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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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
DreamMapper Mobile Application Android (EMEA)
Respironics, Inc.
2.5
In Commercial Distribution

  • 00606959042025 ()
1128265

  • Self-care monitoring/reporting software
No Description
Dexcom, Inc.
SW14117
In Commercial Distribution

  • 00386270004642 ()


  • Percutaneous interstitial fluid glucose monitoring system, electrochemical
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
No Description
FOURNITURES HOSPITALIERES INDUSTRIE
267363
In Commercial Distribution

  • 03661489673634 ()


  • Orthopaedic prosthesis implantation positioning instrument, reusable
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® 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
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
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
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
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)
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
SFTWR MMT-6121 FOTA ANDROID V1.3.4
MEDTRONIC MINIMED, INC.
MMT-6121
In Commercial Distribution

  • 00763000532161 ()


  • Patient health record information system application software
No Description
Philips Ultrasound LLC
795160
In Commercial Distribution

  • 00884838103399 ()


  • Extracorporeal ultrasound imaging transducer, hand-held
Accessories
CeramTec Schweiz GmbH
301291
In Commercial Distribution

  • 07640161395015 ()
301291

  • Dental implant suprastructure, temporary, preformed, single-use
No Description
Zhejiang Shuyou Surgical Instrument Co.,Ltd.
VIX-A015腔镜电极
In Commercial Distribution

  • 06924274950608 ()


  • Open-surgery electrosurgical electrode, monopolar, single-use
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
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
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
Hoen Nerve Hook Straight 22cmhttps://gudid.fda.gov/gudid/app/admin/udi/recordDetails.xhtml#
KOROS U.S.A., INC.
7225-05
In Commercial Distribution

  • 00840199507528 ()
  • 10840199507525 ()

  • 9x12mm
7225-05

  • Soft-tissue surgical hook, reusable
GAS-ASSISTED SPRAY SET ENDOSCOPIC APP. 5MM 30 CM, 1:1 RATIO
Micromedics, Inc.
SA-3654
In Commercial Distribution

  • 10815634020075 ()
  • 00815634020078 ()
  • 20815634020072 ()


  • Open-surgery adhesive/sealant applicator, dual-channel
6mm Kerrison Rongeur, 350mm https://gudid.fda.gov/gudid/app/admin/udi/recordDetails.xhtml#
Osseus Fusion Systems, LLC
1760-7070
In Commercial Distribution

  • B06217607070 ()
1760-7070

  • Spinal rongeur
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
Gastric Bypass Pack _Sterile_3EA/CShttps://gudid.fda.gov/gudid/app/admin/udi/recordDetails.xhtml#
GRI Medical & Electronic Technology Co., Ltd.
LGH011
In Commercial Distribution

  • 26931918174539 ()
  • 16931918174532 ()


  • General surgical procedure kit, non-medicated, single-use
M300 OvuCore Starter Pack - M026 OvuCore Vaginal Sensor and M032 OvuSense App
VIO HEALTHTECH LIMITED
M300
In Commercial Distribution

  • 05060508530039 ()


  • Thermometric fertility analyser
Ear thermometer with bluetooth which transmits data to app on mobile phone
Masena Invest B.V.
ET-624BT
In Commercial Distribution

  • 08719481720193 ()


  • Intermittent electronic patient thermometer
Robot Arm Interface instrument Rosa 3.0 instrument ROSA One spine app 3.1
MEDTECH
ROSA3-048A
Not in Commercial Distribution

  • 03760244030436 ()
ROSAS00126

  • Neurological stereotactic surgery system
  • Multi-purpose stereotactic surgery system
Pressure PreventionGroup 1 Surfaces Product Description: APP Pad Only, 1/ea, RTL
Drive Devilbiss Healthcare
14003
In Commercial Distribution

  • 50822383103742 ()
  • 00822383103747 ()


  • Alternating-pressure inflator
  • Alternating-pressure bed mattress overlay, reusable
  • Alternating-pressure bed mattress overlay system
RIGID ENDOSCOPIC AEROSOL APP. 5MM DIA X 40CM (16 IN) 1:1
Micromedics, Inc.
800-0217
In Commercial Distribution

  • 00815634020283 ()
  • 10815634020280 ()
  • 20815634020287 ()


  • Open-surgery adhesive/sealant applicator, dual-channel
The ZEISS® Connect App mobile application will be an optional accessory of ZEISS® UNO 3 microscope product. ZEISS® Connect application SW will be available to the end user as an iOS app and user should be able to download and install the same from Apple App store. ZEISS® Connect App will pair wirelessly to the UNO3 variants of microscope and associated peripheral devices (like monitor etc.). This database entry covers UDI for SW version 2.0 and higher. Version 2.0-> UDI - (01)04049539070135(10)200-> Version 3.0-> UDI - (01)04049539070135(10)301 ->Version 4.2-> UDI - (01)04049539070135(10)420
Carl Zeiss Meditec AG
2.0
In Commercial Distribution

  • 04049539070135 ()


  • Multidisciplinary medical image management software
The Wavely Middle Ear Fluid Scanner utilizes the WavelyDx Middle Ear Fluid CMD iOS Application, the mobile software, used in conjunction with the Wavely Ear Tip. The Wavely Middle Ear Fluid Scanner turns a smartphone into an acoustic reflectometer, which uses sound waves to accurately detect the presence of middle ear fluid that may be associated with acute ear infection.
Wavely Diagnostics, Inc.
SWA-1262
In Commercial Distribution

  • 00860007953712 ()
SWA-1262

  • Impedance audiometer
Accessories
CeramTec Schweiz GmbH
301251
In Commercial Distribution

  • 07640161394780 ()
301251

  • Dental implant suprastructure, temporary, preformed, single-use
Accessories
CeramTec Schweiz GmbH
301250
In Commercial Distribution

  • 07640161394773 ()
301250

  • Dental implant suprastructure, temporary, preformed, single-use
Accessories
CeramTec Schweiz GmbH
301249
In Commercial Distribution

  • 07640161394766 ()
301249

  • Dental implant suprastructure, temporary, preformed, single-use
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