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OtoNova Pro system for TEOAE, DPOAE and ABR hearing screening. Includes OtoNova Pro instrument, ear probe, system items, and DPTE+ABR Screener licence for the Nova-link app
OTODYNAMICS LIMITED
NPRO-SCR-DTA
In Commercial Distribution
- 05060396173165 ()
- Otoacoustic emission system, battery-powered
- Evoked-potential audiometer
EEG-based Neurofeedback Headset for use with the Axon mobile App, enabling users to modulate and redirect brain activity towards frequencies associated with relaxation and calm focused attention.
EXSURGO LIMITED
100500
In Commercial Distribution
- 09413000095982 ()
100500
- Psychophysiological biofeedback system
No Description
NT-Trading GmbH & Co. KG
UTG-2CON 80500A3S
Not in Commercial Distribution
- ENTTUTG2CON80500A3S1 ()
- 2-CONnect®-Abutment Set Ø 5,0 mm; gingiva height 2,5 mm; angled 20°; Compatible with implant system: Sweden & Martina Implantology™/ Premium TG® Implant
UTG-2CON 80500A3S
- Dental implant suprastructure, permanent, preformed
- Dental prosthesis/implant abutment screw
No Description
NT-Trading GmbH & Co. KG
UTG-2CON 80334A3M
Not in Commercial Distribution
- ENTTUTG2CON80334A3M1 ()
- 2-CONnect®-Abutment Ø 3,3 - 4,25 mm; gingiva height 2,5 mm; angled 20°;Compatible with implant system: Sweden & Martina Implantology™/ Premium TG® Implant
UTG-2CON 80334A3M
- Dental prosthesis/implant abutment screw
- Dental implant suprastructure, permanent, preformed
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.,.
Persona Medical
Evok 1600 Wireless
In Commercial Distribution
- 00851362008070 ()
- Air-conduction hearing aid, behind-the-ear
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.,.
Persona Medical
RxEars RX8
In Commercial Distribution
- 00851362008056 ()
- Air-conduction hearing aid, behind-the-ear
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.,.
Persona Medical
RxEars RX7
In Commercial Distribution
- 00851362008018 ()
- Air-conduction hearing aid, behind-the-ear
Cooling device using CO2 as coolant, powered by Li-Ion battery. Cooling plate 18", 1 temperature probe, 2 CO2 canisters 2.5lb/each, Bluetooth module to communicate with an App
FROSTIME LLC
V 1.0
In Commercial Distribution
- 00860003258415 ()
- Laboratory refrigerator/freezer
Cooling device using CO2 as coolant, powered by Li-Ion battery. Cooling plate 13", 1 temperature probe, 2 CO2 canisters 1lb/each, Bluetooth module to communicate with an App
FROSTIME LLC
V 1.0
In Commercial Distribution
- 00860003258408 ()
- Laboratory refrigerator/freezer
VALIDATE THY2 Calibration Verification / Linearity Test Kit solutions are intended for in vitro diagnostic use in the determination of linearity, calibration verification and verification of reportable range in automated instrument systems for the following analytes: Thyroglobulin (Tg).
Lgc Clinical Diagnostics, Inc.
908ro
In Commercial Distribution
- 00850011135600 ()
- Thyroglobulin IVD, control
No Description
NT-Trading GmbH & Co. KG
UTG-2CON 80334A3S
Not in Commercial Distribution
- ENTTUTG2CON80334A3S1 ()
- 2-CONnect®-Abutment Set Ø 3,3 - 4,25 mm; gingiva height 2,5 mm; angled 20°; Compatible with implant system: Sweden & Martina Implantology™/ Premium TG® Implant
UTG-2CON 80334A3S
- Dental prosthesis/implant abutment screw
- Dental implant suprastructure, permanent, preformed
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.
tyromotion GmbH
3
In Commercial Distribution
- 09120077180120 ()
- Biomechanical function analysis/rehabilitation software
No Description
Stockert GmbH
S7032
Not in Commercial Distribution
- 04260166370621 ()
https://gudid.fda.gov/gudid/app/admin/udi/recordDetails.xhtml#
- Percutaneous radio-frequency ablation system generator
25x2pcs
VISGENEER, INC.
