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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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ENCOR® Breast Biopsy System Driver
SENORX, INC.
DRENCOR
In Commercial Distribution

  • 00801741086076 ()
DRENCOR

  • Mammographic stereotactic biopsy system
ENCOR® Breast Biopsy System Control Module
SENORX, INC.
CM3000
Not in Commercial Distribution

  • 00801741086052 ()
CM3000

  • Mammographic stereotactic biopsy system
ENCOR ENSPIRE® Breast Biopsy System Driver Holder
SENORX, INC.
AC4001
In Commercial Distribution

  • 00801741085956 ()
AC4001

  • Mammographic stereotactic biopsy system
VACORA® Vacuum Assisted Biopsy System, Adapter Siemens™ Stereotactic Systems
Bard Peripheral Vascular, Inc.
VA1SI
Not in Commercial Distribution

  • 00801741079719 ()
VA1SI

  • Mammographic stereotactic biopsy system
VACORA® Vacuum Assisted Biopsy System, Adapter Plate Siemens™ MRI Systems
Bard Peripheral Vascular, Inc.
VA1MRSI
Not in Commercial Distribution

  • 00801741079702 ()
VA1MRSI

  • Mammographic stereotactic biopsy system
VACORA® Vacuum Assisted Biopsy System, Adapter Plate Siemens™ MammoTest™ Stereotactic Table
Bard Peripheral Vascular, Inc.
VA1MA
Not in Commercial Distribution

  • 00801741079696 ()
VA1MA

  • Mammographic stereotactic biopsy system
VACORA® Vacuum Assisted Biopsy System, Adapter Plate Lorad™ Stereotactic Table
Bard Peripheral Vascular, Inc.
VA1LO
Not in Commercial Distribution

  • 00801741079689 ()
VA1LO

  • Mammographic stereotactic biopsy system
VACORA® Vacuum Assisted Biopsy System
Bard Peripheral Vascular, Inc.
VF2019
Not in Commercial Distribution

  • 00801741079672 ()
VF2019

  • Mammographic stereotactic biopsy system
VACORA® Vacuum Assisted Biopsy System, Distance Ring 14G x 10 mm
Bard Peripheral Vascular, Inc.
VBD1410
Not in Commercial Distribution

  • 10801741079549 ()
  • 00801741079542 ()

  • 14 Gauge
  • Length: 10 Millimeter
VBD1410

  • Mammographic stereotactic biopsy system
VACORA® Vacuum Assisted Biopsy System, Distance Ring 10G x 10 mm
Bard Peripheral Vascular, Inc.
VBD1010
Not in Commercial Distribution

  • 10801741079532 ()
  • 00801741079535 ()

  • Length: 10 Millimeter
  • 10 Gauge
VBD1010

  • Mammographic stereotactic biopsy system
Audyx is an online audiology platform for patients care. It runs on a computing device connected to the Internet as well as to an electro-acoustic system to produce controlled signals to perform audiometric evaluation and to assist in the diagnosis of otological disorders
KOALYS TECHNOLOGIES LTD
2.X
In Commercial Distribution

  • 07290017820019 ()
N/A

  • Tone audiometer
No Description
Nordicneurolab AS
ETC 2.0
In Commercial Distribution

  • 07090042052023 ()


  • Eye movement analysis system
NeoNavia base unit
NeoDynamics AB (publ)
1102
Not in Commercial Distribution

  • 27350081940083 ()
  • 17350081940086 ()
1102

  • Mammographic stereotactic biopsy system
NeoNavia driver
NeoDynamics AB (publ)
1103
Not in Commercial Distribution

  • 27350081940045 ()
  • 17350081940048 ()
  • 37350081940042 ()
1103

  • Mammographic stereotactic biopsy system
Intra Oral Camera
Guangdong JINME Medical Technology Co., Ltd.
ECO-CAMERA 03
In Commercial Distribution

  • 06971119542382 ()


  • Intraoral camera
Intra Oral Camera
Guangdong JINME Medical Technology Co., Ltd.
ECO-CAMERA 02
In Commercial Distribution

  • 06971119540975 ()


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

  • 06971119540968 ()


  • Intraoral camera
Affirm® breast biopsy guidance system software is designed to allow the accurate location of lesions in the breast in three dimensions. It is intended to provide guidance for interventional purposes such as biopsy, pre-surgerical localization or treatment devices.
Hologic, Inc.
AFFIRM™ CONTRAST BIOPSY SOFTWARE
In Commercial Distribution

  • 15420045512948 ()
CMP-01771

  • Mammographic stereotactic biopsy system
No Description
Hologic, Inc.
AFFIRM™ SPECIMEN IMAGING
In Commercial Distribution

  • 15420045512931 ()


  • Mammographic stereotactic biopsy system
Single-use, disposable needle for acquiring biopsy specimens.
Hologic, Inc.
BREVDISP09
In Commercial Distribution

  • 15420045512863 ()
  • 15420045512870 ()
BREVDISP09

  • Mammographic stereotactic biopsy system
No Description
Hologic, Inc.
PBX-SYS-AFFIRM-2D
In Commercial Distribution

  • 15420045510845 ()
PBX-SYS-AFFIRM-2D

  • Mammographic stereotactic biopsy system
PRODUCT, HANDPIECE, CALIBRATE, 13CM, EVIVA
Hologic, Inc.
EVIVA_CALIBRATE_13CM
In Commercial Distribution

  • 15420045509962 ()
  • 25420045509969 ()
EVIVA_CALIBRATE_13CM

  • Mammographic stereotactic biopsy system
PRODUCT, BUSHING, GE, EVIVA
Hologic, Inc.
EVIVA_BUSHING_GE
In Commercial Distribution

  • 15420045509948 ()
  • 25420045509945 ()
EVIVA_BUSHING_GE

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

  • 15420045509931 ()


  • Mammographic stereotactic biopsy system
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
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