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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RESET Mobile Application runs on iOS and is intended to provide cognitive behavioral therapy, as an adjunct to a contingency management system, for patients 18 years of age and older.
Harvest Bio LLC
2.0.2
In Commercial Distribution

  • 00850074433002 ()


  • Mental health/function therapeutic software, screen-viewed
Anasept Antimicrobial Skin and Wound cleanser filled in 8 oz. cone top, HDPE bottles with Trigger sprayer
ARGENTUM MEDICAL, LLC
4008TC
In Commercial Distribution

  • 10856040008424 ()
  • 00856040008427 ()


  • Antimicrobial wound irrigation solution
ANTI-TG IS AN ELISA TEST SYSTEM FOR THE QUANTITATIVE MEASUREMENT OF IgG CLASS AUTOANTIBODIES AGAINST THYROGLOBULIN (TG) IN HUMAN SERUM OR PLASMA. THIS PRODUCT IS INTENDED FOR PROFESSIONAL IN VITRO DIAGNOSTIC USE ONLY.
ORGENTEC Diagnostika GmbH
ORG502
Not in Commercial Distribution

  • 04260157080010 ()
ORG502

  • Thyroglobulin antibody IVD, kit, enzyme immunoassay (EIA)
SC TABLET MINI, SGD, WITH TDSNAP FOR iOS and iPad Mini. Small portable speech device for people who can not speak due to disability, injury or illness. High output speakers, durability and ingress protection for
TOBII DYNAVOX LLC
SC Tablet Mini
In Commercial Distribution

  • 07340074601929 ()
113527

  • Voice synthesizer/digitizer
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
Spaulding Client Application is a web based application for trained users of the Spaulding Medical Electrocardiograph device 2100iQ. The application enables clinicians or trained core personnel who are acting on the orders of a licensed physician to process, display, store, and print diagnostic 12 lead ECGs utilizing an IOS platform.
SPAULDING MEDICAL
1.3.6.1
In Commercial Distribution

  • B441SMIOSCLIENTAPP0 ()
SMIOSCLIENTAPP

  • Electrocardiographic long-term ambulatory recording analyser application software
iOS application portion for Salux™ Tablet-Controlled Audiometer system. The Examinetics Tablet-Controlled Audiometer is an audiometer designed to be compliant with ANSI Standard 3.6. The Salux™ Audiometer will have the ability to interface with other software necessary for administering hearing screenings. The Salux™ Audiometer solution can be used to display video or static content to the participant.
Examinetics, Inc.
SALUX-SW-02
In Commercial Distribution

SALUX-SW-02

  • Tone audiometer, semi-automated
iOS application portion for Salux™ Tablet-Controlled Audiometer system. The Examinetics Tablet-Controlled Audiometer is an audiometer designed to be compliant with ANSI Standard 3.6. The Salux™ Audiometer will have the ability to interface with other software necessary for administering hearing screenings. The Salux™ Audiometer solution can be used to display video or static content to the participant.
Examinetics, Inc.
SALUX-SW-01
In Commercial Distribution

  • 00860007826627 ()
SALUX-SW-01

  • Tone audiometer, semi-automated
Standard Imaging Stereotactic Dose Verification Phantom can be used for a wide variety of tests including routine absolute dosimetry output checks and treatment planning system(TPS) commissioning and quality assurance(QA) tests as recommended by TG 53 and IEC 430 Treatment Planning System Commissioning and QA Standards. Patient specific dosimetry tests can be performed easily as well.
STANDARD IMAGING INC.
91250
In Commercial Distribution

  • 00850019946529 ()
91250

  • Multi-modality therapeutic radiation phantom, test object
Remidio Portable Slit Lamp (PSL-D20) is a handheld digital device for anterior segment screening & diagnosis of the human eye. High-resolution images obtained with advanced optics and using iPhone’s latest technology. User-friendly iOS enhances the imaging technology and the Remidio patient management application enable the user to view, save, archive, edit and retrieve the captured Anterior Images using a built im-age archival database.
REMIDIO INNOVATIVE SOLUTIONS PRIVATE LIMITED
PSL - D20
In Commercial Distribution

  • 08906096520045 ()
3231680018

  • Ophthalmic examination slit lamp
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