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Eko mobile app for android international platforms for use with Eko medical devices.
Eko Devices, Inc.
com.ekodevices.android.intl
In Commercial Distribution
- 00850010298061 ()
- Medical equipment clinical data interfacing software
DreamMapper Mobile Application Android (EMEA)
Respironics, Inc.
2.5
In Commercial Distribution
- 00606959042025 ()
1128265
- Self-care monitoring/reporting software
No Description
Infinitus Medical Technologies LLC
FPLS-3000
In Commercial Distribution
- 00860003986806 ()
FPLS-3000
- Operating table patient positioning set, single-use
No Description
FOURNITURES HOSPITALIERES INDUSTRIE
267363
In Commercial Distribution
- 03661489673634 ()
- Orthopaedic prosthesis implantation positioning instrument, reusable
No Description
BIOTRONIK SE & Co. KG
493241
In Commercial Distribution
- 04035479188733 ()
493241
- Implantable electrical stimulation device management software
No Description
BIOTRONIK SE & Co. KG
487878
In Commercial Distribution
- 04035479185817 ()
487878
- Implantable electrical stimulation device management software
No Description
NXSTAGE MEDICAL, INC.
NX1379
Not in Commercial Distribution
- M535NX1225NX1379 ()
- Medical equipment clinical data interfacing software
For the wireless mode version of the subject device, combined with an application installed on a tablet that can be used in a home environment, the content of the SPM01K4 convenience kit is:
1 electrostimulator SPM01M1 configuration;
electrodes;
protective skin, and
1 tablet with the MySPM@Home mobile application (SPM01A2).
NCS LAB SRL
SPM01K4
In Commercial Distribution
- 08051122040971 ()
SPM01K4
- Physical therapy transcutaneous neuromuscular electrical stimulation system
reSET-O® Mobile Application running on Android. reSET-O is intended to increase retention of patients with opioid use disorder (OUD) in outpatient treatment by providing cognitive behavioral therapy, as an adjunct to outpatient treatment that includes transmucosal buprenorphine and contingency management, for patients 18 years or older who are currently under the supervision of a clinician. reSET-O is indicated as a prescription-only digital therapeutic.
PEAR THERAPEUTICS, INC.
1
In Commercial Distribution
- 10851580008125 ()
- Mental health/function therapeutic software, screen-viewed
reSET-O® Mobile Application running on iOS. reSET-O is intended to increase retention of patients with opioid use disorder (OUD) in outpatient treatment by providing cognitive behavioral therapy, as an adjunct to outpatient treatment that includes transmucosal buprenorphine and contingency management, for patients 18 years or older who are currently under the supervision of a clinician. reSET-O is indicated as a prescription-only digital therapeutic.
PEAR THERAPEUTICS, INC.
1
In Commercial Distribution
- 10851580008118 ()
- Mental health/function therapeutic software, screen-viewed
reSET® Mobile Application running on Android. reSET is intended to provide cognitive behavioral therapy, as an adjunct to a contingency management system, for patients 18 years of age and older who are currently enrolled in outpatient treatment under the supervision of a clinician. reSET is indicated as a 12 week (90 days) prescription-only treatment for patients with substance use disorder (SUD), who are not currently on opioid replacement therapy, who do not abuse alcohol solely, or who do not abuse opioids as their primary substance of abuse. It is intended to:
- increase abstinence from a patient’s substances of abuse during treatment, and
- increase retention in the outpatient treatment program.
PEAR THERAPEUTICS, INC.
1
In Commercial Distribution
- 10851580008095 ()
- Mental health/function therapeutic software, screen-viewed
reSET® Mobile Application running on iOS. reSET is intended to provide cognitive behavioral therapy, as an adjunct to a contingency management system, for patients 18 years of age and older who are currently enrolled in outpatient treatment under the supervision of a clinician. reSET is indicated as a 12 week (90 days) prescription-only treatment for patients with substance use disorder (SUD), who are not currently on opioid replacement therapy, who do not abuse alcohol solely, or who do not abuse opioids as their primary substance of abuse. It is intended to:
- increase abstinence from a patient’s substances of abuse during treatment, and
- increase retention in the outpatient treatment program.
PEAR THERAPEUTICS, INC.
1
In Commercial Distribution
- 10851580008088 ()
- Mental health/function therapeutic software, screen-viewed
DreamMapper Android APAC Instance v 2.13
Respironics, Inc.
2.13
In Commercial Distribution
- 00606959051317 ()
1127960
- Self-care monitoring/reporting software
DreamMapper Android EU Instance v 2.13
Respironics, Inc.
