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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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ViewPoint 6 v6.14
GE Healthcare GmbH
6. ver14
In Commercial Distribution

  • 00195278517340 ()
H47591YA

  • Medical image management system
  • Radiological PACS software
Sentiero AuDX PRO Set: Content: 1. Sentiero Diagnostic device AN100098-AUP 2. Carrying case AN100928 3. Inlay AN100677 4. Probe EP-DP Path long AN100028-US 5. Accessory box Combo AB-03 AN100261-BL 6. TEOAE Software AN100109 7. DPOAE Software AN100110 8. FMDPOAE Software AN100536 9. DPHiRes Software AN100537 10. Software label printer AN100414 11. PC Patient Management Software AN100116 12. USB data cable AN100089 13. USB stick Bio-Logic AN100724-BL 14. Power supply Sentiero AN101013+AN100993-USA 15. Manual Bio-Logic AN100904-EN-BL
PATH medical GmbH
8-04-16530
In Commercial Distribution

  • 04260223143489 ()
100250-BL-US4

  • Evoked-potential audiometer
Diagnostic ultrasound system
FUJIFILM SONOSITE, INC.
P17000-15
In Commercial Distribution

  • 00841517100032 ()


  • General-purpose ultrasound imaging system
  • Breast ultrasound imaging system
  • Obstetrical/gynaecological ultrasound imaging system
  • Cardiovascular ultrasound imaging system
No Description
Onera B.V.
01.00
In Commercial Distribution

  • 08720256698197 ()
ONERA STS1 STATION SOFTWARE

  • Polysomnography analyser
t:connect Mobile Application (iOS)
Tandem Diabetes Care, Inc.
1004128
In Commercial Distribution

  • 00850006613274 ()


  • Ambulatory insulin infusion pump software, data-display
t:connect Mobile Application (Android)
Tandem Diabetes Care, Inc.
1004127
In Commercial Distribution

  • 00850006613267 ()


  • Ambulatory insulin infusion pump software, data-display
No Description
KONAN MEDICAL, INC.
CD-15
In Commercial Distribution

  • 04582275250404 ()


  • Cell morphology analyser IVD, manual
Bionic Circle App, Android
Beta Bionics, Inc.
BOM000083
In Commercial Distribution

  • 00850050080176 ()
BB5002

  • Ambulatory insulin infusion pump software, data-display
Bionic Circle App, iOS
Beta Bionics, Inc.
BOM000082
In Commercial Distribution

  • 00850050080169 ()
BB5001

  • Ambulatory insulin infusion pump software, data-display
No Description
Overjet, Inc.
v1
In Commercial Distribution

  • 00860005586370 ()


  • Dental x-ray image interpretive software
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