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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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Audyx - 07290017820019

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

Eye Tracker Camera - 07090042052023

No Description
Nordicneurolab AS
ETC 2.0
In Commercial Distribution

  • 07090042052023 ()


  • Eye movement analysis system

NeoNavia Biopsy System - 17350081940086

NeoNavia base unit
NeoDynamics AB (publ)
1102
Not in Commercial Distribution

  • 27350081940083 ()
  • 17350081940086 ()
1102

  • Mammographic stereotactic biopsy system

NeoNavia Biopsy System - 17350081940048

NeoNavia driver
NeoDynamics AB (publ)
1103
Not in Commercial Distribution

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

  • Mammographic stereotactic biopsy system

Intra Oral Camera - 06971119542382

Intra Oral Camera
Guangdong JINME Medical Technology Co., Ltd.
ECO-CAMERA 03
In Commercial Distribution

  • 06971119542382 ()


  • Intraoral camera

Intra Oral Camera - 06971119540975

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

  • 06971119540975 ()


  • Intraoral camera

Intra Oral Camera - 06971119540968

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

  • 06971119540968 ()


  • Intraoral camera

AFFIRM™ CONTRAST BIOPSY - 15420045512948

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

AFFIRM™ SPECIMEN IMAGING - 15420045512931

No Description
Hologic, Inc.
AFFIRM™ SPECIMEN IMAGING
In Commercial Distribution

  • 15420045512931 ()


  • Mammographic stereotactic biopsy system

Brevera Breast Biopsy System - 15420045512863

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

  • 15420045512863 ()
  • 15420045512870 ()
BREVDISP09

  • Mammographic stereotactic biopsy system

Affirm Prone Biopsy System - 15420045510845

No Description
Hologic, Inc.
PBX-SYS-AFFIRM-2D
In Commercial Distribution

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

  • Mammographic stereotactic biopsy system

Eviva - 15420045509962

PRODUCT, HANDPIECE, CALIBRATE, 13CM, EVIVA
Hologic, Inc.
EVIVA_CALIBRATE_13CM
In Commercial Distribution

  • 15420045509962 ()
  • 25420045509969 ()
EVIVA_CALIBRATE_13CM

  • Mammographic stereotactic biopsy system

Eviva - 15420045509948

PRODUCT, BUSHING, GE, EVIVA
Hologic, Inc.
EVIVA_BUSHING_GE
In Commercial Distribution

  • 15420045509948 ()
  • 25420045509945 ()
EVIVA_BUSHING_GE

  • Mammographic stereotactic biopsy system

Eviva - 15420045509931

No Description
Hologic, Inc.
EVIVA_STX_KIT_GIOTTO
In Commercial Distribution

  • 15420045509931 ()


  • Mammographic stereotactic biopsy system

Eviva - 15420045509924

No Description
Hologic, Inc.
EVIVA_STX_KIT_INSPIR
In Commercial Distribution

  • 15420045509924 ()


  • Mammographic stereotactic biopsy system

Eviva - 15420045509917

No Description
Hologic, Inc.
Eviva_STX_Kit_Opdima
In Commercial Distribution

  • 15420045509917 ()


  • Mammographic stereotactic biopsy system

Eviva - 15420045509900

No Description
Hologic, Inc.
Eviva_STX_Kit_Affirm
In Commercial Distribution

  • 15420045509900 ()


  • Mammographic stereotactic biopsy system

Eviva - 15420045509894

No Description
Hologic, Inc.
Eviva_STX_KIT_GEL-V
In Commercial Distribution

  • 15420045509894 ()


  • Mammographic stereotactic biopsy system

Eviva - 15420045509887

No Description
Hologic, Inc.
Eviva_STX_KIT_GEVER
In Commercial Distribution

  • 15420045509887 ()


  • Mammographic stereotactic biopsy system

Eviva - 15420045509870

No Description
Hologic, Inc.
Eviva_STX_KIT_GELAT
In Commercial Distribution

  • 15420045509870 ()


  • Mammographic stereotactic biopsy system

Eviva - 15420045509863

No Description
Hologic, Inc.
Eviva_STX_KIT_SLOC
In Commercial Distribution

  • 15420045509863 ()


