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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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Therapy cycling feedback software
ACCELERATED CARE PLUS CORP
OmniTourSoftware
In Commercial Distribution

  • 00858703006375 ()


  • Bioelectrical signal analysis software
Bioelectrical signal analysis software; Biomechanical function analysis, interactive rehabilitation system
ACCELERATED CARE PLUS CORP
300800A
In Commercial Distribution

  • 00858703006337 ()


  • Bioelectrical signal analysis software
Breathing therapy Biofeedback System
ACCELERATED CARE PLUS CORP
FlowSoftware
In Commercial Distribution

  • 00858703006313 ()


  • Bioelectrical signal analysis software
Intraoral Camera
DENTERPRISE INTERNATIONAL, INC.
1000
In Commercial Distribution

  • 00858475006115 ()
01MAG10000

  • Intraoral camera
Audiometer - Model 650AB
AMBCO ELECTRONICS
650AB
In Commercial Distribution

  • 00851195007011 ()
650AB

  • Tone audiometer
AMBCO Audiometer - Model 650A
AMBCO ELECTRONICS
650A
In Commercial Distribution

  • 00851195007004 ()
650A

  • Tone audiometer
No Description
HEARX GROUP (PTY) LTD
hearTest
In Commercial Distribution

  • 00860003469811 ()


  • Tone audiometer
No Description
Interacoustics A/S
EyeSeeCam
In Commercial Distribution

  • 05711117180565 ()


  • Eye movement analysis system
No Description
Interacoustics A/S
PA5
In Commercial Distribution

  • 05711117180305 ()


  • Tone audiometer
No Description
Interacoustics A/S
AS608
In Commercial Distribution

  • 05711117180244 ()


  • Tone audiometer
No Description
Interacoustics A/S
AD226
In Commercial Distribution

  • 05711117180213 ()


  • Tone audiometer
ParallelTM is a Prescription Digital Therapeutic (PDT) web application designed to deliver Cognitive Behavioral Therapy (CBT) to patients with Irritable Bowel Syndrome (IBS).
Mahana Therapeutics, Inc.
01-0001-001
In Commercial Distribution

  • 00860006172008 ()
01-0001-001

  • Mindfulness/behavioural therapy software, non-clinician-consultative
REMI Vigilenz AI for Event Detection
Epitel, Inc.
1.x.x
In Commercial Distribution

  • 00860005388189 ()
20104

  • Bioelectrical signal analysis software
REMI-Cloud
Epitel, Inc.
2.3
Not in Commercial Distribution

  • 00860005388158 ()


  • Bioelectrical signal analysis software
REMI EEG Monitoring Software (Healthcare Facility module) - v. 2.x.x.x
Epitel, Inc.
2.3.0
In Commercial Distribution

  • 00860005388110 ()


  • Bioelectrical signal analysis software
Regulora® is prescription-only digital therapeutic (PDT) software indicated for use in the treatment of abdominal pain due to Irritable Bowel Syndrome (IBS). The Regulora program is Software as a Medical Device (SaMD) that resides on and is accessed through the user’s mobile device and can be executed at home. Regulora digitizes scripted therapist-administered gut-directed psychotherapy and provides 7 unique treatment sessions, each lasting ~30 minutes, every other week over 12 weeks. The treatment sessions are designed to first induce deep physical and autonomic relaxation which is followed by metaphorical storytelling and a combination of direct and indirect suggestions targeted at somatic control mechanisms. Regulora also provides for IBS symptom tracking, which patients can share with their doctor in the management of their IBS.
Metame Health, Inc.
GDH-1
In Commercial Distribution

  • 00860005970209 ()
60005-97020

  • Mindfulness/behavioural therapy software, non-clinician-consultative
No Description
WAHTS HEARING LLC
0.X.X
In Commercial Distribution

  • 00860005068319 ()


  • Tone audiometer
No Description
WAHTS HEARING LLC
AC 1
In Commercial Distribution

  • 00860005068302 ()


  • Tone audiometer
Salux™ Tablet-Controlled Bluetooth Audiometer - 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 Audiometric solution can be used to display video or static content to the participant.
Examinetics, Inc.
SALUX-AU-02
In Commercial Distribution

SALUX-AU-02

  • Tone audiometer
20GA X 10CM (Breast Localization Needle With Two Wires)
MANAN MEDICAL PRODUCTS, INC.
KOP2010
In Commercial Distribution

  • 20859013006066 ()
  • 10859013006069 ()
  • 00859013006062 ()

  • Length: 10 Centimeter
KOP2010

  • Mammographic stereotactic biopsy system
20GA X 7CM (Breast Localization Needle With Two Wires)
MANAN MEDICAL PRODUCTS, INC.
KOP2007
In Commercial Distribution

  • 20859013006059 ()
  • 10859013006052 ()
  • 00859013006055 ()

  • Length: 7 Centimeter
KOP2007

  • Mammographic stereotactic biopsy system
20 GA X 5 CM Breast Localization Needle With Two Wires
MANAN MEDICAL PRODUCTS, INC.
KOP2005
In Commercial Distribution

  • 20859013006028 ()
  • 10859013006021 ()
  • 00859013006024 ()

  • Length: 5 Centimeter
KOP2005

  • Mammographic stereotactic biopsy system
20GA X 3 CM (Breast Localization Needle With Two Wires)
MANAN MEDICAL PRODUCTS, INC.
KOP2003
In Commercial Distribution

  • 20859013006011 ()
  • 10859013006014 ()
  • 00859013006017 ()

  • Length: 3 Centimeter
KOP2003

  • Mammographic stereotactic biopsy system
Software
PRECISION BIOMETRICS INC
Feature Pack H
In Commercial Distribution

  • 00853818007477 ()


  • Bioelectrical signal analysis software
Software
PRECISION BIOMETRICS INC
Feature Pack G
In Commercial Distribution

  • 00853818007392 ()


  • Bioelectrical signal analysis software
Software
PRECISION BIOMETRICS INC
Feature Pack E
In Commercial Distribution

  • 00853818007101 ()


  • Bioelectrical signal analysis software
Software
PRECISION BIOMETRICS INC
Feature Pack D
In Commercial Distribution

  • 00853818007095 ()


  • Bioelectrical signal analysis software
Software
PRECISION BIOMETRICS INC
Feature Pack C
In Commercial Distribution

  • 00853818007088 ()


  • Bioelectrical signal analysis software
Software
PRECISION BIOMETRICS INC
Feature Pack B
In Commercial Distribution

  • 00853818007071 ()


  • Bioelectrical signal analysis software
Software
PRECISION BIOMETRICS INC
Feature Pack A
In Commercial Distribution

  • 00853818007064 ()


  • Bioelectrical signal analysis software
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