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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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No Description
RAUMEDIC AG
092627-001
In Commercial Distribution

  • 04057834025804 ()


  • Intracranial/compartmental-pressure monitor calibrator/cable
The SecondLook Computer-Aided Detection (CAD) system for mammography is intended to identify and mark regions of interest on screening and diagnostic mammograms from full-field digital mammography (FFDM) systems to bring them to the attention of the radiologist after an initial reading has been completed. Thus the system prompts the radiologist to areas on mammograms for second review only.
Icad, Inc.
V7.2
In Commercial Distribution

  • 00858012005038 ()
DSC010-03-US

  • Basic diagnostic x-ray system application software
No Description
Aktina Corp.
11-462
In Commercial Distribution

  • B365114620 ()


  • Radiological whole-body positioner
No Description
Philips Ds North America LLC
989803154031
Not in Commercial Distribution

  • 10884838054292 ()
989803154031

  • Pneumograph
Reusable non-sterile tracking bracket with (14 × 91.5cm) CIV-Flex™ covers (5) and cleaning brushes (5) for use with Siemens 9L4 transducers
CIVCO MEDICAL INSTRUMENTS CO., INC.
11292181
In Commercial Distribution

  • 00841436110709 ()
  • 20841436116804 ()

  • Length: 3.1 Inch
  • Width: 1.8 Inch
11292181

  • Ultrasound imaging system tracking positioner, reusable
Reusable non-sterile tracking bracket with cleaning brushes (5) for use with Siemens MC9-4 transducers
CIVCO MEDICAL INSTRUMENTS CO., INC.
676-196
In Commercial Distribution

  • 00841436110648 ()
  • 20841436117399 ()

  • Width: 1.9 Inch
  • Length: 2.1 Inch
676-196

  • Electromagnetic surgical navigation device tracking system
No Description
AB MEDICA GROUP, S.A.
1021602
In Commercial Distribution

  • 08428763005810 ()


  • Electrocardiographic recording paper
short-term patient stabilization
iSYS Medizintechnik GmbH
Thorax Kit MRI Siemens
In Commercial Distribution

  • 09010279001203 ()
58792

  • Limb/torso/head restraint, single-use
  • Medical table restraint anchor
short-term patient stabilization
iSYS Medizintechnik GmbH
Thorax Kit CT Siemens
In Commercial Distribution

  • 09010279001166 ()
58788

  • Limb/torso/head restraint, single-use
  • Medical table restraint anchor
No Description
ZURICH MEDICAL INC.
Siemens 8-Pin, Type I
In Commercial Distribution

  • 00850022994296 ()
512-144

  • Electrical-only medical device connection cable, reusable
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