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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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StealthStation S8 - 00763000852818

SFW 9735762 APP STEALTH S8 V2.1
MEDTRONIC NAVIGATION, INC.
9735762
In Commercial Distribution

  • 00763000852818 ()


  • Multi-purpose stereotactic surgery system

LUX-Dx™ Clinic Assistant app - 00802526607615

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

  • 00802526607615 ()
622935-100

  • Implantable cardiac device management application software

MiniMed™ Mobile - 00763000968175

SFTWR MMT-6102 AHCL APP 2.7 IOS
MEDTRONIC MINIMED, INC.
MMT-6102
In Commercial Distribution

  • 00763000968175 ()


  • Self-care monitoring/reporting software

MiniMed™ Mobile - 00763000968168

SFTWR MMT-6101 AHCL APP 2.7 ANDROID
MEDTRONIC MINIMED, INC.
MMT-6101
In Commercial Distribution

  • 00763000968168 ()


  • Self-care monitoring/reporting software

N/A - 00763000975029

SOFTWARE APP A610 DBS CLINICIAN V5.0
MEDTRONIC, INC.
A610
In Commercial Distribution

  • 00763000975029 ()


  • Multiple active implantable device programmer

MiniMed™ Mobile - 00763000943264

SFTWR MMT-6102 AHCL APP 2.6 IOS
MEDTRONIC MINIMED, INC.
MMT-6102
In Commercial Distribution

  • 00763000943264 ()


  • Self-care monitoring/reporting software

MiniMed™ Mobile - 00763000943257

SFTWR MMT-6101 AHCL APP 2.6 ANDROID
MEDTRONIC MINIMED, INC.
MMT-6101
In Commercial Distribution

  • 00763000943257 ()


  • Self-care monitoring/reporting software

MiniMed™ Mobile - 00763000910150

SFTWR MMT-6102 AHCL APP 2.5 IOS
MEDTRONIC MINIMED, INC.
MMT-6102
In Commercial Distribution

  • 00763000910150 ()


  • Self-care monitoring/reporting software

MiniMed ™ Mobile - 00763000910143

SFTWR MMT-6101 AHCL APP 2.5 ANDROID
MEDTRONIC MINIMED, INC.
MMT-6101
In Commercial Distribution

  • 00763000910143 ()


  • Self-care monitoring/reporting software

MiniMed™ Mobile - 00763000867638

SFTWR MMT-6102 AHCL APP 2.2 IOS
MEDTRONIC MINIMED, INC.
MMT-6102
In Commercial Distribution

  • 00763000867638 ()


  • Self-care monitoring/reporting software

MiniMed ™ Mobile - 00763000867621

SFTWR MMT-6101 AHCL APP 2.2.1 ANDROID
MEDTRONIC MINIMED, INC.
MMT-6101
In Commercial Distribution

  • 00763000867621 ()


  • Self-care monitoring/reporting software

N/A - 00763000612832

SW APP A90300 RECHAGER APPLICATION V2.0
MEDTRONIC, INC.
A90300
In Commercial Distribution

  • 00763000612832 ()


  • Multiple active implantable device programmer

CARESTREAM Image Suite - 60889971055989

IMAGE SUITE / V4 SW MEDICAL APP
CARESTREAM HEALTH, INC.
CARESTREAM Image Suite
In Commercial Distribution

  • 60889971055989 ()
1055987

  • Radiological PACS software

NA - 00763000517199

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

  • 00763000517199 ()


  • Multiple active implantable device programmer

NA - 00763000517182

SW APP A51300 OASIS CLINICIAN GU
MEDTRONIC, INC.
A51300
In Commercial Distribution

  • 00763000517182 ()


  • Multiple active implantable device programmer

MiniMed™ Mobile - 00763000416676

SFTWR MMT-6102 AHCL APP 1.3.3 IOS
MEDTRONIC MINIMED, INC.
MMT-6102
In Commercial Distribution

  • 00763000416676 ()


  • Self-care monitoring/reporting software

MiniMed ™ Mobile - 00763000416669

SFTWR MMT-6101 AHCL APP 1.3.2 ANDROID
MEDTRONIC MINIMED, INC.
MMT-6101
In Commercial Distribution

  • 00763000416669 ()


  • Self-care monitoring/reporting software

Medtronic Navigation - 00763000456986

SFW 9735762 APP STEALTH S8 APPLICATION
MEDTRONIC NAVIGATION, INC.
9735762
In Commercial Distribution

