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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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The HandX is intended to assist in the accurate control of HX laparoscopic Instruments including needle holder and grasper, for endoscopic manipulation of tissue, including grasping, approximation, ligation, suturing, during laparoscopic surgical procedures. It is intended to be used by trained physicians in an operating room environment in accordance with its Instructions For Use.
HUMAN XTENSIONS LTD
20-30-019-01
In Commercial Distribution

  • 17290017376001 ()
  • 07290017376004 ()
20-30-019-01

  • Endoscopic electromechanical surgical system
No Description
medimaps group SA
3
In Commercial Distribution

  • B214OSPTM3 ()


  • Bone densitometry ultrasound phantom, test object
  • Bone densitometry x-ray phantom, test object
  • Diagnostic ultrasound phantom, test object
  • CT phantom, test object
  • General-purpose diagnostic x-ray phantom, test object
  • Multi-modality diagnostic imaging phantom, test object
SW MSW001 LINQ MOBILE MANAGER USA
MEDTRONIC, INC.
MSW001
In Commercial Distribution

  • 00643169545519 ()


  • Implantable cardiac device management application software
SW MSW002 LINQ PROGRAMMER iOS APP
MEDTRONIC, INC.
MSW002
In Commercial Distribution

  • 00643169636651 ()


  • Implantable cardiac device management application software
SW D00U002 CARELINK SMARTSYNC PSA APP
MEDTRONIC, INC.
D00U002
In Commercial Distribution

  • 00643169833753 ()


  • Implantable cardiac device management application software
SW M01A02 CARELINK SMARTSYNC IOS
MEDTRONIC, INC.
M01A02
In Commercial Distribution

  • 00643169833739 ()


  • Implantable cardiac device management application software
SW M01G02 CARELINK SMARTSYNC ANDROID
MEDTRONIC, INC.
M01G02
In Commercial Distribution

  • 00643169833715 ()


  • Implantable cardiac device management application software
INFOSMART CD
FISHER & PAYKEL HEALTHCARE LIMITED
900SW100
In Commercial Distribution

  • 09420012424990 ()
900SW100

  • Ventilator application software
No Description
NEUROLOGICA CORP.
10-01527-001
Not in Commercial Distribution

  • 10815411020755 ()


  • CT phantom, test object
Ultrasound -guided intrauterine electrosurgical system ultrasound control unit
Gynesonics, Inc.
USCON-2200
In Commercial Distribution

  • 10817929020197 ()
USCON-2200

  • Ultrasound-guided intrauterine radio-frequency ablation system ultrasound control unit
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