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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Perifit Kegel Exerciser with App
X6 INNOVATIONS
Pink
Not in Commercial Distribution

  • 03770014642004 ()


  • Pelvic floor muscle exerciser
Lingo Biosensor iOS App US
ABBOTT DIABETES CARE INC
78783-01
In Commercial Distribution

  • 00357599849009 ()
78783-01

  • Percutaneous interstitial-fluid glucose monitoring system, electrochemical
Lathbury cotton app 6" regular
Medicon eG. Chirurgiemechaniker-Genossenschaft
955.62.80
In Commercial Distribution

  • 04046826203399 ()
955.62.80

  • Surgical tamp, reusable
Lathbury cotton app 6" triang
Medicon eG. Chirurgiemechaniker-Genossenschaft
955.62.20
In Commercial Distribution

  • 04046826203375 ()
955.62.20

  • Surgical tamp, reusable
Lathbury cotton app 6" triang
Medicon eG. Chirurgiemechaniker-Genossenschaft
955.62.00
In Commercial Distribution

  • 04046826203368 ()
955.62.00

  • Surgical tamp, reusable
BARANY Noise App. w. olive
Karl Storz GmbH & Co. KG
130000
In Commercial Distribution

  • 04048551054543 ()


  • Audiometric-evaluation noise system
Arial Web App Configured Tower.
Securitas Healthcare LLC
0850-173
In Commercial Distribution

  • 00840948103018 ()
0850-173

  • Desktop computer
ALLENTOWN LAP CHOLE APP PACK
Cardinal Health 200, LLC
SBA11LLSLF
In Commercial Distribution

  • 50197106899883 ()
  • 10197106899885 ()
SBA11LLSLF

  • Laparoscopic surgical procedure kit, non-medicated, single-use
Perifit Kegel Exerciser with App
X6 INNOVATIONS
Pink Perifit
Not in Commercial Distribution

  • 07109615470598 ()


  • Pelvic floor muscle exerciser
ALLENTOWN LAP CHOLE APP PACK
Cardinal Health 200, LLC
SBA11LLSL6
In Commercial Distribution

  • 50197106036479 ()
  • 10197106036471 ()
SBA11LLSL6

  • Laparoscopic surgical procedure kit, non-medicated, single-use
ALLENTOWN LAP CHOLE APP PACK
Cardinal Health 200, LLC
SBA11LLSL4
In Commercial Distribution

  • 50195594797131 ()
  • 10195594797133 ()
SBA11LLSL4

  • Laparoscopic surgical procedure kit, non-medicated, single-use
ALLENTOWN LAP CHOLE APP PACK
Cardinal Health 200, LLC
SBA11LLSL5
In Commercial Distribution

  • 50195594880147 ()
  • 10195594880149 ()
SBA11LLSL5

  • Laparoscopic surgical procedure kit, non-medicated, single-use
ALLENTOWN LAP CHOLE APP PACK
Cardinal Health 200, LLC
SBA11LLSLE
In Commercial Distribution

  • 50197106767748 ()
  • 10197106767740 ()
SBA11LLSLE

  • Laparoscopic surgical procedure kit, non-medicated, single-use
ALLENTOWN LAP CHOLE APP PACK
Cardinal Health 200, LLC
SBA11LLSLD
In Commercial Distribution

  • 50197106436514 ()
  • 10197106436516 ()
SBA11LLSLD

  • Laparoscopic surgical procedure kit, non-medicated, single-use
SW APP A710 SCS CLINICIAN
MEDTRONIC, INC.
A710
In Commercial Distribution

  • 00763000520076 ()


  • Multiple active implantable device programmer
SW APP A620 DBS PATIENT
MEDTRONIC, INC.
A620
In Commercial Distribution

  • 00763000041618 ()


  • Multiple active implantable device programmer
SW APP A90300 RECHAGER APPLICATION
MEDTRONIC, INC.
A90300
In Commercial Distribution

  • 00763000275655 ()


  • Multiple active implantable device programmer
ALLENTOWN LAP CHOLE APP PACK
Cardinal Health 200, LLC
SBA11LLSLB
In Commercial Distribution

  • 50195594959188 ()
  • 10195594959180 ()
SBA11LLSLB

  • Laparoscopic surgical procedure kit, non-medicated, single-use
ALLENTOWN LAP CHOLE APP PACK
Cardinal Health 200, LLC
SBA11LLSL3
In Commercial Distribution

