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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Diabetes Management Software
ASCENSIA DIABETES CARE US INC.
3536
In Commercial Distribution

  • 00301933536018 ()
85498770

  • Self-care monitoring/reporting software
The SEER 1000 Apple App is a software product which is an accessory to the SEER 1000 recorder. The SEER 1000 Apple App assists in the hook-up procedure (e.g. displaying of ECG data and setting of patient demographic data).
getemed Medizin- und Informationstechnik AG
V1.2.1
In Commercial Distribution

  • 04250903201202 ()
2067634-056

  • Electrocardiographic ambulatory recorder
The SEER 1000 PC App is a software product which is an accessory to the SEER 1000 recorder. The SEER 1000 PC App assists in the hook-up procedure (e.g. displaying of ECG data and setting of patient demographic data).
getemed Medizin- und Informationstechnik AG
V1.0SP03
In Commercial Distribution

  • 04250903201196 ()
2067634-055

  • Electrocardiographic ambulatory recorder
Babysat System Application.
Owlet Baby Care, Inc.
2.23.0
In Commercial Distribution

  • 00810099090079 ()


  • Multiple vital physiological parameter monitoring system, home-use
Mobile App utilized in the PDM (Personal Device Manager) for Dash. Insulin pump secondary display. PDM Device 18239; app 41253
Insulet Corporation
1.3.1
In Commercial Distribution

  • 10385081120272 ()
18239

  • Ambulatory insulin infusion pump software, data-display
Mobile App utilized in the PDM (Personal Device Manager) for Dash Insulin pump secondary display. PDM Device 18239; app 41252
Insulet Corporation
1.3.1
In Commercial Distribution

  • 10385081120265 ()
18239

  • Ambulatory insulin infusion pump software, data-display
Hearing Implant Software for Android Devices
COCHLEAR LIMITED
P1860864
In Commercial Distribution

  • 09321502065757 ()
P2006652

  • Audiometric/hearing device software
For Insertable Cardiac Monitor
BOSTON SCIENTIFIC CORPORATION
622929-120
Not in Commercial Distribution

  • 00802526623110 ()
2929

  • Implantable cardiac device management application software
for Insertable Cardiac Monitor
BOSTON SCIENTIFIC CORPORATION
622939-120
Not in Commercial Distribution

  • 00802526623103 ()
2939

  • Implantable cardiac device management application software
for Insertable Cardiac Monitor
BOSTON SCIENTIFIC CORPORATION
2939
In Commercial Distribution

  • 00802526618215 ()
2939

  • Implantable cardiac device management application software
For Insertable Cardiac Monitor
BOSTON SCIENTIFIC CORPORATION
2929
In Commercial Distribution

  • 00802526618208 ()
2929

  • Implantable cardiac device management application software
for Insertable Cardiac Monitor
BOSTON SCIENTIFIC CORPORATION
622925-100
In Commercial Distribution

  • 00802526607608 ()
622925-100

  • Implantable cardiac device management application software
Eversense CGM Mobile Application (Android) is a software application that runs on a mobile device (e.g., smart phone or tablet) and displays glucose data, trend information, and alerts.
SENSEONICS, INCORPORATED
FG-5502-02-300
In Commercial Distribution

  • 00817491023537 ()
FG-5502-02-300

  • Implantable glucose monitoring system
Ovy by Beurer Basal Thermometer with Ovy App
BEURER NORTH AMERICA, L.P.
OT20
In Commercial Distribution

  • 20850003500434 ()
  • 10850003500437 ()
  • 00850003500430 ()
790.70

  • Thermometric fertility analyser
Hygieia d-Nav System Phone App - Android Operating System
HYGIEIA, INC.
V1m00b053d
In Commercial Distribution

  • 00860001044218 ()


  • Calculator, programmable
Irregular Rhythm Notification feature iPhone App (Version 2.0)
APPLE INC.
Feature Version 2.x
In Commercial Distribution

  • 00194252456781 ()


  • Self-care monitoring/reporting software
Irregular Rhythm Notification feature Watch App (Version 2.0)
APPLE INC.
Feature Version 2.x
In Commercial Distribution

  • 00194252456774 ()


