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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SW APP A52300 OASIS PATIENT GU
MEDTRONIC, INC.
A52300
In Commercial Distribution

  • 00763000517199 ()


  • Multiple active implantable device programmer
SW APP A51300 OASIS CLINICIAN GU
MEDTRONIC, INC.
A51300
In Commercial Distribution

  • 00763000517182 ()


  • Multiple active implantable device programmer
SFW 9735762 APP STEALTH S8 APPLICATION
MEDTRONIC NAVIGATION, INC.
9735762
In Commercial Distribution

  • 00763000368494 ()


  • Multi-purpose stereotactic surgery system
SW APP A52200 GU PATIENT PERFICIO
MEDTRONIC, INC.
A52200
In Commercial Distribution

  • 00763000159092 ()


  • Multiple active implantable device programmer
FeetMe Rehabilitation mobile application corresponding to iOS version 1.Y.Z
FEETME
1
In Commercial Distribution

  • 03760349820024 ()


  • Biomechanical function analysis/rehabilitation software
IOS Base Replica Nobel Biocare N1™ Base Tri RP
Nobel Biocare AB
301025
In Commercial Distribution

  • 07332747163148 ()
301025

  • Dental implant suprastructure, temporary, preformed, single-use
IOS Base Replica Nobel Biocare N1™ Base Tri NP
Nobel Biocare AB
301024
In Commercial Distribution

  • 07332747163131 ()
301024

  • Dental implant suprastructure, temporary, preformed, single-use
IOS Healing Abutment Nobel Biocare N1™ Base Tri RP
Nobel Biocare AB
300992
In Commercial Distribution

  • 07332747162967 ()
300992

  • Dental implant suprastructure, temporary, preformed, single-use
IOS Healing Abutment Nobel Biocare N1™ Base Tri NP
Nobel Biocare AB
300991
In Commercial Distribution

  • 07332747162950 ()
300991

  • Dental implant suprastructure, temporary, preformed, single-use
IOS Base Replica Nobel Biocare N1™ Base Tri RP
Nobel Biocare AB
301025
In Commercial Distribution

  • 07332747177169 ()
301025

  • Dental implant suprastructure, temporary, preformed, single-use
IOS Base Replica Nobel Biocare N1™ Base Tri NP
Nobel Biocare AB
301024
In Commercial Distribution

  • 07332747177152 ()
301024

  • Dental implant suprastructure, temporary, preformed, single-use
IOS Base Replica Nobel Biocare N1™ Base Tri RP
Nobel Biocare AB
301025
In Commercial Distribution

  • 07332747214406 ()
301025

  • Dental implant suprastructure, temporary, preformed, single-use
IOS Base Replica Nobel Biocare N1™ Base Tri NP
Nobel Biocare AB
301024
In Commercial Distribution

  • 07332747214390 ()
301024

  • Dental implant suprastructure, temporary, preformed, single-use
IOS Healing Abutment Nobel Biocare N1™ Base Tri RP
Nobel Biocare AB
300992
In Commercial Distribution

  • 07332747192797 ()
300992

  • Dental implant suprastructure, temporary, preformed, single-use
IOS Healing Abutment Nobel Biocare N1™ Base Tri NP
Nobel Biocare AB
300991
In Commercial Distribution

  • 07332747192780 ()
300991

  • Dental implant suprastructure, temporary, preformed, single-use
SOFTWARE 9734472 SONONAV CAL APP FOR SC
MEDTRONIC NAVIGATION, INC.
9734472
In Commercial Distribution

  • 00643169183407 ()


  • Multi-purpose stereotactic surgery system
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
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
App Control for ACRL-9100 Device v.1
COMPASS HEALTH BRANDS CORP.
ACRL-9100APP
In Commercial Distribution



  • Physical therapy transcutaneous neuromuscular electrical stimulation system
App Control for ACRL-9100 Device v.0
COMPASS HEALTH BRANDS CORP.
ACRL-9100APP
Not in Commercial Distribution

  • 00023601091000 ()


  • Physical therapy transcutaneous neuromuscular electrical stimulation system
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
G5 Mobile Android App Stand Alone Software
Dexcom, Inc.
SW10940
In Commercial Distribution

  • 00386270000293 ()


  • Percutaneous interstitial fluid glucose monitoring system, electrochemical
https://gudid.fda.gov/gudid/app/admin/udi/recordDetails.xhtml#
Bio Compression Systems, Inc
G8-3035-SH-M-L
In Commercial Distribution

  • 00812311029119 ()


  • Multi-chamber venous compression system garment, reusable
https://gudid.fda.gov/gudid/app/admin/udi/recordDetails.xhtml#
Bio Compression Systems, Inc
G8-3035-SH-M-L-BT
In Commercial Distribution

  • 00812311020062 ()


  • Multi-chamber venous compression system garment, reusable
A mobile app for HANSATON hearing instruments
Sonova AG
088-5018
In Commercial Distribution

  • 07613389610932 ()


  • Audiometric/hearing device software
APP System, Standard, 220 Volt, 1/ea
Drive Devilbiss Healthcare
14002E-220
Not in Commercial Distribution

  • 10822383227785 ()
  • 00822383227788 ()


  • Alternating-pressure bed mattress overlay system
  • Alternating-pressure inflator
  • Alternating-pressure bed mattress overlay, reusable
https://gudid.fda.gov/gudid/app/admin/udi/recordDetails.xhtml#
MAR COR PURIFICATION, INC.
102M16B2E
In Commercial Distribution

  • 00817492021969 ()

  • Width: 38 Inch
  • Depth: 29 Inch
  • Height: 80.5 Inch
  • Weight: 783 Pound


  • Reverse-osmosis water purification system
APP PAD W/O HEAD & FOOT FLAPS
COMPASS HEALTH BRANDS CORP.
1002
In Commercial Distribution

  • 30815067040170 ()
  • 00815067040179 ()


  • Alternating-pressure bed mattress overlay, reusable
Symphony True LAL & APP Matt Repl Sys
Drive Devilbiss Healthcare
14500
Not in Commercial Distribution

  • 00822383580913 ()


  • Alternating-pressure inflator
  • Alternating-pressure bed mattress overlay, reusable
  • Alternating-pressure bed mattress overlay system
Navina Smart Transanal Irrigation. Bowel diary APP
Wellspect AB
75751
In Commercial Distribution

75751

  • Rectal irrigation system application software
Navina Smart Transanal Irrigation. Bowel diary APP
Wellspect AB
75751
Not in Commercial Distribution

  • 07392532242380 ()
75751

  • Rectal irrigation system application software
SW D00U027 SS LINQ II PLATFORM APP
MEDTRONIC, INC.
D00U027
In Commercial Distribution

  • 00763000891091 ()


  • Implantable cardiac device management application software
SW MMT-8061 INPEN 2.0 ANDROID APP US
MEDTRONIC MINIMED, INC.
MMT-8061
In Commercial Distribution

  • 00763000974596 ()


  • Empty self-injector, mechanical
SW APP A71300 SCS CLINICIAN TRIALING 2.0
MEDTRONIC, INC.
A71300
In Commercial Distribution

  • 00763000533199 ()


  • Multiple active implantable device programmer
SFTWR CSS7201 GRDN MBL APP ANDRD V4.1.1
MEDTRONIC MINIMED, INC.
CSS7201
In Commercial Distribution

  • 00763000381097 ()


  • Patient health record information system application software
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