provides a user interface for the viewing, annotating, and other workstation functions. ExamVue DR includes the ability to receive patient information and send x-ray images to remote destinations using the DICOM 3.0 protocol.
JPI HEALTHCARE. CO., LTD.
ExamVue DR
In Commercial Distribution

  • 08809413810488 ()


  • Basic diagnostic x-ray system application software
The ExamVue DR software is designed for use by radiologists and radiology technicians for the acquisition of digital x-ray images. It interfaces with 3rd party digital x-ray detectors or CR scanners and manufacturer supplied software for the acquisition and storage of digital x-ray images. The ExamVue DR software then provides a user interface for the viewing, annotating, and other workstation functions. ExamVue DR includes the ability to receive patient information and send x-ray images to remote destinations using the DICOM 3.0 protocol.
JPI HEALTHCARE. CO., LTD.
ExamVue DR
In Commercial Distribution

  • 08809413810143 ()


  • Basic diagnostic x-ray system application software
WALG WOVEN KNEE SLEEVE WITH SIDE STABILIZERS MD
WALGREEN CO.
985363
In Commercial Distribution

  • 10049022963426 ()
  • 00049022963429 ()


  • Tubular support bandage, non-latex, reusable
WALG ANKLE SUPPORT ADJ OS
WALGREEN CO.
985247
In Commercial Distribution

  • 10049022963396 ()
  • 00049022963399 ()


  • Ankle binder, reusable
WALG ELBOW SUPPORT WITH PAD L/XL
WALGREEN CO.
985246
In Commercial Distribution

  • 10049022963389 ()
  • 00049022963382 ()


  • Tubular support bandage, non-latex, reusable
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