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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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MEDLINE - 10653160360469

IV START KIT W/CHLORAPREP APP
MEDLINE INDUSTRIES, INC.
DYNDV2591
In Commercial Distribution

  • 00653160360462 ()
  • 10653160360469 ()
DYNDV2591

  • Peripheral intravenous catheterization support kit

FreeStyle Libre 3 App - 00357599816001

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 - 00357599809003

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

Medline - 00193489094261

OXIMETER,PULSE,FINGER,BLUETOOTH WITH APP
MEDLINE INDUSTRIES, INC.
HCSM70T
In Commercial Distribution

  • 00193489094261 ()
HCSM70T

  • Vacuum suction regulator/regulation set, general-purpose

Medline - 10080196669943

PAD,REPLACEMENT,APP,W/FLAPS,AIRONE
MEDLINE INDUSTRIES, INC.
MSC80710
In Commercial Distribution

  • 10080196669943 ()
MSC80710

  • Alternating-pressure inflator

Medline Industries, Inc. - 10080196992980

IV START KIT W/CHLORAPREP APP
MEDLINE INDUSTRIES, INC.
DYND74260
In Commercial Distribution

  • 10080196992980 ()
  • 40080196992981 ()
DYND74260

  • General surgical procedure kit, non-medicated, single-use

Cycle Tracking 4.0 - 00194253312529

Cycle Tracking iPhone App (Version 4.0)
APPLE INC.
Feature Version 4.x
In Commercial Distribution

  • 00194253312529 ()


  • Menstrual cycle self-monitoring software

Cycle Tracking 4.0 - 00194253312512

Cycle Tracking Watch App (Version 4.0)
APPLE INC.
Feature Version 4.x
In Commercial Distribution

  • 00194253312512 ()


  • Menstrual cycle self-monitoring software

Cycle Tracking 3.0 - 00194252845974

Cycle Tracking iPhone App (Version 3.0)
APPLE INC.
Feature Version 3.x
In Commercial Distribution

  • 00194252845974 ()


  • Menstrual cycle self-monitoring software

Cycle Tracking 3.0 - 00194252845967

Cycle Tracking Watch App (Version 3.0)
APPLE INC.
Feature Version 3.x
In Commercial Distribution

  • 00194252845967 ()


  • Menstrual cycle self-monitoring software

Atrial Fibrillation History Feature - 00194252456804

Atrial Fibrillation History Feature Watch app
APPLE INC.
Feature version 1.x
In Commercial Distribution

  • 00194252456804 ()


  • Self-care monitoring/reporting software

Atrial Fibrillation History Feature - 00194252456798

Atrial Fibrillation History Feature iPhone app
APPLE INC.
Feature version 1.x
In Commercial Distribution

  • 00194252456798 ()


  • Self-care monitoring/reporting software

Karl Schumacher - 00842517117266

Bone Graft App Plugger & Scoop, Z-Line
Karl Schumacher Dental, LLC
SPA1422
In Commercial Distribution

  • 00842517117266 ()


  • Periosteal elevator, reusable

Baha - 09321502036399

Cochlear Baha Control App for Android
Cochlear Bone Anchored Solutions AB
95460
In Commercial Distribution

  • 09321502036399 ()
95460

  • Hearing aid/implant system remote control

CARDINAL HEALTH - 10885425518302

STRL ALLENTWN LAP CHOLE APP PK
Cardinal Health 200, LLC
SLC11LLSLG
In Commercial Distribution

  • 50885425518300 ()
  • 10885425518302 ()
SLC11LLSLG

  • Laparoscopic surgical procedure kit, non-medicated, single-use

DIRECTVIEW CR Cassette with HR Screen - 40889971044613

18X24CM DRCTVIEW HR SP APP SCRN
CARESTREAM HEALTH, INC.
DIRECTVIEW CR Cassette with HR Screen
In Commercial Distribution

  • 60889971044617 ()
  • 40889971044613 ()
1044619

  • Digital imaging cassette/phosphor plate

CARESTREAM Image Suite - 60889971055989

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

  • 60889971055989 ()
1055987

  • Radiological PACS software

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 - 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 - 00763000910143

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

  • 00763000910143 ()


  • 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 - 00763000968168

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

  • 00763000968168 ()


  • Self-care monitoring/reporting software

Nalu Medical, Inc. - 00812537030470

SCS Remote App (compatible with Android)
NALU MEDICAL, INC.
53002-001
In Commercial Distribution

  • 00812537030470 ()
53002-001

  • Implantable electrical stimulation device management software

PILLING - 24026704507102

LARGE VESS APP 15MM TAPERED BLADES
TELEFLEX INCORPORATED
IPN002336
In Commercial Distribution

  • 04026704507108 ()
  • 24026704507102 ()

  • Length: 1.625 Inch
  • Width: 1 Inch
065196

  • Surgical bulldog clamp, reusable

StealthStation Cranial Software - 00763000368494

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

  • 00763000368494 ()


  • 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

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

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

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

Medtronic Navigation - 00763000456986

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

  • 00763000456986 ()


  • 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

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

N/A - 00763000612832

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

  • 00763000612832 ()


  • Multiple active implantable device programmer

StealthStation S8 - 00763000852818

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

  • 00763000852818 ()


  • Multi-purpose stereotactic surgery system

MiniMed™ Mobile - 00763000827786

SFTWR MMT-6101 AHCL 2.1.0 APP ANDROID
MEDTRONIC MINIMED, INC.
MMT-6101
In Commercial Distribution

  • 00763000827786 ()


  • Self-care monitoring/reporting software

StealthStation Cranial Software - 00763000234867

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

  • 00763000234867 ()


  • Multi-purpose stereotactic surgery system

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 - 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

StealthStation Cranial Software - 00763000125295

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

  • 00763000125295 ()


  • Multi-purpose stereotactic surgery system

Biodenta - 07640169731419

Scan Body with Screw Compatible with Osstem (Hiossen) TSIII Regular IOS
Biodenta Swiss AG
CAD-SBOTS45
In Commercial Distribution

  • 07640169731419 ()
CAD-SBOTS45

  • Dental implant abutment analog, intraoral-scanning, single-use

Biodenta - 07640169731402

Scan Body with Screw Compatible with Osstem (Hiossen) TSIII Mini IOS
Biodenta Swiss AG
CAD-SBOTS35
In Commercial Distribution

  • 07640169731402 ()
CAD-SBOTS35

  • Dental implant abutment analog, intraoral-scanning, single-use

Nobel Biocare N1™ - 07332747162905

Insertion Tool IOS Implant Replica Nobel Biocare N1™ NP/RP
Nobel Biocare AB
300966
In Commercial Distribution

  • 07332747162905 ()
300966

  • Dental implant suprastructure, temporary, preformed, reusable

Laryseal Blue Laryngeal Mask Airway Slimline Pack Size 2 - 05055788777694

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

SoNoNav® Calibration App - 00643169183407

SOFTWARE 9734472 SONONAV CAL APP FOR SC
MEDTRONIC NAVIGATION, INC.
9734472
In Commercial Distribution

  • 00643169183407 ()


  • Multi-purpose stereotactic surgery system
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