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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LUX-Dx Clinic Assistant app (Mobile application)
BOSTON SCIENTIFIC CORPORATION
622935-100
In Commercial Distribution

  • 00802526607615 ()
622935-100

  • Implantable cardiac device management application software
SFW 9735762 APP STEALTH S8 APPLICATION
MEDTRONIC NAVIGATION, INC.
9735762
In Commercial Distribution

  • 00763000125295 ()


  • Multi-purpose stereotactic surgery system
SFW 9735762 APP STEALTH S8 APPLICATION
MEDTRONIC NAVIGATION, INC.
9735762
In Commercial Distribution

  • 00763000063177 ()


  • Multi-purpose stereotactic surgery system
9340 2W INFBAL VLV MRI APP
HANS RUDOLPH, INC.
9340
Not in Commercial Distribution

  • 00817136024448 ()
CR1819

  • Pulmonary function valve
FreeStyle Libre 3 iOS App US
ABBOTT DIABETES CARE INC
72077-01
In Commercial Distribution

  • 00357599817008 ()
72077-01

  • Percutaneous interstitial fluid glucose monitoring system, electrochemical
FreeStyle Libre 3 Android App US
ABBOTT DIABETES CARE INC
72075-01
In Commercial Distribution

  • 00357599816001 ()
72075-01

  • Percutaneous interstitial fluid glucose monitoring system, electrochemical
FreeStyle Libre 2 App iOS US
ABBOTT DIABETES CARE INC
71926-01
In Commercial Distribution

  • 00357599810009 ()
71926-01

  • Percutaneous interstitial fluid glucose monitoring system, electrochemical
FreeStyle Libre 2 App Android US
ABBOTT DIABETES CARE INC
71857-01
In Commercial Distribution

  • 00357599809003 ()
71857-01

  • Percutaneous interstitial fluid glucose monitoring system, electrochemical
SOFTWARE 9734472 SONONAV CAL APP FOR SC
MEDTRONIC NAVIGATION, INC.
9734472
In Commercial Distribution

  • 00643169183407 ()


  • Multi-purpose stereotactic surgery system
DreamMapper App iOS, Asia-Pacific Instance, version 2.17
Respironics, Inc.
2.17
In Commercial Distribution

  • 00606959054288 ()
1127959

  • Self-care monitoring/reporting software
DreamMapper App iOS, EMEA Instance, version 2.17
Respironics, Inc.
2.17
In Commercial Distribution

  • 00606959054271 ()
1128264

  • Self-care monitoring/reporting software
https://gudid.fda.gov/gudid/app/admin/udi/recordDetails.xhtml#
FLEXICARE MEDICAL LIMITED
038-94-620U
In Commercial Distribution

  • 05055788777694 ()


  • Laryngeal mask airway, single-use
OB V2 RING KIT TI LG-No App
OSSUR AMERICAS, INC.
515500V2
Not in Commercial Distribution

  • 05690977308695 ()
515500V2

  • Cervical spine immobilization head ring
OB V2 RING KIT TI STD-No App
OSSUR AMERICAS, INC.
515400V2
Not in Commercial Distribution

  • 05690977308688 ()
515400V2

  • Cervical spine immobilization head ring
OB V2 RING KIT TI SM-No App
OSSUR AMERICAS, INC.
515300V2
Not in Commercial Distribution

  • 05690977308671 ()
515300V2

  • Cervical spine immobilization head ring
Rabbit Polyclonal Anti-Human Amyloid Precursor Protein (APP)
RICHARD-ALLAN SCIENTIFIC COMPANY
RB-9023-R7
In Commercial Distribution

  • 00673693398602 ()

  • Total Volume: 7 Milliliter


  • Immunohistochemistry antibody detection IVD, kit, enzyme immunohistochemistry
Rabbit Polyclonal Anti-Human Amyloid Precursor Protein (APP)
RICHARD-ALLAN SCIENTIFIC COMPANY
RB-9023-P1
In Commercial Distribution

  • 00673693398572 ()

  • Total Volume: 0.5 Milliliter


  • Immunohistochemistry antibody detection IVD, kit, enzyme immunohistochemistry
Rabbit Polyclonal Anti-Human Amyloid Precursor Protein (APP)
RICHARD-ALLAN SCIENTIFIC COMPANY
RB-9023-P0
In Commercial Distribution

  • 00673693398565 ()

  • Total Volume: 0.1 Milliliter


  • Immunohistochemistry antibody detection IVD, kit, enzyme immunohistochemistry
Rabbit Polyclonal Anti-Human Amyloid Precursor Protein (APP)
RICHARD-ALLAN SCIENTIFIC COMPANY
RB-9023-P
In Commercial Distribution

  • 00673693398558 ()

  • Total Volume: 1 Milliliter


  • Immunohistochemistry antibody detection IVD, kit, enzyme immunohistochemistry
Navina Smart Transanal Irrigation. Bowel diary APP
Wellspect AB
75751
Not in Commercial Distribution

  • 07392532242380 ()
75751

  • Rectal irrigation system application software
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