A device designed to fix/stabilize a percutaneous catheter, tube, and/or drain (e.g., IV, epidural, or drainage catheter, GI tube) to a patient's body without suturing; it may additionally be intended to protect the catheter/tube access point from impact (e...
A non-surgically invasive device intended to assist a female patient during self-insertion of a urethral drainage catheter (not included). It is typically a moulded plastic device intended to be inserted into the vagina, to allow correct alignment of a guid...
A fully-implantable device assembly intended to provide access to arteries/veins (excludes coronary and intracerebral circulation) for infusion (e.g., chemotherapeutic agents, blood transfusions) and/or drainage (e.g., blood). It consists of: 1) a subcutane...
A sterile implantable xenograft (e.g., bovine) intended to be used to repair/replace a stenosed or regurgitant aortic heart valve, or previously-implanted aortic heart valve prosthesis, and which is designed to be implanted with a catheter via transarterial...
An implantable xenograft (e.g., bovine, porcine) intended to be used to repair/replace a stenosed and/or regurgitant aortic heart valve, or previously-implanted aortic heart valve prosthesis, and which is designed to be implanted with a catheter via transar...
A long, thin, sterile wire designed to provide the necessary length to allow the exchange of a catheter, or other interventional device, while maintaining the intravascular position of the catheter guidewire during an interventional procedure in the periphe...
An implantable xenograft (e.g., bovine, porcine) intended to be used to repair/replace a stenosed or regurgitant aortic heart valve, or previously-implanted aortic heart valve prosthesis, and which is designed to be implanted with a catheter via transarteri...
A collection of sterile devices that includes a urological catheter (with or without a urine drainage bag), a cap, and other related accessories intended for self-urinary catheterization. The catheter may be repeatedly inserted through the urethra by the us...
A collection of non-sterile devices that includes a urological catheter (with or without a urine drainage bag), a cap, and other related accessories intended for self-urinary catheterization. The catheter may be repeatedly inserted through the urethra by th...
A collection of non-sterile devices that includes a urological catheter (with or without a urine drainage bag), a cap, and other related accessories intended for self-urinary catheterization. The catheter may be repeatedly inserted through the urethra by th...
A sterile self-retaining retraction device intended to be used during endoscopic gastrointestinal surgery to improve dissection and submucosal visualization, by providing tension by attachment to the area to be dissected and to the opposing wall within the ...
A shaft with an inflatable balloon at its distal end intended to be used during open cardiovascular surgery to dilate the inflow ring of a sutureless cardiac (heart) valve prosthesis, after its implantation and self expansion, to facilitate valve sealing an...
A dedicated, manually-operated device designed to reduce the diameter of a self-expanding cardiac valve prosthesis during open and/or transcatheter cardiovascular surgery so the collapsed valve can be mounted onto a dedicated holder or catheter to facilitat...
A sterile manually-operated device designed to reduce the diameter of a self-expanding cardiac valve prosthesis during open and/or transcatheter cardiovascular surgery to enable the collapsed valve to be mounted onto a dedicated holder or catheter to facili...
A sterile shaft with an inflatable balloon at its distal end intended to be used during open cardiovascular surgery to dilate the inflow ring of a sutureless cardiac (heart) valve prosthesis, after its implantation and self expansion, to facilitate valve se...
A device designed to reflect undiffused light to assist a disabled person with the self-placement and positioning of a urinary drainage/irrigation catheter (not included) by helping them to see a virtual image of and locate their own urethral orifice. This ...
A sterile collection of devices that includes a urological catheter (with or without a urine drainage bag), a cap, and other related accessories intended for one-time, self-urinary catheterization. The catheter is inserted through the urethra by the patient...
A collection of devices that includes a urological catheter (with or without a urine drainage bag), a cap, and other related accessories (e.g., gloves, drapes, tray) intended for self-urinary catheterization. The catheter may be repeatedly inserted through ...
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...
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 ...
A sterile implantable device intended to provide access to the subarachnoid (intrathecal) space of the spinal column for infusion (e.g., chemotherapeutic agents, pain relieving drugs) and/or drainage [e.g., cerebrospinal fluid (CSF)]. It consists of a subcu...
A device designed to assist a disabled person with the self-placement and positioning of a urinary drainage/irrigation catheter by helping them to see and locate their own urethral orifice. This is a reusable device.
A noninvasive device designed as a conduit through which a small-diameter diagnostic/interventional device(s) can be introduced into or withdrawn from a patient's vasculature while preventing backflow of blood; it might in addition be intended for urinary a...
A sterile non-bioabsorbable tubular device intended to be implanted in an obstructed biliary duct (e.g., common bile duct) to maintain luminal patency. It may be a mesh structure or a continuous tube and is made entirely of metal [e.g., high-grade stainless...
A sterile, flexible tube intended to be inserted percutaneously into the renal pelvis to gain access to the upper urinary tract. This device consists of a large-bore (sizes from 14 to 24 Fr are typical), thin-walled tube usually with a self-retained tip; it...
A non-bioabsorbable tubular device intended to be implanted in an obstructed biliary duct (e.g., common bile duct) to maintain luminal patency; it is not intended for vascular implantation. It may be a mesh structure or a continuous tube and is made entirel...
A non-bioabsorbable tubular device [bare metal stent (BMS)] intended to be implanted in a coronary artery or saphenous vein graft of the heart to maintain luminal patency and improve luminal diameter typically in a patient with symptomatic atherosclerotic h...
A flexible or rigid tube designed for a single insertion into the urethra, typically by the user (i.e., self-applied), to the urinary bladder to provide urine drainage, typically for an individual who is physiologically incapable of voiding. The device is t...
A non-bioabsorbable tubular device intended to be implanted in the common and/or external iliac artery(ies) to maintain arterial patency and luminal diameter in patients with symptomatic atherosclerotic disease. It is made of metal [e.g., stainless steel, n...
A sterile metallic and/or non-metallic device intended to be implanted subcutaneously in a patient for the short- or long-term delivery of fluids or medications to the vascular system or other anatomical region. The device consists of a housing with a self-...