  • 00763000456986 ()


  • Multi-purpose stereotactic surgery system

StealthStation Cranial Software - 00763000368494

SFW 9735762 APP STEALTH S8 APPLICATION
MEDTRONIC NAVIGATION, INC.
9735762
In Commercial Distribution

  • 00763000368494 ()


  • Multi-purpose stereotactic surgery system

SteathStation - 00763000532123

SW 9735762 APP STLTH S8 v2.0.1
MEDTRONIC NAVIGATION, INC.
9735762
In Commercial Distribution

  • 00763000532123 ()


  • Multi-purpose stereotactic surgery system

N/A - 00763000159092

SW APP A52200 GU PATIENT PERFICIO
MEDTRONIC, INC.
A52200
In Commercial Distribution

  • 00763000159092 ()


  • Multiple active implantable device programmer

N/A - 00763000159085

SW APP A51200 GU CLINICIAN PERFICIO
MEDTRONIC, INC.
A51200
In Commercial Distribution

  • 00763000159085 ()


  • Multiple active implantable device programmer

Guardian™ Connect App - 00763000158392

SFTWR CSS7200 GRDN IOS APP V3.2.1
MEDTRONIC MINIMED, INC.
CSS7200
In Commercial Distribution

  • 00763000158392 ()


  • Patient health record information system application software

StealthStation Cranial Software - 00763000125295

SFW 9735762 APP STEALTH S8 APPLICATION
MEDTRONIC NAVIGATION, INC.
9735762
In Commercial Distribution

  • 00763000125295 ()


  • Multi-purpose stereotactic surgery system

InPen Smart Insulin Delivery System - 00763000489960

SOFTWARE MMT-8061 INS PEN ANDROID APP
MEDTRONIC MINIMED, INC.
MMT-8061
In Commercial Distribution

  • 00763000489960 ()


  • Empty self-injector, mechanical

InPen Smart Insulin Delivery System - 00763000489953

SOFTWARE MMT-8060 INSULIN PEN IOS APP
MEDTRONIC MINIMED, INC.
MMT-8060
In Commercial Distribution

  • 00763000489953 ()


  • Empty self-injector, mechanical

N/A - 00763000024024

SW APP A520 GU PATIENT CHRONIC
MEDTRONIC, INC.
A520
In Commercial Distribution

  • 00763000024024 ()


  • Multiple active implantable device programmer

N/A - 00763000024017

SW APP A510 GU CLINICIAN CHRONIC
MEDTRONIC, INC.
A510
In Commercial Distribution

  • 00763000024017 ()


  • Multiple active implantable device programmer

StealthStation - 00763000063177

SFW 9735762 APP STEALTH S8 APPLICATION
MEDTRONIC NAVIGATION, INC.
9735762
In Commercial Distribution

  • 00763000063177 ()


  • Multi-purpose stereotactic surgery system

N/A - 00763000287306

SW APP A72300 SCS PATIENT TRIALING
MEDTRONIC, INC.
A72300
In Commercial Distribution

  • 00763000287306 ()


  • Multiple active implantable device programmer

N/A - 00763000287276

SW APP A71300 SCS CLINICIAN TRIALING
MEDTRONIC, INC.
A71300
In Commercial Distribution

  • 00763000287276 ()


  • Multiple active implantable device programmer

N/A - 00763000273668

SW APP A71100 SCS RESTORE CLINICIAN
MEDTRONIC, INC.
A71100
In Commercial Distribution

  • 00763000273668 ()


  • Multiple active implantable device programmer

StealthStation Cranial Software - 00763000234867

SFW 9735762 APP STEALTH S8 APPLICATION
MEDTRONIC NAVIGATION, INC.
9735762
In Commercial Distribution

  • 00763000234867 ()


  • Multi-purpose stereotactic surgery system

FrameLink™ - 00721902966460

SFTWR 9731128 KIT, FRAMELINK APP -PLUS
MEDTRONIC NAVIGATION, INC.
9731128
In Commercial Distribution

  • 00721902966460 ()


  • Multi-purpose stereotactic surgery system

SonoNav™ - 00721902865565

SFTWR 9730780 KIT SONONAV APP - PLUS
MEDTRONIC NAVIGATION, INC.
9730780
In Commercial Distribution