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

  • 00606959054233 ()
1128265

  • Self-care monitoring/reporting software
ASSURE patient app is a component of CareStation.
Kestra Medical Technologies, Inc.
80601-001
In Commercial Distribution

80601-001

  • Medical equipment clinical data interfacing software
ASSURE patient app is a component of CareStation.
Kestra Medical Technologies, Inc.
80429-003
In Commercial Distribution

80429-003

  • Medical equipment clinical data interfacing software
DS Panacea APP Adj Pump & Deluxe Single Pad
COMPASS HEALTH BRANDS CORP.
DS-APP1-SYS
In Commercial Distribution

  • 30092237623825 ()
  • 00092237623824 ()


  • Alternating-pressure bed mattress overlay system
Lathbury cotton app 6" serr tip l/m
Medicon eG. Chirurgiemechaniker-Genossenschaft
955.62.60
In Commercial Distribution

  • 04046826203382 ()
955.62.60

  • Surgical tamp, reusable
WIRE SPEC TEMP APP NASAL SD 2 INCHES
SKLAR CORPORATION
22-8824
In Commercial Distribution

  • 10649111346149 ()


  • Eyelid speculum, reusable
SW APP A71400 SCS CLINICIAN CP NG RC
MEDTRONIC, INC.
A71400
In Commercial Distribution

  • 00763000371463 ()


  • Multiple active implantable device programmer
SW APP A72400 SCS CLINICIAN PP NG RC
MEDTRONIC, INC.
A72400
In Commercial Distribution

  • 00763000371470 ()


  • Multiple active implantable device programmer
SW APP A72200 SCS PATIENT NG PAIN PC
MEDTRONIC, INC.
A72200
In Commercial Distribution

  • 00763000287290 ()


  • Multiple active implantable device programmer
SW APP A52200 GU PATIENT MICRO EU MDR
MEDTRONIC, INC.
A52200
In Commercial Distribution

  • 00763000970079 ()


  • Multiple active implantable device programmer
SW APP A51200 GU CLINICIAN MICRO EU MDR
MEDTRONIC, INC.
A51200
In Commercial Distribution

  • 00763000970062 ()


  • Multiple active implantable device programmer
SW APP A820 TDD PATIENT PROG V2.X
MEDTRONIC, INC.
A820
In Commercial Distribution

  • 00763000632793 ()


  • Infusion pump programmer
SW APP A810 TDD CLINICIAN PROG V2.X
MEDTRONIC, INC.
A810
In Commercial Distribution

  • 00763000632786 ()


  • Infusion pump programmer
SW APP A71200 SCS CLINICIAN NG PAIN PC
MEDTRONIC, INC.
A71200
In Commercial Distribution

  • 00763000520083 ()


  • Multiple active implantable device programmer
Anterior Cervical Discectomy Fusion Titanium Cage L15 x W18 x H5 x A7
DIOMEDICAL CO.,LTD.
A
In Commercial Distribution

  • 08800039802598 ()

  • Height: 5 Millimeter
TAC.15180705

  • Metallic spinal fusion cage, non-sterile
Anterior Cervical Discectomy Fusion Titanium Cage L15 x W18 x H5 x A0
DIOMEDICAL CO.,LTD.
A
In Commercial Distribution

  • 08800039802512 ()

  • Height: 5 Millimeter
TAC.15180005

  • Metallic spinal fusion cage, non-sterile
Anterior Cervical Discectomy Fusion Titanium Cage L14 x W16 x H5 x A0
DIOMEDICAL CO.,LTD.
A
In Commercial Distribution

  • 08800039802413 ()

  • Height: 5 Millimeter
TAC.14160005

  • Metallic spinal fusion cage, non-sterile
Anterior Cervical Discectomy Fusion Titanium Cage L11 x W12 x H5 x A7
DIOMEDICAL CO.,LTD.
A
In Commercial Distribution

  • 08800039802239 ()

  • Height: 5 Millimeter
TAC.11120705

  • Metallic spinal fusion cage, non-sterile
Anterior Cervical Discectomy Fusion Titanium Cage L11 x W12 x H5 x A0
DIOMEDICAL CO.,LTD.
A
In Commercial Distribution

  • 08800039802154 ()

