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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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Non Contact Infrared Body Thermometer
Hetaida Technology Co., Ltd
HTD8813C
Not in Commercial Distribution

  • 17958909771661 ()
  • 07958909771664 ()


  • Infrared patient thermometer, skin
Nasal Wash. Nose drug administration device intended specifically to administer medicinal substances or saline solutions to treat nose
FLAEM NUOVA SPA
P0709EM
In Commercial Distribution

  • 08018294012793 ()
DR12P00

  • Nasal irrigation set, home-use
The device is designed to perform radiographic x-ray examinations on pediatric and adult patients, in all patient treatment areas
MICRO-X LIMITED
Rover
In Commercial Distribution

  • 00935712300004 ()
MXU-RV01

  • Mobile basic diagnostic x-ray system, digital
DirectLink™ ICP Module
Integra LifeSciences Switzerland Sàrl
826828
In Commercial Distribution

82-6828

  • Intracranial pressure monitor
The PhotonBlade is an RF device coupled with illumination that is indicated for cutting and coagulation of soft tissue during surgical procedures. It is intended to be used with a variety of standard commercially available electrosurgical units.
STRYKER CORPORATION
PB1
In Commercial Distribution

  • 00816728020158 ()
PB1

  • Open-surgery electrosurgical handpiece/electrode, monopolar, single-use
The PhotonBlade with Adaptive Smoke Evacuation is a monopolar RF device coupled with illumination that is indicated for cutting and coagulation of tissue during general surgical procedures and for removing smoke generated by electrosurgery when used in conjunction with an effective smoke evacuation system.
STRYKER CORPORATION
PB2SE
In Commercial Distribution

  • 00816728021261 ()
PB2SE

  • Open-surgery electrosurgical handpiece/electrode, monopolar, single-use
No Description
ORTHOSENSOR INC
VERASENSE for Smith & Nephew Legion PS size 3-4
Not in Commercial Distribution

  • 00816818021720 ()
SNN-LGNPS34

  • Arthroplasty force sensor
No Description
ORTHOSENSOR INC
VERASENSE for Smith & Nephew Legion PS size 1-2
Not in Commercial Distribution

  • 00816818021713 ()
SNN-LGNPS12

  • Arthroplasty force sensor
No Description
ORTHOSENSOR INC
VERASENSE for Smith & Nephew Legion CR size 7-8
Not in Commercial Distribution

  • 00816818021706 ()
SNN-LGNCR78

  • Arthroplasty force sensor
No Description
ORTHOSENSOR INC
VERASENSE for Smith & Nephew Legion CR size 5-6
Not in Commercial Distribution

  • 00816818021690 ()
SNN-LGNCR56

  • Arthroplasty force sensor
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