  • 00721902865565 ()


  • Multi-purpose stereotactic surgery system

N/A - 00721902865558

SFTWR 9730897 KIT FUNCTIONAL APP - PLUS
MEDTRONIC NAVIGATION, INC.
9730897
In Commercial Distribution

  • 00721902865558 ()


  • Multi-purpose stereotactic surgery system

ClearLook Lighted Variety Pack with Rechargeable Light Source - 00714646001368

ClearLook Lighted Variety Pack with Rechargeable Light Source
Bionix, LLC
3645
In Commercial Distribution

  • 10714646001365 ()
  • 00714646001368 ()
3645

  • ENT illuminating foreign body extraction set

ClearLook Lighted InfantScoop, Refill - 00714646001351

ClearLook Lighted InfantScoop, 50ct Refill
Bionix, LLC
3460
In Commercial Distribution

  • 10714646001358 ()
  • 00714646001351 ()
3460

  • ENT illuminating foreign body extraction set

ClearLook Lighted Variety Pack, Refill - 00714646001344

ClearLook Lighted Variety Pack, 50ct Refill
Bionix, LLC
3445
In Commercial Distribution

  • 10714646001341 ()
  • 00714646001344 ()
3445

  • ENT illuminating foreign body extraction set

ClearLook Lighted FlexLoop, Refill - 00714646001337

ClearLook Lighted FlexLoop, 50ct Refill
Bionix, LLC
3440
In Commercial Distribution

  • 10714646001334 ()
  • 00714646001337 ()
3440

  • ENT illuminating foreign body extraction set

ClearLook Lighted VersaLoop, Refill - 00714646001320

ClearLook Lighted VersaLoop, 50ct Refill
Bionix, LLC
3430
In Commercial Distribution

  • 10714646001327 ()
  • 00714646001320 ()
3430

  • ENT illuminating foreign body extraction set

ClearLook Lighted MicroLoop, Refill - 00714646001313

ClearLook Lighted MicroLoop, 50ct Refill
Bionix, LLC
3420
In Commercial Distribution

  • 10714646001310 ()
  • 00714646001313 ()
3420

  • ENT illuminating foreign body extraction set

ClearLook Lighted AngleLoop, Refill - 00714646001306

ClearLook Lighted AngleLoop, 50ct Refill
Bionix, LLC
3410
In Commercial Distribution

  • 10714646001303 ()
  • 00714646001306 ()
3410

  • ENT illuminating foreign body extraction set

Lighted Articulating - Sample - 00714646001252

Lighted Articulating Curette - Sample
Bionix, LLC
22511
In Commercial Distribution

  • 00714646001252 ()
22511

  • ENT illuminating foreign body extraction set

ClearLook Lighted InfantScoop - 00714646001160

ClearLook Lighted InfantScoop, 50 curettes
Bionix, LLC
3360
In Commercial Distribution

  • 10714646001167 ()
  • 00714646001160 ()
3360

  • ENT illuminating foreign body extraction set

Clearlook Lighted Variety Pack - 00714646001153

Clearlook Lighted Variety Pack, 50 curettes
Bionix, LLC
3345
In Commercial Distribution

  • 10714646001150 ()
  • 00714646001153 ()
3345

  • ENT illuminating foreign body extraction set

ClearLook Lighted MicroLoop - 00714646001146

ClearLook Lighted MicroLoop, 50 curettes
Bionix, LLC
3320
In Commercial Distribution

  • 10714646001143 ()
  • 00714646001146 ()
3320

  • ENT illuminating foreign body extraction set

ClearLook Lighted AngleLoop - 00714646001139

ClearLook Lighted AngleLoop, 50 curettes
Bionix, LLC
3310
In Commercial Distribution

  • 10714646001136 ()
  • 00714646001139 ()
3310

  • ENT illuminating foreign body extraction set

ClearLook™ Sample Pack-Curettes & Light Source - 00714646000903

ClearLook™ Sample Pack-Curettes & Light Source
Bionix, LLC
23301
In Commercial Distribution

  • 00714646000903 ()
23301

  • ENT illuminating foreign body extraction set

ClearLook™ Sample Pack-Curettes Only - 00714646000897

ClearLook™ Sample Pack-Curettes Only
Bionix, LLC
23300
In Commercial Distribution

  • 00714646000897 ()
23300

  • ENT illuminating foreign body extraction set
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