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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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M.BLUE CHECKMATE
Aesculap AG
FX894T
In Commercial Distribution

  • 04041906505004 ()
FX894T

  • Cerebrospinal fluid shunt valve programmer
M.BLUE PLUS ADJUSTMENT ASSISTANT
Aesculap AG
FX893T
In Commercial Distribution

  • 04041906504991 ()
FX893T

  • Cerebrospinal fluid shunt valve programmer
M.BLUE PLUS ADJUSTMENT RING
Aesculap AG
FX892T
In Commercial Distribution

  • 04041906504984 ()
FX892T

  • Cerebrospinal fluid shunt valve programmer
M.BLUE PLUS COMPASS
Aesculap AG
FX891T
In Commercial Distribution

  • 04041906504977 ()
FX891T

  • Cerebrospinal fluid shunt valve programmer
M.BLUE PLUS INSTRUMENTS SET
Aesculap AG
FX890T
In Commercial Distribution

  • 04041906504960 ()
FX890T

  • Cerebrospinal fluid shunt valve programmer
PROGAV 2.0 TOOL SET EXTENDED
Christoph Miethke GmbH & Co. KG
FX499T
In Commercial Distribution

  • 04041906141714 ()
FX499T

  • Cerebrospinal fluid shunt valve programmer
PROGAV 2.0 ADJUSTMENT INSTRUMENT
Christoph Miethke GmbH & Co. KG
FX400T
In Commercial Distribution

  • 04041906140847 ()
FX400T

  • Cerebrospinal fluid shunt valve programmer
PROGAV 2.0 COMPASS
Christoph Miethke GmbH & Co. KG
FX401T
In Commercial Distribution

  • 04041906140830 ()
FX401T

  • Cerebrospinal fluid shunt valve programmer
BONE ULTRASONOMETER, ACHILLES
GE Medical Systems (China) Co.,Ltd.
v1
Not in Commercial Distribution

  • 00840682116978 ()


  • Bone absorptiometric ultrasound system
"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
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