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Hearing Device incorporating Bluetooth Low Energy protocol to be controlled with Persona APP for basic changes to frequency response of device, for example: volume, memory, bass, treble...etc.,.

Hearing Device incorporating Bluetooth Low Energy protocol to be controlled with RxEars APP for basic changes to frequency response of device, for example: volume, memory, bass, treble...etc.,.

Hearing Device incorporating Bluetooth Low Energy protocol to be controlled with RxEars APP for basic changes to frequency response of device, for example: volume, memory, bass, treble...etc.,.

ARYS pro is intended to track and organize patient health and activity information recorded by sensors on the paretic and healthy wrist and using a mobile app for visualization.

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25x2pcs

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Extra-Wide, Adjustable Height Armboard (SWISS)

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The Eko Core Electronic Stethoscope is a complete electronic stethoscope with digital & analog capabilities that wirelessly pairs to the free Eko Mobile App for recording, visualization, sharing, and annotation of sounds.

The Eko Core Electronic Stethoscope is a complete electronic stethoscope with digital & analog capabilities that wirelessly pairs to the free Eko Mobile App for recording, visualization, sharing, and annotation of sounds.

Calibra® Esthetic Resin Cement Veneer Kit

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Suji device for BFR training. Suji comprises of a BLE enable pump, compression bands and a mobile app. The compression bands are worn at the top of the limb to restrict blood flow during exercise.

Scale, Digital Home Health Model DHH-10BT 440lb (200kg) x0.2lb (0.1kg) 300mm (L) x 360mm (W) x 8mm (H) includes (2) AAA batteries, tempered glass Includes Bluetooth connectivity compatible with Apple Health and Google Health APP

Cylindrical Implant - 3.75 X Length 11.5mm Regular 2.42 Internal Hex

TPH®3 Easy-Twist Syringe Introductory Kit

Wesper Lab (“the device”) is a digital recording device designed to collect sleep data in adult patients as prescribed by a healthcare professional. Wesper Lab uses a set of rechargeable, multi-use, adhesive patches that record physiological parameters during sleep. The kit is coupled with a charging pad for recharging, and a pulse oximeter to collect information about pulse rate and oxygen desaturations. The device employs a mobile application (“the app”), which resides on the patient’s personal mobile device, relaying sleep data wirelessly to a secure remote storage location (“the cloud”) for subsequent analysis by a healthcare professional. The app has 3 Bluetooth Low-Energy (BLE) ports, each of which receives multiple physiological channels from the patient. The device’s BLE ports connect to the following: 1. Abdominal patch 2. Thoracic patch 3. Pulse oximeter Data from the patches are transmitted via BLE throughout the night to the app, which uploads the data to the cloud. The third BLE port on the app connects to an authorized FDA-cleared pulse oximeter.

The Huma platform is a modular Software as a Medical Device (SaMD) which may utilise compatible devices and software to obtain data collated via a mobile app or web app and delivered to the clinician via a web portal or web app where it may be viewed to drive clinical management. It is intended to be used for the physiological and non-physiological intermittent or spot-check monitoring of all condition patients in professional healthcare facilities, such as clinics, hospitals or skilled nursing facilities, or in the patient’s home setting. It is intended for the monitoring of patients by trained healthcare professionals. The Huma platform comprises a number of different modules and functionalities that can be selected by the customer for configuration of care plans which can be further personalised for the patients. Clinical information collected from these modules is displayed on a clinician web portal and patient app with the addition of flagging out of range datasets, trend visualisation, goal setting and communication channels between clinicians and patients.

Thermidas VistaClinic Analyzer is a software app for the analysis of images that have been captured with Thermidas IRT-384 Tablet. The tools include adjustment of color scale, use of regions of interest, zoom & pan, and annotations.

LEGGINGS MAMAN 70 OPAQUE, SIZE M, MOKA, GRADUATED COMPRESSION 12/15 mmHg OPAQUE LEGGINGS FOR EXPECTANT MOhttps://gudid.fda.gov/gudid/app/admin/udi/recordDetails.xhtml#THERS WITH A POUCH AND A SUPPORTING BAND SUITABLE FOR THE GROWING BELLY

Esthet-X® HD High Definition Micro Matrix Restorative Total-Etch Direct Restorative Kit

FluoroCore® 2+ Dual Cure Core Build-Up Material + Fast Endodontic Post Cement Introductory Kit

"An absorbent paper points is an endodontic paper point that is used during the endodontic therapy to dry, or remove any foreign materials from the root canal of a tooth." https://gudid.fda.gov/gudid/app/admin/udi/recordDetails.xhtml#

"An absorbent paper points is an endodontic paper point that is used during the endodontic therapy to dry, or remove any foreign materials from the root canal of a tooth." https://gudid.fda.gov/gudid/app/admin/udi/recordDetails.xhtml#

Handheld (Bluetooth Low Energy protocol) personal wireless microphone to help hear companions easier in noisy or challenging listening environments. Used with RX8 Hearing aid(s) and controlled with RxEars APP as well as controls on the unit itself.