2.13
In Commercial Distribution
- 00606959051300 ()
1128265
- Self-care monitoring/reporting software
DreamMapper Android NA Instance v 2.13
Respironics, Inc.
2.13
In Commercial Distribution
- 00606959051294 ()
1101479
- Self-care monitoring/reporting software
DreamMapper Android APAC Instance v 2.11
Respironics, Inc.
2.11
In Commercial Distribution
- 00606959049918 ()
1127960
- Self-care monitoring/reporting software
DreamMapper Android EU Instance v 2.11
Respironics, Inc.
2.11
In Commercial Distribution
- 00606959049901 ()
1128265
- Self-care monitoring/reporting software
DreamMapper Android NA Instance v 2.11
Respironics, Inc.
2.11
In Commercial Distribution
- 00606959049895 ()
1101479
- Self-care monitoring/reporting software
DreamMapper Android APAC Instance v 2.10
Respironics, Inc.
2.10
In Commercial Distribution
- 00606959049079 ()
1127960
- Self-care monitoring/reporting software
DreamMapper Android EU Instance v 2.10
Respironics, Inc.
2.10
In Commercial Distribution
- 00606959049062 ()
1128265
- Self-care monitoring/reporting software
DreamMapper Android NA Instance v 2.10
Respironics, Inc.
2.10
In Commercial Distribution
- 00606959049055 ()
1101479
- Self-care monitoring/reporting software
App for controlling Biomeme Frankin three9 thermocycler when used with the Biomeme Real-Time RT-PCR SARS-CoV-2 Test
Biomeme, Inc.
2.3.5
In Commercial Distribution
- 00810096640130 ()
- SARS-CoV-2 nucleic acid IVD, kit, nucleic acid technique (NAT)
SFTWR MMT-6122 FOTA IOS V1.3.4
MEDTRONIC MINIMED, INC.
MMT-6122
In Commercial Distribution
- 00763000532178 ()
- Patient health record information system application software
SFTWR MMT-6121 FOTA ANDROID V1.3.4
MEDTRONIC MINIMED, INC.
MMT-6121
In Commercial Distribution
- 00763000532161 ()
- Patient health record information system 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-5502-01-300
Not in Commercial Distribution
- 00817491023612 ()
FG-5502-01-300
- Implantable glucose monitoring system
Eversense CGM Mobile Application (iOS) is a software application that runs on a mobile device (e.g., smartphone or tablet) and displays glucose data, trend information, and alerts.
SENSEONICS, INCORPORATED
FG-5501-01-300
Not in Commercial Distribution
- 00817491023605 ()
FG-5501-01-300
- Implantable glucose monitoring system
The Eversense NOW Remote Monitoring App is intended for home use. The mobile app is intended to be a secondary device used to remotely view an Eversense CGM System user’s glucose information. The secondary display is not a replacement for either real time continuous glucose monitoring using the Eversense CGM System’s primary display, or for home blood glucose monitoring. The Eversense NOW Remote Monitoring App is not intended to be used to make treatment decisions or therapy adjustments.
SENSEONICS, INCORPORATED
FG-5902-01-300
In Commercial Distribution
- 00817491023490 ()
FG-5902-01-300
- Implantable glucose monitoring system
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-5502-01-300
Not in Commercial Distribution
- 00817491022387 ()
FG-5502-01-300
- Implantable glucose monitoring system
Eversense CGM Mobile Application (iOS) is a software application that runs on a mobile device (e.g., smartphone or tablet) and displays glucose data, trend information, and alerts.
SENSEONICS, INCORPORATED
FG-5501-01-300
Not in Commercial Distribution
- 00817491022370 ()
FG-5501-01-300
- Implantable glucose monitoring system
Eversense CGM Mobile Application (Android) is a software application that runs on a mobile device (e.g., smartphone or tablet) and displays glucose data, trend information, and alerts.
SENSEONICS, INCORPORATED
FG-5600-01-300
Not in Commercial Distribution
- 00817491020826 ()
FG-5600-01-300
- Implantable glucose monitoring system
Eversense CGM Mobile Application (iOS) is a software application that runs on a mobile device (e.g., smartphone or tablet) and displays glucose data, trend information, and alerts.
SENSEONICS, INCORPORATED
FG-5500-01-300
Not in Commercial Distribution
- 00817491020819 ()
FG-5500-01-300
- Implantable glucose monitoring system
No Description
Dexcom, Inc.
SW14131
In Commercial Distribution
- 00386270004659 ()
- Percutaneous interstitial fluid glucose monitoring system, electrochemical
No Description
Dexcom, Inc.
SW14117
In Commercial Distribution
- 00386270004642 ()
- Percutaneous interstitial fluid glucose monitoring system, electrochemical
No Description
Dexcom, Inc.
