A sterile bioabsorbable material intended to be used to aid in the regeneration of oral soft tissue, lost due to periodontal disease or trauma, primarily through promotion of new blood vessels; it is indicated for various oral soft tissue augmentation proce...

Dental soft-tissue matrix implant, animal-derived

7 GUDID devices

A bioabsorbable animal-derived collagen (e.g., porcine) intended to be used to aid in the regeneration of oral soft tissue, lost due to periodontal disease or trauma, through promotion of new blood vessels and/or by providing a temporary scaffold for tissue...

Soft-tissue/mesh anchor, bioabsorbable

39 GUDID devices

A bioabsorbable device designed to be implanted into ligaments or other soft tissues for soft-tissue approximation and/or to serve as a site of attachment for surgical mesh or sutures; it is not intended to anchor soft tissues to bone, nor repair cartilage,...

Soft-tissue/mesh anchor, bioabsorbable

18 GUDID devices

Software upgrade/unlocking key

16 GUDID devices

A software, hardware, or software/hardware combination device intended to be used to update/upgrade/unlock software embedded on a medical device through the use of an integral or separate media device (e.g., USB flash drive, CD). If supplied on a dedicated ...

External orthopaedic fixation frame web-based calculator software

9 GUDID devices

An application software designed to provide algorithms to assist a physician/surgeon in performing calculations to help create a schedule for the regular adjustment of an external orthopaedic fixation frame (framework) to help facilitate optimum bone growth...

Radiological image interpretive software sharing portal

3 GUDID devices

An application software program designed to function as a portal to allow software providers to make available radiological interpretive software [typically artificial intelligence (AI) based] for radiology professionals to access, use, evaluate, and compar...

Collagen dental regeneration membrane

380 GUDID devices

A sterile bioabsorbable material intended to be used to aid in the regeneration of tooth support, lost due to periodontal disease or trauma, and to regenerate bone defects around implants and at sites intended for implant placement, by acting as a barrier t...

Laboratory instrument/analyser application software IVD

213 GUDID devices

An in vitro diagnostic software program intended to be used with an instrument/analyser (e.g., microscope slide digital imaging scanner, immunoassay analyser, real-time PCR machine), or a data management device connected to the instrument/analyser, to: 1) f...

Mandible-repositioning/palate-lifting sleep-disordered breathing orthosis

148 GUDID devices

A removable intraoral device designed alleviate sleep-disordered breathing conditions (e.g., snoring, obstructive sleep apnoea) by repositioning the lower jaw (mandible), frequently in a downward and forward position, and by elevating the soft palate (soft ...

Soft-tissue/mesh anchor, non-bioabsorbable

122 GUDID devices

A non-bioabsorbable device designed to be implanted into ligaments or other soft tissues to serve as a site of attachment for surgical binding materials/implants (e.g., mesh, sutures); it is not intended to anchor soft tissues to bone, and is not intended f...

Basic diagnostic x-ray system application software

103 GUDID devices

An individual software program or group of programs, routines or algorithms that add specific image processing and/or analysis capabilities to a general-purpose x-ray imaging system configuration. A basic set of applications programs and routines are includ...

MRI system application software

102 GUDID devices

An individual software program or group of programs, routines or algorithms that add specific image processing and/or analysis capabilities to a magnetic resonance imaging (MRI) system configuration. A basic set of applications programs and routines are inc...

Ultrasound imaging system application software

98 GUDID devices

An individual software program or group of programs, routines or algorithms that add specific image processing and/or analysis capabilities to a diagnostic ultrasound system configuration. A basic set of applications programs and routines are included with ...

CT system application software

83 GUDID devices

An application software program intended to add specific image processing and/or analysis capabilities to an x-ray computed tomography (CT) imaging system; it is not dedicated to radiotherapy treatment planning. A basic set of applications programs and rout...

General-purpose dental x-ray system application software

83 GUDID devices

An individual software program or group of programs, routines or algorithms that add specific image processing and/or analysis capabilities to a general-purpose dental x-ray system configuration. A basic set of applications programs and routines are include...

Dental treatment application software

77 GUDID devices

An application software program intended to facilitate dental treatment, which may include dental implant and/or oral/maxillofacial surgery planning, by storing/displaying patient demographics/clinical data and treatment plans, and may control settings for ...

X-ray image interpretive software

68 GUDID devices

An interpretive software program intended to be used to analyse non-dental x-ray images (e.g., chest, mammograms, tomograms) to detect and localize suspected abnormalities (e.g., tumours, emphysema, tuberculosis, blunted costophrenic angle) and possibly pro...

Laboratory analyser operation system software IVD

58 GUDID devices

Mainframe or personal computer (PC) based operating system software (or firmware) that is specific to the central processing unit (CPU) incorporated into an analyser or analyser system. This includes the software or firmware based programs and routines supp...

Operating room audiovisual data/device management system application software

57 GUDID devices

An application software program, routines, and/or algorithms intended to be used in an operating room audiovisual data/device management system to enable the system to function according to its intended purpose. The software typically supports remote contro...

Soft-tissue/mesh anchor, non-bioabsorbable

53 GUDID devices

PET system application software

31 GUDID devices

An individual software program or group of programs, routines or algorithms that add specific image processing and/or analysis capabilities to a positron emission tomography (PET) imaging system configuration. A basic set of applications programs and routin...

Alarm application software

28 GUDID devices

An individual software application program or group of programs, routines or algorithms designed for use in, or together with, an alarm device to enable it to function according to its intended purpose. The basic set of applications programs and routines ca...

Clinical management support software

19 GUDID devices

An application software program intended to facilitate clinical management decisions by receiving patient data from electronic health records and/or manually-entered information (e.g., demographics, diagnostic/laboratory results) and returning clinical care...

MRI image interpretive software

19 GUDID devices

An interpretive software program intended to be used to analyse magnetic resonance imaging (MRI) data (e.g., prostate MRI) to detect and localize suspected abnormalities and sometimes provide results as clinically relevant tags; it may additionally be inten...

Biofeedback system application software

14 GUDID devices

An application software program designed for use in, or together with, a biofeedback system, so that it may function according to its intended purpose. This software program can be permanently installed, or exchanged as an upgrade. It may also be produced f...

Clinical management support software

13 GUDID devices

An application software program intended to facilitate clinical management decisions by receiving structured patient data from electronic health records and/or manually-entered information (e.g., demographics, diagnostic, laboratory results) and returning c...

Endoscopic soft-tissue release system dilator/gauge

13 GUDID devices

A patient-contact dilating/measuring component of an endoscopic soft-tissue release system intended to be used for minimally-invasive transection of soft connective tissue (e.g., fascia, tendon) under direct vision. It consists of a probe-like device that i...

Virtual bronchoscopic navigation PACS software

12 GUDID devices

A software application intended to add specific image processing and/or analysis capabilities to a picture archiving and communication system (PACS) used for virtual bronchoscopic navigation (VBN). It is typically used by a bronchoscopist as a navigation sy...

Human genomic analysis interpretive software

11 GUDID devices

An interpretive software program intended to be used for the analysis and visualization of human genome data from in vitro diagnostic (IVD) results obtained through molecular genetic testing (e.g., whole genome, targeted genome, or exome analyses). It provi...