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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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Sanibel Supply - 05711117126013

Medical device accessories intended for ABR measurements
Interacoustics A/S
Infant EarCup w/ Snap Electrodes
In Commercial Distribution

  • 05711117126013 ()
  • 05711117230062 ()
8049700

  • Evoked-potential audiometer

Sanibel Supply - 05711117126006

Medical device accessories intended for ABR measurements
Interacoustics A/S
Infant EarCup w/Tab electrodes
In Commercial Distribution

  • 05711117126006 ()
  • 05711117230055 ()
8049600

  • Evoked-potential audiometer

Sanibel Supply A/S - 05711117121742

Accessory for Real Ear Measurement (REM)
Interacoustics A/S
REM Probe tubes
In Commercial Distribution

  • 05711117226478 ()
  • 05711117121742 ()
8104116 (50 pcs)

  • Audiometric/hearing aid tester

Sanibel Supply A/S - 05711117094206

Accessory for Real Ear Measurement (REM), orange
Interacoustics A/S
REM Probe tubes
In Commercial Distribution

  • 05711117094206 ()
  • 05711117226485 ()
8500360 (40 pcs)

  • Audiometric/hearing aid tester

Gentuity HF-OCT Imaging System - 00859910007032

Gentuity OCT imaging console, including optical engine, PC, PIM with umbilical, 2 monitors (one with touch screen) and keyboard/mouse.
GENTUITY LLC
Gentuity Imaging System G10-01 K192922
In Commercial Distribution

  • 00859910007032 ()


  • Coronary optical coherence tomography system

Mediworks - 06945087505175

No Description
SHANGHAI MEDIWORKS PRECISION INSTRUMENTS CO.,LTD.
Scansys TA517
In Commercial Distribution

  • 06945087505175 ()


  • Eye anterior segment analyser

EGG-AF - 00860011843603

Tempus ECG-AF is a cardiovascular machine learning-based notification software intended to analyze recordings of 12-lead ECG devices from patients 65 years of age and older. The software employs machine learning techniques to analyze ECG recordings and detect signs associated with a patient experiencing atrial fibrillation and/or atrial flutter (collectively referred to as AF) within the next 12 months. The device is designed to extract otherwise unavailable information from ECGs conducted under the standard of care, to help health care providers better identify patients who may be at risk for undiagnosed AF in order to evaluate them for referral of further diagnostic follow up and address the unmet need of reducing the number of undiagnosed AF patients.
Tempus AI, Inc.
3
In Commercial Distribution

  • 00860011843603 ()


  • Cardiopulmonary physiological parameter analysis software

Humero Tech - 00860010519912

The Humero Tech C1 HD is an updated version of the Humero Tech C1 to better withstand strength and conditioning activities in addition to rehabilitation. The C1 HD is a seated apparatus capable of completing a vast number of shoulder rehabilitation and strengthening exercises. This device has the capability to be utilized in low level rehabilitation and strengthening progressing to more functional and dynamic activities. The Humero Tech C1 HD has an intended us of assisting with improving the strength, active range of motion, and motor control of the postoperative status, or when a deficit in power is noted. The device collects data and tracks range of motion to evaluate progress over time.
Titin Km Biomedical Corp.
C1 HD
In Commercial Distribution

  • 00860010519912 ()
A2-0000

  • Virtual-display rehabilitation system, passive-support, upper-limb

Humero Tech - 00860010519905

The Humero Tech C1 has been developed as a solution for the current limitations with shoulder rehabilitation. The C1 is a seated apparatus capable of completing a vast number of shoulder rehabilitation and strengthening exercises. This device has the capability to be utilized in low level rehabilitation and strengthening progressing to more functional and dynamic activities. The Humero Tech C1 has an intended use of assisting with improving the strength, active range of motion, and motor control of the shoulder complex. Furthermore, the indications for use will be any individual suffering from a shoulder pathology, including postoperative status, or when a deficit in power is noted. The device collects data and tracks range of motion to evaluate progress over time.
Titin Km Biomedical Corp.
C1
In Commercial Distribution

  • 00860010519905 ()
A1-0000

  • Virtual-display rehabilitation system, passive-support, upper-limb

Stanza - 00860010446324

A self-guided digital Acceptance and Commitment Therapy, a form of Cognitive Behavioral Therapy intended for the treatment of fibromyalgia symptoms. It is used by the patient at home or any out of clinic setting to reinforce their skills in acceptance and commitment therapy.
Swing Therapeutics, Inc.
1.2
In Commercial Distribution

  • 00860010446324 ()


  • Mental health/function therapeutic software, screen-viewed
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