A sterile flexible tube designed for the percutaneous, transluminal disruption and removal of clotted blood (i.e., a thrombus or thromboembolus) or other formed elements causing vascular obstruction in native and stented blood vessels, native and synthetic ...

Thrombectomy balloon catheter

303 GUDID devices

A sterile flexible tube designed for the percutaneous, transluminal disruption and removal of clotted blood (i.e., a thrombus or thromboembolus) causing vascular obstruction in native and stented blood vessels, native and synthetic bypass grafts, and/or hae...

Thrombectomy suction catheter

284 GUDID devices

A flexible or semi-flexible tube designed for the percutaneous, transluminal disruption and removal of clotted blood (i.e., a thrombus or thromboembolus) or other formed elements causing vascular obstruction in native/stented blood vessels, native/synthetic...

Thrombectomy rotational catheter

76 GUDID devices

A sterile flexible tube designed for the percutaneous, transluminal disruption and removal of clotted blood (i.e., a thrombus or thromboembolus) causing acute vascular obstruction in native and stented blood vessels, or in native and synthetic bypass or hae...

Native DNA antibody (anti-nDNA) IVD, kit, fluorescent immunoassay

46 GUDID devices

A collection of reagents and other associated materials intended to be used for the qualitative and/or quantitative detection of antibodies to native DNA (anti-nDNA) in a clinical specimen, using a fluorescent immunoassay method.

Thrombectomy balloon catheter

42 GUDID devices

A flexible tube designed for the percutaneous, transluminal disruption and removal of clotted blood (i.e., a thrombus or thromboembolus) causing vascular obstruction in native and stented blood vessels, native and synthetic bypass grafts, and/or haemodialys...

Thrombectomy suction catheter

40 GUDID devices

A flexible tube designed for the percutaneous, transluminal disruption and removal of clotted blood (i.e., a thrombus or thromboembolus) or other formed elements causing vascular obstruction in native/stented blood vessels, native/synthetic bypass grafts, a...

Native DNA antibody (anti-nDNA) IVD, reagent

12 GUDID devices

A substance or reactant intended to be used together with a parent IVD to perform a specific function in an assay that is used for the qualitative and/or quantitative detection of antibodies to native DNA (anti-nDNA) in a clinical specimen.

Native DNA antibody (anti-nDNA) IVD, kit, enzyme immunoassay (EIA)

10 GUDID devices

Atherectomy/thrombectomy rotational catheter

4 GUDID devices

A sterile flexible tube designed for the percutaneous, transluminal disruption and removal of atheroma and clotted blood (i.e., a thrombus or thromboembolus) or other formed elements causing acute to chronic vascular obstruction in native and stented blood ...

Native DNA antibody (anti-nDNA) IVD, control

3 GUDID devices

A material which is used to verify the performance of an assay intended to be used for the qualitative and/or quantitative detection of antibodies to native DNA (anti-nDNA) in a clinical specimen.

Collagen wound matrix dressing

738 GUDID devices

A sterile, bioabsorbable, animal-derived collagen protein matrix designed to provide an occlusive/semi-occlusive cover for wound healing (non-oral) and/or a skin template of living cells (fibroblasts) and/or structural proteins to facilitate the infiltratio...

Animal-derived wound matrix dressing

504 GUDID devices

A bioabsorbable animal-derived protein matrix [e.g., peptides derived from collagen] designed to provide: 1) a matrix of structural proteins and/or 2) a skin template of living cells [fibroblasts], to facilitate the infiltration/attachment of native cells/t...

Synthetic wound matrix dressing

114 GUDID devices

A sterile bioabsorbable device designed to be applied to hard-to-heal wounds (e.g., diabetic and venous insufficiency ulcers) or burns that involve the dermis, and that provides a matrix of structural synthetic fibres to facilitate the infiltration of nativ...

Culture medium antimicrobial supplement IVD

69 GUDID devices

A culture medium supplement containing one or multiple antimicrobials that is intended to be used to suppress or inhibit the growth of native or resident microorganisms present in a clinical specimen to enhance recovery, isolation, and/or growth of pathogen...

Carpal lunate prosthesis

38 GUDID devices

A sterile implantable device designed to replace the lunate bone in the proximal carpal row of the wrist typically in the presence of avascular necrosis, localized osteoarthritic changes, or longstanding dislocations. It is typically a one-piece device, mad...

Wound regenerating polysaccharide agent

26 GUDID devices

A sterile device consisting primarily of polysaccharides intended to be used to facilitate the regeneration and repair of tissues affected by a chronic wound (e.g., diabetic foot ulcer, venous ulcer, arterial ulcer, pressure ulcer, bedsore) after wound debr...

Skin regeneration template, human-/animal-derived

24 GUDID devices

A sterile covering used as a temporary skin substitute on wounds (e.g., diabetic or venous insufficiency ulcers) or burns that involve the dermis, and that provides a matrix, typically of living cells (fibroblasts) and/or structural proteins, to facilitate ...

Pulmonary transcatheter heart valve bioprosthesis

18 GUDID devices

A sterile implantable xenograft (e.g., bovine, porcine) intended to be used to repair/replace a stenosed or regurgitant pulmonary heart valve prosthesis (previously implanted), or native pulmonary valve anatomy that may have been surgically repaired, and wh...

Drug-eluting coronary artery stent, fully-bioabsorbable

14 GUDID devices

A bioabsorbable tubular or coil-shaped device with a drug coating intended to be implanted, via a delivery catheter, into a de novo or restenotic native coronary artery during a percutaneous coronary intervention (PCI) to temporarily maintain its patency, t...

Carpal scaphoid prosthesis

10 GUDID devices

A sterile implantable device designed to replace the scaphoid bone in the proximal carpal row of the wrist typically in the presence of avascular necrosis, localized osteoarthritic changes, or longstanding dislocations. It is typically a one-piece device, m...

Pulmonary transcatheter heart valve bioprosthesis

9 GUDID devices

An implantable xenograft (e.g., bovine, porcine) intended to be used to repair/replace a stenosed or regurgitant pulmonary heart valve prosthesis (previously implanted), or native pulmonary valve anatomy that may have been surgically repaired, and which is ...

Vascular-grafting anastomosis system

6 GUDID devices

An assembly of sterile devices designed to create an opening between a blood vessel and a vascular graft (native or synthetic) during a vascular surgical procedure [e.g., coronary artery bypass grafting (CABG), or arteriovenous fistula (AVF) grafting]. It t...

Cadaveric heart valve prosthesis, decellularized, non-sterile

2 GUDID devices

A non-sterile, implantable, allograft heart valve obtained from a human cadaver intended to be used to repair or replace a dysfunctional native or prosthetic heart valve in a patient. It is aseptically processed and treated to render the tissue decellulariz...

Skin allograft

2 GUDID devices

Skin tissue intended for transplantation that is harvested from a human donor genetically different from the human recipient. The implanted tissue is intended to repair, replace, or reinforce skin affected by extensive wounds, burns, and soft tissue defects...

Wound protein matrix solution

2 GUDID devices

A viscous, proteinaceous substance that is topically applied to a wound bed to provide a temporary (degradable) matrix of structural proteins (animal-derived) for the attachment of native cells, to promote wound healing. It is typically contained within a s...

Drug-eluting coronary artery stent, fully-bioabsorbable

1 GUDID devices

Wound matrix solution

1 GUDID devices

A sterile, viscous, proteinaceous substance that is topically applied to a wound bed to provide a temporary (degradable) matrix of structural proteins (animal-derived) for the attachment of native cells, to promote wound healing. It is typically contained w...