Handheld (Bluetooth Low Energy protocol) personal wireless microphone to help hear companions easier in noisy or challenging listening environments. Used with Evok 1600 Hearing aid(s) and controlled with Persona APP as well as controls on the unit itself.

Hearing Device incorporating wireless protocol to be controlled with Persona APP for basic changes to frequency response of device, for example: volume, memory, bass, treble...etc.,. Also, pick up phone calls and connect to a remote microphone/audio peripherals.

Hearing Device incorporating wireless protocol to be controlled with Persona APP for basic changes to frequency response of device, for example: volume, memory, bass, treble...etc.,. Also, pick up phone calls and connect to a remote microphone/audio peripherals.

Hearing Device incorporating wireless protocol to be controlled with Persona APP for basic changes to frequency response of device, for example: volume, memory, bass, treble...etc.,. Also, pick up phone calls and connect to a remote microphone/audio peripherals.

Hearing Device incorporating wireless protocol to be controlled with Persona APP for basic changes to frequency response of device, for example: volume, memory, bass, treble...etc.,. Also, pick up phone calls and connect to a remote microphone/audio peripherals.

The INVU by Nuvo™ System is a safe, non-invasive wearable monitoring system that provides continuous passive monitoring of vital pregnancy data of the pregnant person and the fetus through the INVU™ App. The information it provides is: Fetal heart rate (FHR), Maternal heart rate (MHR), and Uterine Activity (UA). The INVU by Nuvo™ System (as a part of the INVU 3200 Family/Catalogue) includes a wearable sensory band NV-BTSH-3000 (INVU Sensor Band™) that connects wirelessly to the INVU™ App installed on the pregnant person’s mobile device. The system may include additional peripheral devices, such as a blood pressure measuring device, depending on the care plan prescribed by the pregnant person’s medical supervisor. The INVU™ App installed on the pregnant person’s smartphone can log the measured blood pressure. The monitored pregnancy data is displayed on the mobile device by the INVU™ App. The recorded monitored pregnancy data can also be viewed by an assigned medical supervisor (or by a remote monitoring medical service), using the INVU Pro™ web application.

Wesper Lab (“the device”) is a digital recording device designed to collect sleep data in adult patients as prescribed by a healthcare professional. Wesper Lab uses a set of multi-use, adhesive patches that record physiological parameters during sleep. The kit is coupled with a pulse oximeter to collect information about pulse rate and oxygen desaturations. The device employs a mobile application (“the app”), which resides on the patient’s personal mobile device, relaying sleep data wirelessly to a secure remote storage location (“the cloud”) for subsequent analysis by a healthcare professional. The app has 3 Bluetooth Low-Energy (BLE) ports, each of which receives multiple physiological channels from the patient. The device’s BLE ports connect to the following: 1. Abdominal patch 2. Thoracic patch 3. Pulse oximeter Data from the patches are transmitted via BLE throughout the night to the app, which uploads the data to the cloud. The third BLE port on the app connects to an authorized FDA-cleared pulse oximeter. This Device Identification is for a kit that is shipped without a charger.

Hearing Device incorporating wireless protocol to be controlled with RxEars Pro APP for basic changes to frequency response of device, for example: volume, memory, bass, treble...etc.,. Also, pick up phone calls and connect to a remote microphone/audio peripherals.

Hearing Device (RIC) incorporating wireless protocol to be controlled with RxEars Pro APP for basic changes to frequency response of device, for example: volume, memory, bass, treble...etc.,. Also, pick up phone calls and connect to a remote microphone/audio peripherals.

Hearing Device (RIC) incorporating wireless protocol to be controlled with RxEars Pro APP for basic changes to frequency response of device, for example: volume, memory, bass, treble...etc.,. Also, pick up phone calls and connect to a remote microphone/audio peripherals.