  • Mammographic stereotactic biopsy system

Eviva - 15420045509856

No Description
Hologic, Inc.
Eviva_STX_KIT_MTEST
In Commercial Distribution

  • 15420045509856 ()


  • Mammographic stereotactic biopsy system

ATEC - 15420045509849

No Description
Hologic, Inc.
ATEC STXFISCHER
In Commercial Distribution

  • 15420045509849 ()


  • Mammographic stereotactic biopsy system

ATEC - 15420045509832

No Description
Hologic, Inc.
ATEC STX-2
In Commercial Distribution

  • 15420045509832 ()


  • Mammographic stereotactic biopsy system

ATEC - 15420045509825

No Description
Hologic, Inc.
ATEC STX-1
In Commercial Distribution

  • 15420045509825 ()


  • Mammographic stereotactic biopsy system

ATEC - 15420045509818

No Description
Hologic, Inc.
SR3000-04
In Commercial Distribution

  • 15420045509818 ()


  • Mammographic stereotactic biopsy system

ATEC - 15420045509801

No Description
Hologic, Inc.
SR3000-01
In Commercial Distribution

  • 15420045509801 ()


  • Mammographic stereotactic biopsy system

ATEC - 15420045509795

No Description
Hologic, Inc.
SR3090-01
In Commercial Distribution

  • 15420045509795 ()


  • Mammographic stereotactic biopsy system

ATEC - 15420045509788

No Description
Hologic, Inc.
SR3060-01
In Commercial Distribution

  • 15420045509788 ()


  • Mammographic stereotactic biopsy system

Eviva - 15420045509771

ADAPTER ASSEMBLY, EVIVA, GE, BOXED
Hologic, Inc.
FAB-06337
In Commercial Distribution

  • 15420045509771 ()
  • 25420045509778 ()
FAB-06337

  • Mammographic stereotactic biopsy system

Eviva - 15420045509764

PRODUCT, HOLDER, NEEDLE GUIDE, EVIVA
Hologic, Inc.
EVIVA_NG_HOLDER
In Commercial Distribution

  • 15420045509764 ()
  • 25420045509761 ()
EVIVA_NG_HOLDER

  • Mammographic stereotactic biopsy system

Eviva - 15420045509757

PRODUCT, BRACKET, STYLET, EVIVA
Hologic, Inc.
EVIVA_STYLET_BRACKET
In Commercial Distribution

  • 15420045509757 ()
  • 25420045509754 ()
EVIVA_STYLET_BRACKET

  • Mammographic stereotactic biopsy system

Eviva - 15420045509740

PRODUCT, ADAPTER, MAMMOTEST, EVIVA
Hologic, Inc.
EVIVA_ADAPTER_MTEST
In Commercial Distribution

  • 15420045509740 ()
  • 25420045509747 ()
EVIVA_ADAPTER_MTEST

  • Mammographic stereotactic biopsy system

Eviva - 15420045509733

No Description
Hologic, Inc.
Eviva_STX_KIT_13cm
In Commercial Distribution

  • 15420045509733 ()


  • Mammographic stereotactic biopsy system

Eviva - 15420045509726

PRODUCT, EVIVA, ADAPTER
Hologic, Inc.
EVIVA_ADAPTER
In Commercial Distribution

  • 15420045509726 ()
  • 25420045509723 ()
EVIVA_ADAPTER

  • Mammographic stereotactic biopsy system

Brevera Breast Biopsy System - 15420045507852

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

  • 15420045507852 ()
  • 25420045507859 ()
BREVADPTRG

  • Mammographic stereotactic biopsy system

Brevera Breast Biopsy System - 15420045507838

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

Brevera Breast Biopsy System - 15420045507821

Stylet Bracket
Hologic, Inc.
BREVSTYLBRKT
In Commercial Distribution

  • 15420045507821 ()
  • 25420045507828 ()
BREVSTYLBRKT

  • Mammographic stereotactic biopsy system

Brevera Breast Biopsy System - 15420045507807

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

Brevera Breast Biopsy System - 15420045507777

Single-use, disposable needle for acquiring biopsy specimens.
Hologic, Inc.
BREV09
Not in Commercial Distribution

  • 15420045507777 ()
  • 35420045507771 ()
BREV09

  • Mammographic stereotactic biopsy system
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