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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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Paragon Mobile with 14 x 17 Wireless Panel
MERIDIAN MEDICAL SYSTEMS, LLC
RT312
Not in Commercial Distribution

  • 00851354007159 ()


  • Mobile basic diagnostic x-ray system, digital
The ManaFlexx 2 delivers electric pulse generated to the user’s body areas through the electrodes. The device has two program modes of different pulse frequencies, covering TENS and PMS/NMES. For Prescription Use: TENS: ManaFlexx2 (MF002-RX) is intended for the following use:- Symptomatic relief and management of chronic, intractable pain- Adjunctive treatment for post-surgical and post-trauma acute pain- Relief of pain associated with arthritis PMS/NMES: ManaFlexx2 (MF002-RX) is intended for the following use:- Temporary relaxation of muscle spasm- Prevention or retardation of disuse atrophy- Muscle re-education- Maintaining or increasing range of motion- Increase of local blood flow in the treatment area- Prevention of post-surgical venous thrombosis through immediate stimulation of calf muscle
Manamed, Inc.
MF002-RX
In Commercial Distribution

  • 00850998008089 ()
MF002-RX

  • Physical therapy transcutaneous neuromuscular electrical stimulation system
Dreem 2 is a wireless sleep monitoring system consisting of a wearable headband that contains sensors to monitor sleep and a mobile application. Dreem 2 is intended to aid in relaxing and falling asleep and to generate reports, advices and contents to help the user better understand his or her sleep, and take steps to improve it.
DREEM
EFM00MD
Not in Commercial Distribution

  • 00850010086019 ()


  • Psychophysiological biofeedback system
The Visica 2 Treatment System is a cryosurgical system consisting of a control unit that controls one single use disposable probe. The system utilizes a cryogen, liquid nitrogen, as a cooling agent and a resistance heater for thawing. The Visica 2 Console is a self contained, mobile unit featuring an easy to use touch screen interface for complete control and monitoring of the cryoablation procedure. The touch screen allow users to select treatment modes, times, and cycles.
SANARUS TECHNOLOGIES, INC.
VS3000
In Commercial Distribution

  • 00868390000211 ()
VS3000

  • General cryosurgical system, cryogen gas, electronic
Portable Halogen Headlight
QED, INC.
QED-9500
In Commercial Distribution

  • 00860013851552 ()


  • Head-worn lamp
KneeAlign 2 Instrument Kit
Orthalign, Inc.
402064-09
In Commercial Distribution

  • 00858704006800 ()
402064-09

  • Orthopaedic surgical procedure kit, non-medicated, reusable
Button Cap, Black
Orthalign, Inc.
402047-03
In Commercial Distribution

  • 00858704006510 ()
402047-03

  • Orthopaedic surgical procedure kit, non-medicated, reusable
Button Cap, White
Orthalign, Inc.
402046-08
In Commercial Distribution

  • 00858704006503 ()
402046-08

  • Orthopaedic surgical procedure kit, non-medicated, reusable
Femoral Drill Guide, Neutral
Orthalign, Inc.
402418
In Commercial Distribution

  • 00858704006480 ()
402418

  • Orthopaedic surgical procedure kit, non-medicated, reusable
Threaded Pin, Headless, 65mm
Orthalign, Inc.
402069
In Commercial Distribution

  • 00858704006459 ()
  • 00851977007161 ()
402069

  • Orthopaedic surgical procedure kit, non-medicated, reusable
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