SW14116
In Commercial Distribution
- 00386270004635 ()
- Percutaneous interstitial fluid glucose monitoring system, electrochemical
Canister for Collection, Decantation and Re-injection of Autologous Tissue
SHIPPERT MEDICAL TECHNOLOGIES, INC
Tissu-Trans MEGA 1500
Not in Commercial Distribution
- 00893398002271 ()
- cc
3-TT-MEGA 1500
- Surgical suction system collection container, single-use
Canister for Collection, Filtration and Re-injection of Autologous Tissue
SHIPPERT MEDICAL TECHNOLOGIES, INC
Tissu-Trans Filtron 2000cc
Not in Commercial Distribution
- 00893398002264 ()
- cc
3-TT-FILTRON 2000
- Surgical suction system collection container, single-use
Canister for Collection, Filtration and Re-injection of Autologous Tissue
SHIPPERT MEDICAL TECHNOLOGIES, INC
Tissu-Trans Filtron 1000cc
Not in Commercial Distribution
- 00893398002257 ()
- cc
3-TT-FILTRON 1000
- Surgical suction system collection container, single-use
Canister for Collection, Filtration and Re-injection of Autologous Tissue
SHIPPERT MEDICAL TECHNOLOGIES, INC
Tissu-Trans Filtron 500cc
Not in Commercial Distribution
- 00893398002240 ()
- cc
3-TT-FILTRON 500
- Surgical suction system collection container, single-use
Syringes for Collection, Decantation and Re-injection of Autologous Tissue
SHIPPERT MEDICAL TECHNOLOGIES, INC
Tissu-Trans Syringe Fill 360
Not in Commercial Distribution
- 00893398002233 ()
- cc
3-TT-SFILL 360
- Surgical suction system collection container, single-use
Canister for Collection, Filtration and Re-injection of Autologous Tissue
SHIPPERT MEDICAL TECHNOLOGIES, INC
Tissu-Trans Filtron 250cc
Not in Commercial Distribution
- 00893398002172 ()
- cc
3-TT-FILTRON 250
- Surgical suction system collection container, single-use
Canister for Collection, Filtration and Re-injection of Autologous Tissue
SHIPPERT MEDICAL TECHNOLOGIES, INC
Tissu-Trans Filtron 100cc
Not in Commercial Distribution
- 00893398002165 ()
- cc
3-TT-FILTRON 100
- Surgical suction system collection container, single-use
Smart Spirometer connected to an app available on a smart phone
MIR MEDICAL INTERNATIONAL RESEARCH SPA
MIR SPIROBANK SMART
In Commercial Distribution
- 08052990321759 ()
- Expiratory peak flow meter, digital
Smart Spirometer connected to an app available on a smart phone
MIR MEDICAL INTERNATIONAL RESEARCH SPA
mSpirometer
In Commercial Distribution
- 08052990321636 ()
- Expiratory peak flow meter, digital
Smart Spirometer connected to an app available on a smart phone
MIR MEDICAL INTERNATIONAL RESEARCH SPA
MIR SPIROBANK SMART
In Commercial Distribution
- 08052990321124 ()
911105
- Expiratory peak flow meter, digital
Air Innovations Top Fill Bluetooth Speaker with APP & Extension Nozzle - Black
GREAT INNOVATIONS, LLC
MH-906
In Commercial Distribution
- 00180104000813 ()
- Room humidifier
Air Innovations Top Fill Bluetooth Speaker with APP & Extension Nozzle - White
GREAT INNOVATIONS, LLC
MH-906
In Commercial Distribution
- 00180104000806 ()
- Room humidifier
Air Innovations Top Fill Bluetooth Speaker with APP & Extension Nozzle - Navy
GREAT INNOVATIONS, LLC
MH-906
In Commercial Distribution
- 00180104000790 ()
- Room humidifier
Air Innovations Top Fill Bluetooth Speaker with APP & Extension Nozzle - Red
GREAT INNOVATIONS, LLC
MH-906
In Commercial Distribution
- 00180104000783 ()
- Room humidifier
DRSHD 1080p System, Rev 7https://gudid.fda.gov/gudid/app/admin/udi/recordDetails.xhtml#
Nds Surgical Imaging LLC
DRSHD.7
Not in Commercial Distribution
- 00817613020000 ()
- Endoscopic video image processing unit
HD Rapid Simplified / 07 150grhttps://gudid.fda.gov/gudid/app/admin/udi/recordDetails.xhtml#
Vertex-Dental B.V.
HDARSP0700150
Not in Commercial Distribution
- 08719425505121 ()
- Dental appliance fabrication material, resin