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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Hearing Implant Software for Android Devices
COCHLEAR LIMITED
P1860864
In Commercial Distribution

  • 09321502065757 ()
P2006652

  • Audiometric/hearing device 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
Rabbit antiserum, Ready to use
Ssi Diagnostica A/S
54402
In Commercial Distribution

  • 05713106544020 ()
54402

  • Escherichia coli antigen IVD, antibody
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 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 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 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 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
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
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
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
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
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 A72400 SCS CLINICIAN PP NG RC
MEDTRONIC, INC.
A72400
In Commercial Distribution

  • 00763000371470 ()


  • Multiple active implantable device programmer
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