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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 FlexLab X automation is a modular system designed to automate Pre-Analytical and Post-Analytical processing, sample handling in order to automate sample processing in the Laboratory. The system consolidates multiple Analytical instruments into a unified workstation.
Inpeco SA
FXX
In Commercial Distribution

  • 07640172344002 ()


  • Specimen processing instrument IVD
Ultrasound Doppler Device (Doppler-Box X1)
Compumedics Germany GmbH
DBX1
In Commercial Distribution

  • 04260493310765 ()
7780

  • Invasive vascular ultrasound system
  • Noninvasive vascular ultrasound system, line-powered
Ultrasound Doppler Device
Compumedics Germany GmbH
DBX
In Commercial Distribution

  • 04260493310055 ()
7750

  • Noninvasive vascular ultrasound system, line-powered
  • Invasive vascular ultrasound system
MAIN ASSY, X SERIES MONITOR/DEFIBRILLATOR 12 LEAD/W INTERP, PACING, VOICE, NIBP, SPO2, SPCO, SPMET, IBP/TEMP CPR EXPANSION PACK AND ETCO2, FREN JAPANESE
Zoll Medical Corporation
610-2441511-36
In Commercial Distribution

  • 04560233593534 ()

  • 8.9" x 10.4" x 8.75"


  • Physiologic-monitoring defibrillation system
Defibrillator ,MAIN ASSY, X SERIES MONITOR/DEFIBRILLATOR 3/5 LEAD, NIBP, NIBP-MOD-G, SPO2, CPR EXPANSION PACK AND ETCO2, JAPAN
Zoll Medical Corporation
610-0121001-36
In Commercial Distribution

  • 04560233592995 ()

  • 8.9" x 10.4" x 8.75"


  • Rechargeable professional automated external defibrillator
Over the Counter Blue LED device for the treatment of acne.
Omm Imports Inc.
SX100
In Commercial Distribution

  • 00850001456203 ()


  • Blue-light phototherapy lamp, home-use
Over the counter red/IR device for the treatment of wrinkles.
Omm Imports Inc.
PX100
In Commercial Distribution

  • 00850001456036 ()


  • Blue/red/infrared phototherapy lamp
The PlasmaFlow X is intended to be an easy to use sequential compression system, prescribed by a physician, for use in the home or clinical setting to help prevent the onset of DVT in patients by stimulating blood flow in the extremities (stimulating muscle contractions). This device can be used to: Aid in the prevention of DVT Enhance blood circulation Diminish post-operative pain and swelling Reduce wound healing time Aid in the treatment and healing of: stasis dermatitis, venous stasis ulcers, arterial and diabetic leg ulcers, chronic venous insufficiency and reduction of edema in the lower limbs.
Manamed, Inc.
XPF0001
In Commercial Distribution

  • 00850998008478 ()
XPF0001

  • Intermittent venous compression system
Constriction Ring
AUGUSTA MEDICAL SYSTEMS, L.L.C.
Constriction Ring
In Commercial Distribution

  • 00852598007219 ()


  • Penile vacuum device
No Description
AXELGAARD MANUFACTURING CO., LTD.
USX2040-4
Not in Commercial Distribution

  • 00856817005871 ()


  • Transcutaneous electrical stimulation electrode, single-use
  • Transcutaneous electrical stimulation electrode, reusable
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