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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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Intra Oral Camera
Guangdong JINME Medical Technology Co., Ltd.
ECO-CAMERA 01
In Commercial Distribution

  • 06971119540968 ()


  • Intraoral camera
No Description
Hologic, Inc.
EVIVA_STX_KIT_INSPIR
In Commercial Distribution

  • 15420045509924 ()


  • Mammographic stereotactic biopsy system
No Description
Hologic, Inc.
Eviva_STX_Kit_Opdima
In Commercial Distribution

  • 15420045509917 ()


  • Mammographic stereotactic biopsy system
No Description
Hologic, Inc.
Eviva_STX_Kit_Affirm
In Commercial Distribution

  • 15420045509900 ()


  • Mammographic stereotactic biopsy system
No Description
Hologic, Inc.
Eviva_STX_KIT_GEL-V
In Commercial Distribution

  • 15420045509894 ()


  • Mammographic stereotactic biopsy system
No Description
Hologic, Inc.
Eviva_STX_KIT_GEVER
In Commercial Distribution

  • 15420045509887 ()


  • Mammographic stereotactic biopsy system
No Description
Hologic, Inc.
Eviva_STX_KIT_GELAT
In Commercial Distribution

  • 15420045509870 ()


  • Mammographic stereotactic biopsy system
No Description
Hologic, Inc.
Eviva_STX_KIT_SLOC
In Commercial Distribution

  • 15420045509863 ()


  • Mammographic stereotactic biopsy system
No Description
Hologic, Inc.
Eviva_STX_KIT_MTEST
In Commercial Distribution

  • 15420045509856 ()


  • Mammographic stereotactic biopsy system
No Description
Hologic, Inc.
ATEC STXFISCHER
In Commercial Distribution

  • 15420045509849 ()


  • Mammographic stereotactic biopsy system
No Description
Hologic, Inc.
ATEC STX-2
In Commercial Distribution

  • 15420045509832 ()


  • Mammographic stereotactic biopsy system
No Description
Hologic, Inc.
ATEC STX-1
In Commercial Distribution

  • 15420045509825 ()


  • Mammographic stereotactic biopsy system
No Description
Hologic, Inc.
SR3000-04
In Commercial Distribution

  • 15420045509818 ()


  • Mammographic stereotactic biopsy system
A biopsy device adapter used to hold the biopsy device in place on a compatible biopsy system.
Hologic, Inc.
BREVADPTRM
In Commercial Distribution

  • 15420045507838 ()
  • 25420045507835 ()
BREVADPTRM

  • Mammographic stereotactic biopsy system
A biopsy device adapter used to hold the biopsy device in place on a compatible biopsy system.
Hologic, Inc.
BREVADPTR
In Commercial Distribution

  • 15420045507807 ()
  • 25420045507804 ()
BREVADPTR

  • Mammographic stereotactic biopsy system
The reusable device driver is the electromechanical component of the Brevera(R) (R) Breast Biopsy system.
Hologic, Inc.
BREVDRV
In Commercial Distribution

  • 15420045507760 ()
  • 25420045507767 ()
BREVDRV

  • Mammographic stereotactic biopsy system
Vacuum-assisted biopsy device used to remove breast tissue in a minimally invasive manner using stereotactic or tomosyntheses imaging.
Hologic, Inc.
BREV200
In Commercial Distribution

  • 15420045507753 ()
BREV200

  • Mammographic stereotactic biopsy system
Vacuum-assisted biopsy device used to remove breast tissue in a minimally invasive manner using stereotactic or tomosyntheses imaging.
Hologic, Inc.
BREV100
In Commercial Distribution

  • 15420045507517 ()
  • 25420045507514 ()
BREV100

  • Mammographic stereotactic biopsy system
Affirm Prone Biopsy Complete Gantry
Hologic, Inc.
ASY-09175
In Commercial Distribution

  • 15420045506541 ()
ASY-09175

  • Mammographic stereotactic biopsy system
AFFIRM PRONE BIOPSY ACQUISITION WORKSTATION
Hologic, Inc.
ASY-08832
In Commercial Distribution

  • 15420045506534 ()
ASY-08832

  • Mammographic stereotactic biopsy system
AFFIRM PRONE BIOPSY SYSTEM, 3D
Hologic, Inc.
PBX-SYS-AFFIRM-3D
In Commercial Distribution

  • 15420045506510 ()
PBX-SYS-AFFIRM-3D

  • Mammographic stereotactic biopsy system
PADDLE, BIOPSY, STANDARD, 6 CM X 7 CM
Hologic, Inc.
ASY-08176
In Commercial Distribution

  • 15420045506480 ()
  • 25420045506487 ()
ASY-08176

  • Mammographic stereotactic biopsy system
PADDLE, BIOPSY, STANDARD, 5 CM X 5 CM
Hologic, Inc.
ASY-08175
In Commercial Distribution

  • 15420045506473 ()
  • 25420045506470 ()
ASY-08175

  • Mammographic stereotactic biopsy system
PADDLE, BIOPSY, AXILLA, 5 CM X 5 CM
Hologic, Inc.
ASY-08174
In Commercial Distribution

  • 15420045506466 ()
  • 25420045506463 ()
ASY-08174

  • Mammographic stereotactic biopsy system
No Description
Hologic, Inc.
8-004-0017
Not in Commercial Distribution

  • 15420045505926 ()
8-004-0017

  • Mammographic stereotactic biopsy system
AFFIRM SYSTEM, S/W 3D LICENSE
Hologic, Inc.
3D System Software
In Commercial Distribution

