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The UMED REPROCESSED CTC VP 520 FOOT CUFF is used in the same manner as intended by the original device manufacturer (OEM) to increase venous blood flow in patients at risk of developing Deep Vein Thrombosis (DVT) and pulmonary embolism (PE). The device is a prescription device for the use in a clinical setting or in the home. The UMED REPROCESSED CTC VP 501 CALF CUFF is used in the same manner as intended by the original device manufacturer (OEM) to increase venous blood flow in patients at risk of developing Deep Vein Thrombosis (DVT) and pulmonary embolism (PE). The device is a prescription device for the use in a clinical setting or in the home. The UMED REPROCESSED AIRCAST ELITE CALF CUFF 3040 / 3050 is used in the same manner as intended by the original device manufacturer (OEM) to increase venous blood flow in at-risk patients in order to prevent deep vein thrombosis (DVT) and. The device is a prescription device for the use in a clinical setting or in the home. The UMED REPROCESSED KENDALL SCD EXPRESS SLEEVE is used in the same manner as intended by the original device manufacturer (OEM) to increase venous blood flow in patients at risk of developing Deep Vein Thrombosis (DVT) and pulmonary embolism (PE). The device is a prescription device for the use in a clinical setting or in the home. The UMED REPROCESSED AIRCAST VENAFLOW FOOT CUFF is used in the same manner as intended by the original device manufacturer (OEM) to increase venous blood flow in at- risk patients in order to prevent deep vein thrombosis (DVT). The device is a prescription device for the use in a clinical setting or in the home.

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Applied Medical's Inzii Ripstop Redeployable Retrieval System is indicated for use as a receptacle for the collection and extraction of tissue, organs, and calculi during general and laparoscopic surgical procedures.

The Inzii Ripstop Redeployable Retrieval System is a single-use device designed for the containment and extraction of multiple tissue specimens. The device consists of a flexible specimen bag and an introducer tube which can be redeployed for multiple uses within a single procedure. The product will be available in two models, a 10 mm model with a 265 ml specimen bag and a 15 mm model with a 1600 ml specimen bag size. The device is provided sterile and is constructed of a Ripstop nylon specimen bag, various polymers and stainless steel. The major differences between the predicate and the subject device include the subject device featuring a stronger Ripstop nylon specimen bag and the ability to be redeployed multiple times within a single surgical procedure.

The Voyant Maryland Fusion Device with Single-Step Activation is a bipolar, electrosurgical device indicated for use with the Voyant electrosurgical generator in open and laparoscopic procedures where the ligation of vessels and tissue bundles is desired. The device can seal and divide vessels up to and including 7mm in diameter and tissue bundles that can be captured in the jaws of the device. The device has not been shown to be effective for tubal coagulation for sterilization procedures, and should not be used for these procedures.

The Voyant Maryland Fusion device with Single Step is an advanced bipolar instrument that uses RF energy, provided by the Voyant Electrosurgical Generator (K182244), to seal vessels up to and including 7mm in diameter. The device may also be used to seal tissue bundles that can be captured in the device jaws. The device features a mechanical, user-actuated blade for the division of sealed tissue.

The GelPOINT V-Path Vaginal Access System (VAS) is intended to be inserted in the vagina to allow for entry of minimally invasive instruments while maintaining insufflation for vaginal gynecological procedures.

The GelPOINT V-Path Vaginal Access System consists of an Intravaginal Alexis retractor and two access channels that are placed vaginally to create a pathway to gynecological organs. A GelSeal cap attaches to the retractor at the opening of the vagina. The cap allows for insufflation and smoke evacuation. Sleeves inserted through the cap allow for passage of 5mm to 12mm instrumentation. Visualization is achieved via introduction of an endoscope through a sleeve. The device is provided sterile.

The Alexis® Contained Extraction System is indicated to contain and isolate tissue during, or prior to, surgical removal and/or extracorporeal manual morcellation via an abdominal or vaginal approach.

The Alexis® Contained Extraction System is a sterile, single use tissue bag with a guard system component. The polyurethane tissue bag consists of a flexible ring, tabs, strap with a snap fastener, and an attached tether It is available in two models GTB14 and GTB17 with the following dimensions and volumes: Model | Ring Diameter | Volume ------- | -------- | -------- GTB14 | 14 cm | 3,400 mL GTB17 | 17 cm | 6,500 mL The tissue bag is used to contain and isolate specimens for surgical removal and/or manual morcellation. The strap with snap fastener maintains the folded bag and flexible ring in a collapsed state during insertion. After the device is fully inserted and deployed into the abdominal or pelvic cavity, the opening of the bag returns to its original, circular shape, facilitating placement of the specimen in the bag. When the specimen is ready for removal and/or manual morcellation, the tether, tabs, and strap are used to maneuver the ring to the surface of the extraction site. If the specimen requires manual morcellation. the ring may be repeatedly flipped to shorten the bag and consequently bring the specimen closer to the extraction site. The guard system consists of a guard and a self-retaining retractor. The guard is composed of a coiled polyethylene material that conforms to the extraction site. The self-retaining retractor consists of two polyurethane rings connected by a polyurethane sheath and a tether attached to the inner ring. It helps anchor the guard at the extraction site. The guard system provides a robust barrier between the bag and sharp instruments. The Alexis® Contained Extraction System can be inserted and retrieved either through an abdominal incision or through the vaginal canal and colpotomy. In both cases, manual morcellation is performed extracorporeally at the extraction site.