  • 50195594700971 ()
  • 10195594700973 ()
SBA11LLSL3

  • Laparoscopic surgical procedure kit, non-medicated, single-use
MY TSF HOMECARE APP ANDROID
Smith & Nephew, Inc.
71075403
In Commercial Distribution

  • 00885556808016 ()
71075403

  • Wireless patient monitor/sensor reporting software, layperson-use
ALLENTOWN LAP CHOLE APP PACK
Cardinal Health 200, LLC
SBA11LLSLC
In Commercial Distribution

  • 50195594541888 ()
  • 10195594541880 ()
SBA11LLSLC

  • Laparoscopic surgical procedure kit, non-medicated, single-use
MY TSF HOMECARE APP iOS
Smith & Nephew, Inc.
71075402
In Commercial Distribution

  • 00885556746387 ()
71075402

  • Wireless patient monitor/sensor reporting software, layperson-use
SFTWR 9730896 CRANIAL APP - PLUS
MEDTRONIC NAVIGATION, INC.
9730896
In Commercial Distribution

  • 00721902865572 ()


  • Multi-purpose stereotactic surgery system
IOS & Android based APP used to control Evok 1600 OTE/BTE device.
Persona Medical
Persona APP
In Commercial Distribution

  • 00851362008087 ()


  • Air-conduction hearing aid, behind-the-ear
IOS & Android based APP used to control RxEars RX7 BTE device.
Persona Medical
RxEars APP
In Commercial Distribution

  • 00851362008025 ()


  • Air-conduction hearing aid, behind-the-ear
No Description
Clarius Mobile Health Corp
App - Android
In Commercial Distribution

  • 07540205000403 ()
12-01-00004

  • Ultrasound imaging system application software
  • Radiological PACS software
No Description
Clarius Mobile Health Corp
App - iOS
In Commercial Distribution

  • 07540205000397 ()
12-01-00003

  • Ultrasound imaging system application software
  • Radiological PACS software
Mobile version
3DIEMME SRL
RealGUIDE APP
In Commercial Distribution

  • 08050038830003 ()


  • CAD/CAM software
No Description
Pjama AB
DryGuardians App
In Commercial Distribution

  • 07350078445160 ()
4200

  • Incontinence sensor/alarm
OXIMETER,PULSE,FINGER,BLUETOOTH WITH APP
MEDLINE INDUSTRIES, INC.
HCSM70T
In Commercial Distribution

  • 00193489094261 ()
HCSM70T

  • Vacuum suction regulator/regulation set, general-purpose
Cycle Tracking iPhone App (Version 4.0)
APPLE INC.
Feature Version 4.x
In Commercial Distribution

  • 00194253312529 ()


  • Menstrual cycle self-monitoring software
Cycle Tracking Watch App (Version 4.0)
APPLE INC.
Feature Version 4.x
In Commercial Distribution

  • 00194253312512 ()


  • Menstrual cycle self-monitoring software
Cycle Tracking iPhone App (Version 3.0)
APPLE INC.
Feature Version 3.x
In Commercial Distribution

  • 00194252845974 ()


  • Menstrual cycle self-monitoring software
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 Watch app
APPLE INC.
Feature version 1.x
In Commercial Distribution

  • 00194252456804 ()


  • Self-care monitoring/reporting software
Atrial Fibrillation History Feature iPhone app
APPLE INC.
Feature version 1.x
In Commercial Distribution

  • 00194252456798 ()


  • Self-care monitoring/reporting software
Cochlear Baha Control App for Android
Cochlear Bone Anchored Solutions AB
95460
In Commercial Distribution

  • 09321502036399 ()
95460

  • Hearing aid/implant system remote control
Cochlear Baha Control App for iOS
Cochlear Bone Anchored Solutions AB
95459
In Commercial Distribution

  • 09321502036382 ()
95459

  • Hearing aid/implant system remote control
IV START KIT W/CHLORAPREP APP
MEDLINE INDUSTRIES, INC.
DYNDV2325
In Commercial Distribution

  • 20193489194811 ()
  • 10193489194814 ()
DYNDV2325

  • Peripheral intravenous catheterization support kit
MAJ-1352 BALLOON APP. FOR EBUS BRONCHSCP
OLYMPUS MEDICAL SYSTEMS CORP.
MAJ-1352
In Commercial Distribution

  • 04953170355981 ()


  • Surgical instrument assist arm system, manually-adjusted
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