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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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Repositionable system for localization of non palpable breast lesions 20G x 60mm O Type
MEDAX SRL UNIPERSONALE
XW20060-0O
In Commercial Distribution

  • 18052286425854 ()
  • 08052286425857 ()


  • Imaging lesion localization marker, external, single-use
No Description
WESTERN SYSTEMS RESEARCH INC.
MT07
In Commercial Distribution

  • B435MT07 ()


  • Posturography system
The device is a sterile or sterilizable (via PVP-I or similar antiseptic) accessory intended to mark a set of locations on a patient's intact, uncompromised skin. The device is also intended to mark objects in the operational field of view. The device is intended to be used in clinical settings, by clinicians familiar with aseptic technique.
CLEAR GUIDE MEDICAL, INC.
CGVMNS
In Commercial Distribution

  • B201CGVMNS0 ()
  • B201CGVMNS1 ()
  • B201CGVMNS3 ()
  • B201CGVMNS2 ()
CG-VM-NS

  • Imaging lesion localization marker, external, single-use
The device is a sterile or sterilizable (via PVP-I or similar antiseptic) accessory intended to mark a set of locations on a patient's intact, uncompromised skin. The device is also intended to mark objects in the operational field of view. The device is intended to be used in clinical settings, by clinicians familiar with aseptic technique.
CLEAR GUIDE MEDICAL, INC.
CGVM2NS
In Commercial Distribution

  • B201CGVM2NS0 ()
  • B201CGVM2NS1 ()
  • B201CGVM2NS3 ()
  • B201CGVM2NS2 ()
CG-VM2-NS

  • Imaging lesion localization marker, external, single-use
The device is a sterile or sterilizable (via PVP-I or similar antiseptic) accessory intended to mark a set of locations on a patient's intact, uncompromised skin. The device is also intended to mark objects in the operational field of view. The device is intended to be used in clinical settings, by clinicians familiar with aseptic technique.
CLEAR GUIDE MEDICAL, INC.
CGVM2
In Commercial Distribution

  • B201CGVM20 ()
  • B201CGVM21 ()
  • B201CGVM23 ()
  • B201CGVM22 ()
CG-VM2

  • Imaging lesion localization marker, external, single-use
The device is a sterile or sterilizable (via PVP-I or similar antiseptic) accessory intended to mark a set of locations on a patient's intact, uncompromised skin. The device is also intended to mark objects in the operational field of view. The device is intended to be used in clinical settings, by clinicians familiar with aseptic technique.
CLEAR GUIDE MEDICAL, INC.
CGVM
In Commercial Distribution

  • B201CGVM2 ()
  • B201CGVM1 ()
  • B201CGVM0 ()
  • B201CGVM3 ()


  • Imaging lesion localization marker, external, single-use
"Tetrax balance assessment is used to quantitatively detect changes in postural responses that have been shown to be indicative of the presence of a disturbance or pathology that affects balance and posture. It is used for the assessment of fall risk and as an aid in the diagnosis of a number of conditions that affect balance. The device designed in tour different modifications: Tetrax system contains platform and railing and Tetrax Free Plates that includes only 2 balance plates. The Tetrax provides valuable information concerning the functioning of neuro-physiological centers of postural control. This information assists the physician in confirming clinical impressions or suspicions. It helps to focus tests prescribed for the patient, and, more important, limits unnecessary tests, especially in cases of dizziness, vertigo, tiredness, and many other balance disorders or pathologies. The Tetrax system offers the possibility of evaluating the effects of therapeutic interventions in such cases. The system is capable of providing the physician with a comprehensive assessment of postural control and therefore may be used to assess accident proneness due to fatigue, stress, and/or intoxication. The Tetrax system provides valuable information on the effectiveness of prosthetic devices, including prostheses, splints, corsets, etc. Tetrax has wide application in the field of child psychology and developmental pediatrics and can be used in children for detecting neuro-physiological sources of insufficient school readiness, learning disabilities, dyslexia, Attention Deficit Disorders (ADD), etc. The Tetrax device includes a balance platform with a USB connector and software supplied on a CD for installation on a standard PC or an Omnisense device. The Tetrax balance platform is a platform that includes four separate plates. The subject stands on the platform, with each heel and toe-part on one of the four plates, guided by a foot-shaped sketch on each of the plates. Within
BEAMMED LTD
PLATFORM FORCE-MEASURING
Not in Commercial Distribution

  • 72990012704126 ()


  • Bone absorptiometric ultrasound system
No Description
Izi Medical Products, LLC
G04303
In Commercial Distribution

  • 00815212024306 ()


  • Imaging lesion localization marker, external, single-use
No Description
Izi Medical Products, LLC
G20782
In Commercial Distribution

  • 00815212024290 ()


  • Imaging lesion localization marker, external, single-use
No Description
Izi Medical Products, LLC
G19533
In Commercial Distribution

  • 00815212024283 ()


  • Imaging lesion localization marker, external, single-use
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