Python catheters are indicated for removal of thromboemboli from the peripheral arterial system, and for occlusion and infusion of fluids into a vessel. The Over-the-Wire Latis Graft Cleaning Catheter is indicated for the removal of thromboemboli from vascular grafts, and for occlusion and infusion of fluids into a graft.

The Python Embolectomy Catheter & Over-the-Wire Latis Graft Cleaning Catheters are sterile, single use vascular balloon catheters intended for use in the removal of thromboemboli, occlusion of vessels, and the infusion of fluids. The devices are intended for use in arterial vessels and artificial vascular grafts respectively. The body of the catheters utilize a dual lumen design with one inflation lumen used to inflate the balloon, and one through lumen allowing for insertion over a guide wire or infusion of fluids. The outer diameter of the body is designed to accommodate use with a standard percutaneous access sheath. The Over-the-wire Latis Graft Cleaning Catheter includes a braided mesh which surrounds the balloon and is designed to increase engagement with wall of artificial vascular graft.

The Applied Medical Anoscope is intended for transanal use to provide physicians access to the anal sphincter, anus, and rectum and to perform various diagnostic and therapeutic procedures using additional accessories.

The Applied Medical Anoscope consists of a one-piece polycarbonate half round channel with a tapered closed tip. The device retracts the anal sphincter and provides access to the anorectal anatomy during transanal procedures.

The Voyant Open Fusion Device is a bipolar, electrosurgical device indicated for use with the Voyant electrosurgical generator in open procedures where the ligation and division of vessels and tissue bundles is desired. The device can seal and divide vessels up to and including 7mm in diameter and tissue bundles that can be captured in the jaws of the device. The device has not been shown to be effective for tubal coagulation for sterilization for sterilization procedures, and should not be used for these procedures. The Voyant 5mm Fusion device is a bipolar, electrosurgical device indicated for use with the Voyant electrosurgical generator in open and laparoscopic procedures where the ligation and division of vessels and tissue bundles is desired. The device can seal and divide vessels up to and including 7mm in diameter and tissue bundles that can be captured in the jaws of the device. The device has not been shown to be effective for tubal coagulation for sterilization for sterilization procedures, and should not be used for these procedures.

The Voyant Open Fusion and Voyant 5mm Fusion devices are advanced bipolar instruments that use RF energy, provided by the Voyant Electrosurgical Generator (K182244), to seal vessels up to and including 7mm in diameter. The devices may also be used to seal tissue bundles that can be captured in the devices' jaws. Each device features a mechanical, user-actuated blade for the division of sealed tissue.

The Voyant Maryland Fusion device is a bipolar, electrosurgical device indicated for use with the Voyant electrosurgical generator in open and laparoscopic procedures where the ligation of vessels and tissue bundles is desired. The device can seal and divide vessels up to and including 7mm in diameter and tissue bundles that can be captured in the jaws of the device. The device has not been shown to be effective for tubal coagulation for sterilization procedures, and should not be used for these procedures.

The Voyant Maryland Fusion device is an advanced bipolar instrument that uses RF energy, provided by the Voyant Electrosurgical Generator (K182244), to seal vessels up to and including 7mm in diameter. The device may also be used to seal tissue bundles that can be captured in the device jaws. The device features a mechanical, user-actuated blade for the division of sealed tissue.

The Voyant [5mm/Maryland] Fusion device is a bipolar, electrosurgical device indicated for use with the Voyant electrosurgical generator in open and laparoscopic procedures where the ligation of vessels and tissue bundles is desired. The device can seal and divide vessels up to and including 7mm in diameter and tissue bundles that can be captured in the jaws of the device. The device has not been shown to be effective for tubal sterilization or tubal coagulation for sterilization procedures, and should not be used for these procedures.

The Voyant 5mm and Maryland Fusion devices are advanced bipolar instruments that uses RF energy, provided by the Voyant Electrosurgical Generator (K141288 & K182244), to seal vessels up to and including 7mm in diameter. The devices may also be used to seal tissue bundles that can be captured in the device jaws. The devices feature a mechanical, user-actuated blade for the division of sealed tissue.