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
BIOTRONIK SE & Co. KG
3.60
Not in Commercial Distribution

  • 04035479186128 ()
488670

  • Implantable cardiac device management application software
No Description
BIOTRONIK SE & Co. KG
3.59
Not in Commercial Distribution

  • 04035479184636 ()
486092

  • Implantable cardiac device management application software
No Description
BIOTRONIK SE & Co. KG
484448
In Commercial Distribution

  • 04035479184445 ()
484448

  • Implantable cardiac device management application software
No Description
BIOTRONIK SE & Co. KG
2.7
In Commercial Distribution

  • 04035479183271 ()
482213

  • Implantable cardiac device management application software
No Description
BIOTRONIK SE & Co. KG
3.58
Not in Commercial Distribution

  • 04035479183264 ()
482190

  • Implantable cardiac device management application software
No Description
BIOTRONIK SE & Co. KG
3.57
Not in Commercial Distribution

  • 04035479182045 ()
480113

  • Implantable cardiac device management application software
No Description
BIOTRONIK SE & Co. KG
3.54
Not in Commercial Distribution

  • 04035479177942 ()
472068

  • Implantable cardiac device management application software
No Description
BIOTRONIK SE & Co. KG
3.53
Not in Commercial Distribution

  • 04035479176587 ()
466610

  • Implantable cardiac device management application software
No Description
BIOTRONIK SE & Co. KG
3.50
Not in Commercial Distribution

  • 04035479176143 ()
459761

  • Implantable cardiac device management application software
No Description
BIOTRONIK SE & Co. KG
3.51
Not in Commercial Distribution

  • 04035479175559 ()
462086

  • Implantable cardiac device management application software
No Description
NEUROLOGICA CORP.
10-01527-001
Not in Commercial Distribution

  • 10815411020755 ()


  • CT phantom, test object
K-BALL
S.M.A.I.O
01BK0001
In Commercial Distribution

  • 03701313007942 ()
01BK0001

  • 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
No Description
BIOTRONIK SE & Co. KG
2.5
In Commercial Distribution

  • 04035479180461 ()
469464

  • Implantable cardiac device management application software
No Description
BIOTRONIK SE & Co. KG
3.55
Not in Commercial Distribution

  • 04035479179779 ()
474019

  • Implantable cardiac device management application software
No Description
BIOTRONIK SE & Co. KG
3.49
Not in Commercial Distribution

  • 04035479169466 ()
455929

  • Implantable cardiac device management application software
No Description
BIOTRONIK SE & Co. KG
3.48
Not in Commercial Distribution

  • 04035479168773 ()
453795

  • Implantable cardiac device management application software
No Description
BIOTRONIK SE & Co. KG
3.47
Not in Commercial Distribution

  • 04035479167509 ()
451625

  • Implantable cardiac device management application software
ResScan v7.0
RESMED CORP.
31337
In Commercial Distribution

  • 00840193400191 ()


  • Ventilator application software
AirView
RESMED CORP.
22240
In Commercial Distribution

  • 00840193400108 ()
22240

  • Ventilator application software
RMDpulse (iOS)
RESMED CORP.
22253
In Commercial Distribution

  • 00840193400030 ()


  • Ventilator application software
RMDpulse (Android)
RESMED CORP.
22254
In Commercial Distribution

  • 00840193400023 ()


  • Ventilator application software
IE Sync Trigger Software Update
Covidien LP
980IESYNC
In Commercial Distribution

  • 10884521211551 ()


  • Ventilator application software
NIV plus Software Upgrade Option US;For 980 Series Ventilator
Covidien LP
980NIVPLUS-US
In Commercial Distribution

  • 10884521817609 ()


  • Ventilator application software
IE Sync Trigger Upgrade Option US;For 980 Series Ventilator
Covidien LP
980IESYNC-US
In Commercial Distribution

  • 10884521817593 ()


  • Ventilator application software
High Flow O2 Therapy Upgrade Option US;For 980 Series Ventilator
Covidien LP
980HFO2T-US
In Commercial Distribution

  • 10884521817586 ()


  • Ventilator application software
KIT,AVEA UPGRADE UIM & SOFTWARE
Carefusion Corporation
12285
Not in Commercial Distribution

  • 10846446000979 ()


