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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MasterScreen IOS
Jaeger Medical GmbH
V-176420-03
Not in Commercial Distribution

  • 04250892900445 ()
V-176420-03

  • Pulmonary function analysis system, adult
RMDpulse (iOS)
RESMED CORP.
22253
In Commercial Distribution

  • 00840193400030 ()


  • Ventilator application software
G6 iOS
Dexcom, Inc.
SW11677
In Commercial Distribution

  • 00386270000804 ()


  • Percutaneous interstitial fluid glucose monitoring system, electrochemical
No Description
Thought Technology Ltd.
SA4515
In Commercial Distribution

  • 07540191000630 ()


  • Psychophysiological biofeedback system
A native iOS and Android mobile application also compatible with iPad. It is used to: • Locate patients according to patient ID • Locate scheduled procedures by connecting to modality worklist • Capture videos, images and audio files to be included in the study case. • Add notes and tags to each file (asset). • Upload any file to the Orpheus System • Manually or automatically delete files from the file library
ORPHEUS MEDICAL LTD
01
In Commercial Distribution

  • 07290017025100 ()
MLL-EG30001

  • Radiology information system application software
Navina Smart Transanal Irrigation. Bowel diary APP
Wellspect AB
75750
In Commercial Distribution

75750

  • Rectal irrigation system application software
Navina Smart Transanal Irrigation. Bowel diary APP
Wellspect AB
75750
Not in Commercial Distribution

  • 07392532242373 ()
75750

  • Rectal irrigation system application software
Eversense NOW Remote Monitoring mobile application (iOS) is intended to be a secondary device used to remotely view an Eversense CGM System user’s glucose information.
SENSEONICS, INCORPORATED
FG-5901-01-300
In Commercial Distribution

  • 00817491021267 ()
FG-5901-01-300

  • Implantable glucose monitoring system
SH5/H56 H5/H5 SCAL #6 HDL 1P
Peter Brasseler Holdings, LLC
5023409U0
In Commercial Distribution

  • 00887919682066 ()


  • Manual dental scaler, reusable
Extra Large Back Table Cover, 94 X 58, LML Barcode, Barrier 82X27
Lac-Mac Limited
025ZS
In Commercial Distribution

  • 00627755250667 ()

  • Height: 58 Inch
  • Width: 94 Inch
025ZS

  • Patient surgical drape, reusable
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