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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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No Description
L A P GMBH LASER APPLIKATIONEN
LUNA Distribution Box
In Commercial Distribution

  • 04260590372581 ()
0018364-0008

  • Radiological video camera patient positioning/tracking system
No Description
DIERS International GmbH
n/a
In Commercial Distribution

  • 04260242060194 ()


  • Radiological video camera patient positioning/tracking system
No Description
DIERS International GmbH
II
In Commercial Distribution

  • 04260242060101 ()


  • Radiological video camera patient positioning/tracking system
No Description
DIERS International GmbH
III 4D
In Commercial Distribution

  • 04260242060019 ()


  • Radiological video camera patient positioning/tracking system
ON-Q* Fixed Flow Pump Kits With ON-Q* Soaker* Catheter
Avanos Medical, Inc.
45082
In Commercial Distribution

  • 10193494450820 ()
  • 00193494450823 ()

  • Total Volume: 400 Milliliter
  • Fill Volume (ml)
PS6508-N

  • Cardiac pulse generator software
The intended use of the device is to identify the patient and patient specific accessories and to guide the positioning of patients and accessories for radiosurgery or radiotherapy prodedures. The only location where the device is used is the radiologic diagnostic and radiation therapy department.
humediQ global GmbH
1.7
In Commercial Distribution

  • EHUQHQ0100707 ()
HQ01007

  • Radio-frequency identification patient positioning/tracking system application software
No Description
VISION RT LIMITED
AlignRT
Not in Commercial Distribution

  • B120ALIGNRT0 ()
AlignRT

  • Radiological video camera patient positioning/tracking system
LATITUDE Consult™ System
BOSTON SCIENTIFIC CORPORATION
6294
In Commercial Distribution

  • 00802526562914 ()


  • Cardiac pulse generator software
LATITUDE Consult™ System
BOSTON SCIENTIFIC CORPORATION
6294
In Commercial Distribution

  • 00802526562907 ()


  • Cardiac pulse generator software
BD FACSDiva™ Software v 9.2
Becton, Dickinson And Company
665421
In Commercial Distribution

  • 00382906654212 ()
665421

  • Laboratory instrument/analyser application software IVD
SOFTWARE 9735345 INSTALL MEDIA TOOLS DB
MEDTRONIC NAVIGATION, INC.
9735345
In Commercial Distribution

  • 00643169363847 ()


  • Multi-purpose stereotactic surgery system
SOFTWARE MMT-7335 V3.2 CARELINK PRO EN
MEDTRONIC MINIMED, INC.
MMT-7335
Not in Commercial Distribution

  • 00643169175341 ()


  • Patient health record information system application software
SOFTWARE MMT-7335 V3.4 CARELINK PRO EN
MEDTRONIC MINIMED, INC.
MMT-7335
In Commercial Distribution

  • 00643169288409 ()


  • Patient health record information system application software
SOFTWARE KIT 9733652 FUSION ENT - EU-SE
MEDTRONIC NAVIGATION, INC.
9733652
Not in Commercial Distribution

  • 00643169491823 ()


  • ENT stereotactic surgery system
SOFTWARE KIT 9733652 FUSION ENT - EU-E
MEDTRONIC NAVIGATION, INC.
9733652
Not in Commercial Distribution

  • 00643169491816 ()


  • ENT stereotactic surgery system
SOFTWARE KIT 9733652 FUSION ENT - SCAND
MEDTRONIC NAVIGATION, INC.
9733652
In Commercial Distribution

  • 00643169491809 ()


  • ENT stereotactic surgery system
SOFTWARE KIT 9733652 FUSION ENT - EU-SW
MEDTRONIC NAVIGATION, INC.
9733652
In Commercial Distribution

  • 00643169491793 ()


  • ENT stereotactic surgery system
SOFTWARE KIT 9733652 FUSION ENT - EU-NW
MEDTRONIC NAVIGATION, INC.
9733652
Not in Commercial Distribution

  • 00643169491786 ()


  • ENT stereotactic surgery system
SOFTWARE KIT 9733652 FUSION ENT US
MEDTRONIC NAVIGATION, INC.
9733652
In Commercial Distribution

  • 00643169491779 ()


  • ENT stereotactic surgery system
SOFTWARE KIT 9733652XOM FUSION ENT US
MEDTRONIC NAVIGATION, INC.
9733652XOM
Not in Commercial Distribution

  • 00643169491762 ()


  • ENT stereotactic surgery system
SOFTWARE KIT 9733937 SYNERGY CRANIAL S7
MEDTRONIC NAVIGATION, INC.
9733937
In Commercial Distribution

  • 00643169481275 ()


  • Neurological stereotactic surgery system
SOFTWARE KIT 9733652XOM Fusion ENT -EU-E
MEDTRONIC NAVIGATION, INC.
9733652XOM
Not in Commercial Distribution

  • 00643169492240 ()


  • ENT stereotactic surgery system
* INACTIVE Software Upgrade, LiDCOunity v1.01 (b1941)
LIDCO LIMITED
Li11177
Not in Commercial Distribution

  • 05060110522941 ()
Li11177

  • General-purpose multi-parameter bedside monitor
* INACTIVE Software Upgrade, LiDCOunity v2.02 (b231)
LIDCO LIMITED
LI11171
Not in Commercial Distribution

  • 05060110522781 ()
LI11171

  • General-purpose multi-parameter bedside monitor
* INACTIVE Software Upgrade, LiDCOunity v2.03 (b301)
LIDCO LIMITED
Li11178
Not in Commercial Distribution

  • 05060110522767 ()
Li11178

  • General-purpose multi-parameter bedside monitor
* INACTIVE Software Upgrade, LiDCOunity v1.01 (b1935)
LIDCO LIMITED
Li11150
Not in Commercial Distribution

  • 05060110522606 ()
Li11150

  • General-purpose multi-parameter bedside monitor
Licence, Software, LiDCOrapid (Rapid, BIS, Ext)
LIDCO LIMITED
Li11080
In Commercial Distribution

  • 05060110522378 ()
Li11080

  • General-purpose multi-parameter bedside monitor
Licence, Software, LiDCOplus (Plus, Li, Ext)
LIDCO LIMITED
Li11078
In Commercial Distribution

  • 05060110522354 ()
Li11078

  • General-purpose multi-parameter bedside monitor
* INACTIVE Software Upgrade, LiDCOrapid v2.06 (b1326)
LIDCO LIMITED
Li11056
Not in Commercial Distribution

  • 05060110522187 ()
Li11056

  • General-purpose multi-parameter bedside monitor
* INACTIVE Software Upgrade, LiDCOrapid v2.06 (b1324)
LIDCO LIMITED
Li10979
Not in Commercial Distribution

  • 05060110522125 ()
Li10979

  • General-purpose multi-parameter bedside monitor
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