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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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LOOKEE LED TENS Unit, StimPlus Patch, Transcutaneous electrical nerve stimulator for pain relief
Lookee Tech
PL-029K30
In Commercial Distribution

  • 10628176949212 ()
  • 00628176949215 ()


  • Analgesic transcutaneous electrical nerve stimulation system
InMode RF Pro system with the non-invasive applicators employs RF energy for various applications: • i-Forma, Forma (Plus), Plus (Plus Plus) and Plus90 for relief of minor muscle aches and pain, relief of muscle spasm, and temporary improvement of local blood circulation. • WMface is intended for use in dermatologic procedures for non-invasive treatment of mild to moderate facial wrinkles and rhytids. • BodyFX™ (WMBody)/MiniFX™ for Relief of minor muscle aches and pain, relief of muscle spasm, temporary improvement of local blood circulation and temporary reduction in the appearance of cellulite. The InMode RF Pro System with the Fractional Applicators employs RF energy for various applications: • Fractora Applicator with 60 pins tip is designed for use in dermatological procedures requiring ablation and resurfacing of the skin. • Fractora Applicator with 24 pins tip is intended for use in dermatological and general surgical procedures for electrocoagulation and hemostasis. At higher energy levels greater than 62mJ/pin, use of the applicator is limited to skin types I-IV • Morpheus8™ for dermatological and general surgical procedures for electrocoagulation and hemostasis. At higher energy levels greater than 62mJ/pin, use of the applicator is limited to skin types I-IV
INMODE M.D LTD
AG609933A
In Commercial Distribution

  • 07290016633702 ()
AG609933A

  • Multi-modality skin surface treatment system
i-Forma Applicator applies RF energy through bipolar electrodes. The applicator has 2 RF electrodes, handle, cable, connector, and temperature sensors.
INMODE M.D LTD
AG609417A
In Commercial Distribution

  • 07290016633658 ()


  • Radio-frequency skin surface treatment system applicator
The DEFINE System is designed to deliver non-thermal RF energy to the skin and subdermal fat. .
INMODE M.D LTD
AG612444A
In Commercial Distribution

  • 07290016633573 ()
AG612444A

  • Radio-frequency skin surface treatment/fat liquefaction system control unit
ApexRF handpiece is indicated for the temporary relief of minor muscle aches and pain, temporary relief of muscle spasms, and temporary improvement of local blood circulation.
INMODE M.D LTD
AG614409A
In Commercial Distribution

  • 07290019863359 ()
AG614409A

  • Percutaneous radio-frequency ablation system generator
Apex RF system employs radiofrequency (RF) energy and Electrical Muscle Stimulation (EMS) technology for various aesthetic and medical application.
INMODE M.D LTD
AG614329A
In Commercial Distribution

  • 07290019863342 ()
AG614329A

  • Percutaneous radio-frequency ablation system generator
The CelluTite System with the BodyFX and Plus Handpieces is a medical aesthetic device combining mechanical vacuum skin massaging and non-thermal RF energy for the treatment of selected medical conditions such as relief of minor muscle aches and pain, relief of muscle spasm, temporary improvement of local blood circulation, and temporary reduction in the appearance of cellulite. Morpheus8C employs bi-polar Radio-frequency (RF) technology for use in dermatologic and general surgical procedures for electrocoagulation and hemostasis for various aesthetic applications. The device provides individual adjustment of treatment parameters to achieve maximum efficiency and safety for each patient and applications.
INMODE M.D LTD
AG612700A
In Commercial Distribution

  • 07290019863014 ()
AG612700A

  • Multi-modality skin surface treatment system
ELMED TP-4 TELESCOPE PREHEATER FOR SIMULTANEOUSLY PREHEATING UP TO 4 OPTICS - 2MM TO 10MM DIA., ELECTRONICALLY CONTROLLED VARIABLE TEMPERATURE WITH DIGITAL READOUT...INCLUDES: 2EA NO.:52033-51 AND 52033-52, AUTOCLAVABLE SS REMOVABLE HEATING TUBES FOR 1...
ELMED INCORPORATED
52033-50
In Commercial Distribution

  • 00842180162372 ()
52033-50

  • Laparoscopic surgical procedure kit, non-medicated, reusable
Airlife™ Isothermal™ Breathing Circuit Adult Respiratory Circuit MR850
Carefusion Corporation
RT607-853
Not in Commercial Distribution

  • 50885403040007 ()
  • 10885403040009 ()
RT607-853

  • Non-heated respiratory humidifier
  • Ventilator breathing circuit, single-use
Airlife™ Isothermal™ Breathing Circuit Adult Respiratory Circuit Heated
Carefusion Corporation
9072-HS7
Not in Commercial Distribution

  • 50885403039902 ()
  • 10885403039904 ()
9072-HS7

  • Non-heated respiratory humidifier
  • Ventilator breathing circuit, single-use
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