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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Navina Smart Transanal Irrigation. Bowel diary APP
Wellspect AB
75751
In Commercial Distribution

75751

  • Rectal irrigation system application software
SW MMT-8061 INPEN 2.0 ANDROID APP US
MEDTRONIC MINIMED, INC.
MMT-8061
In Commercial Distribution

  • 00763000974596 ()


  • Empty self-injector, mechanical
A mobile app for HANSATON hearing instruments
Sonova AG
088-5018
In Commercial Distribution

  • 07613389610932 ()


  • Audiometric/hearing device software
Navina Smart Transanal Irrigation. Bowel diary APP
Wellspect AB
75751
Not in Commercial Distribution

  • 07392532242380 ()
75751

  • Rectal irrigation system application software
SFTWR CSS7201 GRDN MBL APP ANDRD V4.1.1
MEDTRONIC MINIMED, INC.
CSS7201
In Commercial Distribution

  • 00763000381097 ()


  • Patient health record information system application software
SW APP A71300 SCS CLINICIAN TRIALING 2.0
MEDTRONIC, INC.
A71300
In Commercial Distribution

  • 00763000533199 ()


  • Multiple active implantable device programmer
SW D00U027 SS LINQ II PLATFORM APP
MEDTRONIC, INC.
D00U027
In Commercial Distribution

  • 00763000891091 ()


  • Implantable cardiac device management application software
No Description
Boston Brace International, Inc.
SENSOR-MA-V1
In Commercial Distribution

  • 00860013109813 ()


  • Wireless patient monitor/sensor reporting software, layperson-use
The .decimal Astroid Dosimetry App device is used for planning and analysis of proton radiation therapy treatments.
DECIMAL, INC.
1.0
In Commercial Distribution

  • 00851147007076 ()


  • Radiation therapy software
Eko mobile app for Android platforms for use with Eko products.
Eko Devices, Inc.
1.2.9
In Commercial Distribution

  • 00863609000341 ()


  • Medical equipment clinical data interfacing software
No Description
NFANT LABS LLC
1
In Commercial Distribution

  • 00861410000246 ()
NA4

  • Biofeedback system application software
Diabetes Management Software
ASCENSIA DIABETES CARE US INC.
3537
In Commercial Distribution

  • 00301933537015 ()
85498754

  • Self-care monitoring/reporting software
Diabetes Management Software
ASCENSIA DIABETES CARE US INC.
3536
In Commercial Distribution

  • 00301933536018 ()
85498770

  • Self-care monitoring/reporting 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
For the wireless mode version of the subject device, to be used in combination with an application installed on a tablet, the SPM01K3 convenience kit includes: 1 electrostimulator SPM01M1 configuration; electrodes; protective skin, and 1 tablet with the MySPM mobile application (SPM01A1).
NCS LAB SRL
SPM01K3
In Commercial Distribution

  • 08051122040964 ()
SPM01K3

  • Physical therapy transcutaneous neuromuscular electrical stimulation system
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
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
for Android
COCHLEAR LIMITED
NSA-2 / v5
In Commercial Distribution

  • 09321502062190 ()
P1834165

  • Audiometric/hearing device software
for Android
COCHLEAR LIMITED
NSA-2 / v4
In Commercial Distribution

  • 09321502060479 ()
P1787373

  • Audiometric/hearing device software
Hearing Implant Software for Android Devices
COCHLEAR LIMITED
P1860864
In Commercial Distribution

  • 09321502065757 ()
P2006652

  • Audiometric/hearing device software
Accessory to ERT's Asthma Monitor device for professional users
eResearchTechnology GmbH
2.x
In Commercial Distribution

  • 04057155000603 ()


  • Expiratory peak flow meter, digital
No Description
CURBELL MEDICAL PRODUCTS, INC.
Rego Safe Mobility App
In Commercial Distribution

  • 00840828192095 ()


  • Inpatient motion surveillance software
Babysat System Application.
Owlet Baby Care, Inc.
2.23.0
In Commercial Distribution

  • 00810099090079 ()


  • Multiple vital physiological parameter monitoring system, home-use
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
Scan Body with Screw Compatible with Astra Tech OsseoSpeed 3.5/4.0 IOS
Biodenta Swiss AG
CAD-SBATOS3545
In Commercial Distribution

  • 07640169736346 ()
CAD-SBATOS3545

  • Dental implant abutment analog, intraoral-scanning, single-use
4.8mm Diameter, 6.5mm Platform TG Implant Length 14mm Sandblast Collar Height 2.8mm
TITAN IMPLANT INC
IS-48/6TG14S2
In Commercial Distribution

  • 00842448114457 ()