  • Height: 5 Millimeter
TAC.11120005

  • Metallic spinal fusion cage, non-sterile
Anterior Cervical Discectomy Fusion Titanium Cage L12 x W14 x H5 x A0
DIOMEDICAL CO.,LTD.
A
In Commercial Distribution

  • 08800039802314 ()

  • Height: 5 Millimeter
TAC.12140005

  • Metallic spinal fusion cage, non-sterile
Anterior Cervical Discectomy Fusion Titanium Cage L14 x W16 x H5 x A7
DIOMEDICAL CO.,LTD.
A
In Commercial Distribution

  • 08809557208752 ()

  • Height: 5 Millimeter
TAC.14160705

  • Metallic spinal fusion cage, non-sterile
Anterior Cervical Discectomy Fusion Titanium Cage L12 x W14 x H5 x A7
DIOMEDICAL CO.,LTD.
A
In Commercial Distribution

  • 08809557208691 ()

  • Height: 5 Millimeter
TAC.12140705

  • Metallic spinal fusion cage, non-sterile
Anterior Cervical Discectomy Fusion Cage (Flat) L15 x W18 x H5 x A7
DIOMEDICAL CO.,LTD.
A
In Commercial Distribution

  • 08809557207793 ()
ACF.15180705

  • Bone-screw internal spinal fixation system, non-sterile
Anterior Cervical Discectomy Fusion Cage (Flat) L15 x W18 x H5 x A0
DIOMEDICAL CO.,LTD.
A
In Commercial Distribution

  • 08809557207717 ()
ACF.15180005

  • Bone-screw internal spinal fixation system, non-sterile
Anterior Cervical Discectomy Fusion Cage (Flat) L14 x W16 x H5 x A7
DIOMEDICAL CO.,LTD.
A
In Commercial Distribution

  • 08809557207632 ()
ACF.14160705

  • Bone-screw internal spinal fixation system, non-sterile
Anterior Cervical Discectomy Fusion Cage (Flat) L14 x W16 x H5 x A0
DIOMEDICAL CO.,LTD.
A
In Commercial Distribution

  • 08809557207557 ()
ACF.14160005

  • Bone-screw internal spinal fixation system, non-sterile
Anterior Cervical Discectomy Fusion Cage (Flat) L12 x W14 x H5 x A7
DIOMEDICAL CO.,LTD.
A
In Commercial Distribution

  • 08809557207472 ()
ACF.12140705

  • Bone-screw internal spinal fixation system, non-sterile
Anterior Cervical Discectomy Fusion Cage (Flat) L12 x W14 x H5 x A0
DIOMEDICAL CO.,LTD.
A
In Commercial Distribution

  • 08809557207397 ()
ACF.12140005

  • Bone-screw internal spinal fixation system, non-sterile
Anterior Cervical Discectomy Fusion Cage (Flat) L11 x W12 x H5 x A7
DIOMEDICAL CO.,LTD.
A
In Commercial Distribution

  • 08809557207311 ()
ACF.11120705

  • Bone-screw internal spinal fixation system, non-sterile
Anterior Cervical Discectomy Fusion Cage (Flat) L11 x W12 x H5 x A0
DIOMEDICAL CO.,LTD.
A
In Commercial Distribution

  • 08809557207236 ()
ACF.11120005

  • Bone-screw internal spinal fixation system, non-sterile
Stethee Pro Mobile iOS Application is a component of the Stethee Pro Software System. The Stethee Pro Software System is intended for use with the Stethee Pro Electronic Stethoscope.
M3DICINE PTY LTD
2.0.X
In Commercial Distribution

  • 09351356000048 ()


  • Phonocardiograph
  • Stethoscope application software
No Description
IMPLANT DIRECT SYBRON MANUFACTURING LLC
DA-IOSDriver
In Commercial Distribution

  • 10841307128205 ()
DA-IOSDriver

  • Surgical screwdriver, reusable
Eversense 365 Mobile Application for iOS is a software application that runs on a mobile device (e.g., smart phone or tablet) and displays glucose data, trend information, and alerts.
SENSEONICS, INCORPORATED
FG-5503-06-300
In Commercial Distribution

  • 00817491024268 ()
FG-5503-06-300

  • Implantable glucose monitoring system
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