30G I
In Commercial Distribution
- 04712558762342 ()
https://gudid.fda.gov/gudid/app/admin/udi/recordDetails.xhtml#
- Blood lancet, single-use
No Description
SIGNATURE ORTHOPAEDICS PTY LTD
111-12-9308
In Commercial Distribution
- 09348215045753 ()
https://gudid.fda.gov/gudid/app/admin/udi/recordDetails.xhtml#
- Non-constrained polyethylene acetabular liner
Extra-Wide, Adjustable Height Armboard (SWISS)
SCHUERCH CORPORATION
800-0017-SWISS
In Commercial Distribution
- 00810057373046 ()
https://gudid.fda.gov/gudid/app/admin/udi/recordDetails.xhtml#
- Arm procedure positioner, reusable
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.
Eko Devices, Inc.
Model E4
In Commercial Distribution
- 00863609000303 ()
- Electronic acoustic stethoscope
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.
Eko Devices, Inc.
E6
In Commercial Distribution
- 00850010298016 ()
- Electronic acoustic stethoscope
Calibra® Esthetic Resin Cement Veneer Kit
DENTSPLY INTERNATIONAL INC.
607200
Not in Commercial Distribution
- D0026072001 ()
- Weight: 2 Gram
- 5 Syringes Cement, 5 Syringes Try-In Paste, 1 Bottle Adhesive, 1 Dispensing Well, 50 Tips, 1 Light Protection Cover, 1 Syringe Silane Coupling Agent, 1 Syringe Tooth Cond Gel, 25 App Needles
- Weight: 1.8 Gram
607200
- Dental composite resin
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
Rice Lake Weighing Systems, Inc.
DHH-10BT
In Commercial Distribution
- 00850042373255 ()
201125
- Stand-on floor scale, electronic
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.
SECONDPERSPECTIVE LTD.
V2MDR-01
In Commercial Distribution
- 05070000320403 ()
- Tourniquet cuff, reusable
TPH®3 Easy-Twist Syringe Introductory Kit
DENTSPLY INTERNATIONAL INC.
642706
Not in Commercial Distribution
- D0026427061 ()
- Weight: 3 Gram
- Total Volume: 3 Milliliter
- 8 TPH3 Syringes, 5 P&B Unit Doses, 1 Prisma Gloss Fine and Extrafine Syringe, 1 syringe Tooth Cond Gel, 1 shade guide, 25 polishing cups, 1 mandrel, Enhance Discs, Cups, & Points, 5 App Tips
642706
- Dental composite resin
Cylindrical Implant - 3.75 X Length 11.5mm
Regular 2.42 Internal Hex
BHI IMPLANTS LTD
1
In Commercial Distribution
- 07290109745893 ()
- Outer Diameter: 3.75 Millimeter
- Length: 11.5 Millimeter
D-DFhttps://gudid.fda.gov/gudid/app/admin/udi/recordDetails.xhtml#3711
- Basket endosteal dental implant, two-piece
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.
Tatch Inc.
WSWW-RE-K-N-V01-GRD
In Commercial Distribution
- 00860007837012 ()
- Polysomnograph
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.
MedoPad Inc.
1.34
In Commercial Distribution
- G2871002 ()
1002
- Self-care monitoring/reporting software
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.
TherMidas Oy
Thermidas VistaClinic Analyzer
In Commercial Distribution
- 06429810718044 ()
ThAnalyzer
- Infrared thermography system
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
CALZIFICIO PINELLI SRL
057611
In Commercial Distribution
- 08300496057611 ()
048670
- Compression/pressure tubular garment
Esthet-X® HD High Definition Micro Matrix Restorative Total-Etch Direct Restorative Kit
DENTSPLY INTERNATIONAL INC.
630607
Not in Commercial Distribution
- D0026306071 ()
- Weight: 0.25 Gram
- 6 Compules® Tips, 1 Compules® Tips Gun, 3 Compula® Tips, Enhance® Finishers, 6 Bond Unit Doses, 1 Unit Dose Holder, 6 Flocked Applicator Tips, 1 Syringe Tooth Cond Gel, 25 App Tips
- Total Volume: 3 Milliliter
630607
- Dental composite resin
FluoroCore® 2+ Dual Cure Core Build-Up Material + Fast Endodontic Post Cement Introductory Kit
DENTSPLY INTERNATIONAL INC.
612400
Not in Commercial Distribution
- D0026124001 ()
- Weight: 4.75 Gram
- 2 Tooth Colored Syringes, 2 Blue Syringes, 1 bottle each Xeno®, P&B, and activator, 25 Mixing Tips, 25 Intraoral Tips, 10 Endo Intaoral Tips, 1 Disp Well, 50 App Tips, 50 Root Canal Tips
612400
- Dental composite resin
"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#
DiaDent Group International
ISO 45
In Commercial Distribution
- 08806383528894 ()
MP201-309
- Endodontic paper point