  • 15420045504738 ()
SW-04300

  • Mammographic stereotactic biopsy system
No Description
Hologic, Inc.
System Software
In Commercial Distribution

  • 15420045504721 ()


  • Mammographic stereotactic biopsy system
ALL-IN-ONE BREAST BIOPSY SYSTEM FOR BIOPSIES UNDER STEREOTACTIC, ULTRASOUND OR MRI GUIDANCE
Hologic, Inc.
ATEC SAPPHIRE
In Commercial Distribution

  • 15420045504295 ()
ATEC SAPPHIRE

  • Mammographic stereotactic biopsy system
220V-50HZ ALL IN ONE BREAST BIOPSY SYSTEMS FOR BIOPS UNDER STEREOTATIC, ULTRASOND OR MRI GUIDNCE
Hologic, Inc.
ATEC SAPPHIRE25
In Commercial Distribution

  • 15420045504288 ()
ATEC SAPPHIRE25

  • Mammographic stereotactic biopsy system
200 ALL IN ONE BREAST BIOPSY SYSTEM FOR BIOPSIES UNDER STEREOTACTIC, ULTRASOUND OR MRI GUIDANCE
Hologic, Inc.
ATEC Sapphire 200
In Commercial Distribution

  • 15420045504110 ()
ATEC SAPPHIRE 200

  • Mammographic stereotactic biopsy system
100 ALL-IN-ONE BREAST BIOPSY SYSTEM FOR BIOPSIES UNDER STEREOTACTIC, ULTRASOUND OR MRI GUIDANCE
Hologic, Inc.
ATEC SAPPHIRE 100
In Commercial Distribution

  • 15420045504028 ()
ATEC SAPPHIRE 100

  • Mammographic stereotactic biopsy system
Biopsy Digit device uses two stereo images taken by a digital solid state camera to determine the location of a lesion in three dimensions. It is intended to mammographic procedures requiring stereotactic guidance, such as fine needle aspiration, needle biopsy and guide wire placement.
I.M.S. INTERNAZIONALE MEDICO SCIENTIFICA SRL
BIOPSY DIGIT AM
In Commercial Distribution

  • 18033837190216 ()
  • 08033837190219 ()

  • Height: 347 Millimeter
  • Depth: 303 Millimeter
  • Width: 350 Millimeter
9100-01

  • Mammographic stereotactic biopsy system
A battery operated moving cart holding a processing unit/computer (PC) that drives the handheld scanner, power supplies and a display
3shape Trios A/S
TRIOS 3 battery cart
Not in Commercial Distribution

  • 05902768365511 ()


  • Dental milling system, CAD/CAM, chairside
The Cassette 18cmx24cm(IP 18cmx24cm)Kit is acquired X-ray images. and Transfer the image to your computer through the FireCR Flash.
Digiray Corp.
CA06
In Commercial Distribution

  • 08809466040443 ()

  • Width: 18 Centimeter
  • Length: 24 Centimeter
  • Weight: 0.6 Kilogram


  • X-ray film cassette, manual
The Cassette 24cmx30cm(IP 24cmx30cm)Kit is acquired X-ray images. and Transfer the image to your computer through the FireCR Flash.
Digiray Corp.
CA05
In Commercial Distribution

  • 08809466040436 ()

  • Weight: 1.1 Kilogram
  • Length: 30 Centimeter
  • Width: 24 Centimeter


  • X-ray film cassette, manual
The Cassette 35cmx43cm(IP 35cmx43cm)Kit is acquired X-ray images. and Transfer the image to your computer through the FireCR Flash.
Digiray Corp.
CA04
In Commercial Distribution

  • 08809466040429 ()

  • Width: 35 Centimeter
  • Length: 43 Centimeter
  • Weight: 1.9 Kilogram


  • X-ray film cassette, manual
The Universal Cassette 24cmx30cm(IP 24cmx30cm)Kit is acquired X-ray images. and Transfer the image to your computer through the FireCR.
Digiray Corp.
CA02
In Commercial Distribution

  • 08809466040030 ()

  • Width: 30 Centimeter
  • Length: 24 Centimeter
  • Weight: 1.5 Kilogram


  • X-ray film cassette, manual
The Universal Cassette 35cmx43cm(IP 35cmx43cm)Kit is acquired X-ray images. and Transfer the image to your computer through the FireCR.
Digiray Corp.
CA01
In Commercial Distribution

  • 08809466040023 ()

  • Width: 35 Centimeter
  • Length: 43 Centimeter
  • Weight: 1.9 Kilogram


  • X-ray film cassette, manual
MAW is a Management & Acquisition Workstation with 21" LCD 2Mpixel monitor, dedicated computer for images acquisition/processing. DVD/CD professional burner.
I.M.S. INTERNAZIONALE MEDICO SCIENTIFICA SRL
MAW
In Commercial Distribution

  • 08033837190035 ()
  • 18033837190032 ()

  • Height: 1920 Millimeter
  • Depth: 470 Millimeter
  • Width: 1175 Millimeter
6006-15GM3

  • Radiology DICOM image processing application software
The VITEK® MS Software is a computer application which supports the microbiology laboratory workflow for the VITEK® MS Systems.
BIOMERIEUX SA
VITEK MS SW V1.1
In Commercial Distribution

  • 03573026621698 ()


  • Microbial identification mass spectrometry system IVD
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