  • Ventilator application software
KIT,AVEA UPGRADE GDE & SOFTWARE
Carefusion Corporation
12284-PMN
Not in Commercial Distribution

  • 10846446064872 ()
12284-PMN

  • Ventilator application software
KIT,AVEA UPGRADE GDE,UIM & SOFTWARE
Carefusion Corporation
12283-PMN
Not in Commercial Distribution

  • 10846446064865 ()


  • Ventilator application software
AVEA NIMV+VG SW KEY
Carefusion Corporation
63865
Not in Commercial Distribution

  • 10846446017564 ()


  • Ventilator application software
ResScan V7.0.2
RESMED CORP.
31339
In Commercial Distribution

  • 08401934313396 ()


  • Ventilator application software
ResScan v7.0.1
RESMED CORP.
31338
In Commercial Distribution

  • 08401934313389 ()


  • Ventilator application software
High Resolution Module
Providus Holdings, Inc.
CTP764
In Commercial Distribution

  • 00812266031403 ()
CTP764

  • CT phantom, test object
Liver Phantom, Simplified Torso Section with Image Quality Test Inserts
Providus Holdings, Inc.
CCT288
In Commercial Distribution

  • 00812266030581 ()
CCT288

  • CT phantom, test object
Low Contrast MITA Head Phantom, MITA CT IQ Task Group Low Contrast Head Phantom
Providus Holdings, Inc.
CCT191
In Commercial Distribution

  • 00812266030574 ()
CCT191

  • CT phantom, test object
Low Contrast MITA Body Phantom, MITA CT IQ Task Group Low Contrast Body Phantom
Providus Holdings, Inc.
CCT189
In Commercial Distribution

  • 00812266030567 ()
CCT189

  • CT phantom, test object
ATCM Phantom, Automatic Tube Current Modulation Phantom
Providus Holdings, Inc.
CCT228
In Commercial Distribution

  • 00812266030550 ()
CCT228

  • CT phantom, test object
The Corgi® Phantom is a modular phantom designed for evaluation of cone beam imaging systems.
Providus Holdings, Inc.
CGI014
In Commercial Distribution

  • 00812266030529 ()
CGI014

  • CT phantom, test object
16cm OD housing and mount
Providus Holdings, Inc.
CTP541
In Commercial Distribution

  • 00812266030512 ()
CTP541

  • CT phantom, test object
Catphan® case
Providus Holdings, Inc.
CTP451
In Commercial Distribution

  • 00812266030505 ()
CTP451

  • CT phantom, test object
Catphan® 600 mount assembly
Providus Holdings, Inc.
CTP627
In Commercial Distribution

  • 00812266030499 ()
CTP627

  • CT phantom, test object
Catphan® 600 housing
Providus Holdings, Inc.
CTP623
In Commercial Distribution

  • 00812266030482 ()
CTP623

  • CT phantom, test object
30 line pair high resolution module
Providus Holdings, Inc.
CTP714
In Commercial Distribution

  • 00812266030475 ()
CTP714

  • CT phantom, test object
Geometry sensitometry and point source module
Providus Holdings, Inc.
CTP682
In Commercial Distribution

  • 00812266030468 ()
CTP682

  • CT phantom, test object
40mm bead geometry module
Providus Holdings, Inc.
CTP591
In Commercial Distribution

  • 00812266030451 ()
CTP591

  • CT phantom, test object
Subslice and supra-slice low contrast module
Providus Holdings, Inc.
CTP515
In Commercial Distribution

  • 00812266030444 ()
CTP515

  • CT phantom, test object
Solid image uniformity module
Providus Holdings, Inc.
CTP486
In Commercial Distribution

  • 00812266030437 ()
CTP486

  • CT phantom, test object
21 line pair high resolution and point source module
Providus Holdings, Inc.
CTP528
In Commercial Distribution

  • 00812266030420 ()
CTP528

  • CT phantom, test object
Slice width, sensitometry and pixel size module
Providus Holdings, Inc.
CTP404
In Commercial Distribution

  • 00812266030413 ()
CTP404

  • CT phantom, test object
Catphan® 608, Complete Catphan® including housing and case
Providus Holdings, Inc.
CTP608
In Commercial Distribution

  • 00812266030406 ()
CTP608

  • CT phantom, test object
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