  • Dental implant system
4.8mm Diameter, 6.5mm Platform TG Implant Length 12mm Sandblast Collar Height 2.8mm
TITAN IMPLANT INC
IS-48/6TG12S2
In Commercial Distribution

  • 00842448114433 ()


  • Dental implant system
4.8mm Diameter, 6.5mm Platform TG Implant Length 10mm Sandblast Collar Height 2.8mm
TITAN IMPLANT INC
IS-48/6TG10S2
In Commercial Distribution

  • 00842448114419 ()


  • Dental implant system
4.8mm Diameter, 6.5mm Platform TG Implant Length 14mm RBM Collar Height 1.8mm
TITAN IMPLANT INC
IS-48/6TG14R1
In Commercial Distribution

  • 00842448114365 ()


  • Dental implant system
4.8mm Diameter, 4.8mm Platform TG Implant Length 14mm Sandblast Collar Height 2.8mm
TITAN IMPLANT INC
IS-48/4TG14S2
In Commercial Distribution

  • 00842448114310 ()


  • Dental implant system
4.8mm Diameter, 4.8mm Platform TG Implant Length 12mm Sandblast Collar Height 2.8mm
TITAN IMPLANT INC
IS-48/4TG12S2
In Commercial Distribution

  • 00842448114297 ()


  • Dental implant system
4.8mm Diameter, 4.8mm Platform TG Implant Length 10mm Sandblast Collar Height 2.8mm
TITAN IMPLANT INC
IS-48/4TG10S2
In Commercial Distribution

  • 00842448114273 ()


  • Dental implant system
4.8mm Diameter, 4.8mm Platform TG Implant Length 8mm Sandblast Collar Height 2.8mm
TITAN IMPLANT INC
IS-48/4TG8S2
In Commercial Distribution

  • 00842448114259 ()


  • Dental implant system
4.8mm Diameter, 4.8mm Platform TG Implant Length 14.0mm RBM Collar Height 1.8mm
TITAN IMPLANT INC
IS-48/4TG14R1
In Commercial Distribution

  • 00842448114228 ()


  • Dental implant system
4.8mm Diameter, 4.8mm Platform TG Implant Length 10.0mm Sandblast Collar Height 1.8mm
TITAN IMPLANT INC
IS-48/4TG10S1
In Commercial Distribution

  • 00842448114198 ()


  • Dental implant system
4.8mm Diameter, 4.8mm Platform TG Implant Length 10.0mm RBM Collar Height 1.8mm
TITAN IMPLANT INC
IS-48/4TG10R1
In Commercial Distribution

  • 00842448114181 ()


  • Dental implant system
4.8mm Diameter, 4.8mm Platform TG Implant Length 8mm RBM Collar Height 1.8mm
TITAN IMPLANT INC
IS-48/4TG8R1
In Commercial Distribution

  • 00842448114167 ()


  • Dental implant system
4.1mm Diameter, 4.8mm Platform TG Implant Length 14mm Sandblast Collar Height 2.8mm
TITAN IMPLANT INC
IS-41/4TG14S2
In Commercial Distribution

  • 00842448114150 ()


  • Dental implant system
4.1mm Diameter, 4.8mm Platform TG Implant Length 12mm Sandblast Collar Height 2.8mm
TITAN IMPLANT INC
IS-41/4TG12S2
In Commercial Distribution

  • 00842448114136 ()


  • Dental implant system
4.1mm Diameter, 4.8mm Platform TG Implant Length 10mm Sandblast Collar Height 2.8mm
TITAN IMPLANT INC
IS-41/4TG10S2
In Commercial Distribution

  • 00842448114112 ()


  • Dental implant system
4.1mm Diameter, 4.8mm Platform TG Implant Length 14mm RBM Collar Height 1.8mm
TITAN IMPLANT INC
IS-41/4TG14R1
In Commercial Distribution

  • 00842448114068 ()


  • Dental implant system
4.1mm Diameter, 4.8mm Platform TG Implant Length 12mm Sandblast Collar Height 1.8mm
TITAN IMPLANT INC
IS-41/4TG12S1
In Commercial Distribution

  • 00842448114051 ()


  • Dental implant system
4.1mm Diameter, 4.8mm Platform TG Implant Length 12mm RBM Collar Height 1.8mm
TITAN IMPLANT INC
IS-41/4TG12R1
In Commercial Distribution

  • 00842448114044 ()


  • Dental implant system
4.1mm Diameter, 4.8mm Platform TG Implant Length 10mm Sandblast Collar Height 1.8mm
TITAN IMPLANT INC
IS-41/4TG10S1
In Commercial Distribution

  • 00842448114037 ()


  • Dental implant system
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