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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Smooth Ultra High Profile Silicone Gel-Filled Breast Implant 930cc
MENTOR TEXAS L.P.
SUHE930
In Commercial Distribution

  • 10081317031106 ()
SUHE-930

  • Silicone gel-filled breast implant, smooth-surface
Smooth Ultra High Profile Silicone Gel-Filled Breast Implant 1445cc
MENTOR TEXAS L.P.
SUHE1445
In Commercial Distribution

  • 10081317031090 ()
SUHE-1445

  • Silicone gel-filled breast implant, smooth-surface
Smooth Ultra High Profile Silicone Gel-Filled Breast Implant 1340cc
MENTOR TEXAS L.P.
SUHE1340
In Commercial Distribution

  • 10081317031083 ()
SUHE-1340

  • Silicone gel-filled breast implant, smooth-surface
Smooth Ultra High Profile Silicone Gel-Filled Breast Implant 1240cc
MENTOR TEXAS L.P.
SUHE1240
In Commercial Distribution

  • 10081317031076 ()
SUHE-1240

  • Silicone gel-filled breast implant, smooth-surface
Smooth Ultra High Profile Silicone Gel-Filled Breast Implant 1135cc
MENTOR TEXAS L.P.
SUHE1135
In Commercial Distribution

  • 10081317031069 ()
SUHE-1135

  • Silicone gel-filled breast implant, smooth-surface
Smooth Ultra High Profile Silicone Gel-Filled Breast Implant 1030cc
MENTOR TEXAS L.P.
SUHE1030
In Commercial Distribution

  • 10081317031052 ()
SUHE-1030

  • Silicone gel-filled breast implant, smooth-surface
The PulStar Spine Mobilization Device is intended for use by chiropractors, physical therapists and physicians for mobilization of the spine. The device consists of a hand-held impulse head attached to an electronic control module. The control module is connected to an Apple computer through a USB cable. Appropriate software is used to display the results of tissue compliance measurements. Intended Use and operation: Intended use of the PulStar is for the treatment of musculoskeletal pain due to joint subluxation, restricted joint mobility, myofacial spasm and ligamentous strain. The clinician uses a hand held impulse head to test the stiffness of the patient’s spine at each vertebral level, the results of this procedure are recorded in the patient file in a computer database and displayed on the computer screen. The clinician then decides where therapy is needed and applies multiple impulses with the impulse head to those areas of the body of the patient with the intent of reducing spinal stiffness. After treatment, the clinician repeats the initial test of the patient’s spine to document changes in stiffness effected by the therapy.
Sense Technology, Inc.
G3
In Commercial Distribution

  • 10855341008003 ()
  • 00855341008006 ()


  • Joint/spinal manipulator, electronic
Chiropractic adjusting instrument; Hand-held medical manipulation/mobilization device for the intended use of manipulation/mobilization of musculoskeletal joints that provides impulsive single and multiple thrusts over manually selectable force settings.
Neuromechanical Innovations, L.L.C.
ProAdjuster Kidz
Not in Commercial Distribution

  • 00860011416494 ()


  • Joint/spinal manipulator, electronic
Chiropractic adjusting instrument; Hand-held medical manipulation/mobilization device for the intended use of manipulation/mobilization of musculoskeletal tissues that provides impulsive single and multiple thrusts over three selectable force settings.
Neuromechanical Innovations, L.L.C.
Prosoft SRT
In Commercial Distribution

  • 00860011416487 ()


  • Joint/spinal manipulator, electronic
Chiropractic adjusting instrument; Hand-held medical manipulation/mobilization device for the intended use of manipulation/mobilization of musculoskeletal joints that provides impulsive single and multiple thrusts over three selectable force settings.
Neuromechanical Innovations, L.L.C.
ProAdjuster SRT
In Commercial Distribution

  • 00860011416470 ()


  • Joint/spinal manipulator, electronic
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