BEUDAMED
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    Reusable laparoscopic instruments are packaged as non-sterile. Cleaning and sterilization of devices must occur prior to use. The instruments are intended to be used by qualified physicians to provide access, illumination and visualization of internal structures and for manipulating soft tissue (grasping, cutting, coagulating, dissecting and suturing) in a wide variety of diagnostic and therapeutic laparoscopic/ urologic closed and minimally invasive procedures. It is inserted via a trocar sleeve and is used to prepare, coagulate and cut tissue.

    FDA Enforcement
    Class II ·Terminated·Instrumed International, Inc.·October 8, 2014

    Reusable laparoscopic instruments are packaged as non-sterile. Cleaning and sterilization of devices must occur prior to use. The instruments are intended to be used by qualified physicians to provide access, illumination and visualization of internal structures and for manipulating soft tissue (grasping, cutting, coagulating, dissecting and suturing) in a wide variety of diagnostic and therapeutic laparoscopic/ urologic closed and minimally invasive procedures. It is inserted via a trocar sleeve and is used to prepare, coagulate and cut tissue.

    FDA Enforcement
    Class II ·Terminated·Instrumed International, Inc.·October 8, 2014

    MicroCutter Xchange 30 Blue Curved Tip Cartridge. Model Number: FG-025321; The MicroCutter XCHANGE 30 Blue Cartridge and MicroCutter XCHANGE 30 Blue Curved Tip Cartridge contain 316L stainless steel staples. The cartridges are used with the MicroCutter XCHANGE 30 Stapler, which is a single patient device. When the MicroCutter XCHANGE 30 Stapler is loaded with a MicroCutter XCHANGE 30 Cartridge, two double rows of 316L stainless steel staples are delivered while simultaneously transecting tissue between the two, double staple rows. The MicroCutter XCHANGE 30 Stapler and MicroCutter XCHANGE 30 Cartridge are designed for introduction and use through a 5mm trocar cannula or larger. The staple line length is 30 mm long. The Stapler can be loaded, fired, and reloaded with the MicroCutter XCHANGE 30 Cartridge for up to the number deployments indicated on package label in a single surgical procedure. The Stapler can fire different sized staples, with the size of the staple indicated by the color of the MicroCutter XCHANGE Cartridges. Intended for use in multiple open or minimally invasive surgical procedures for the transaction, resection, and /or creation of anastomoses in small and large intestine as well as the transection of the appendix.

    FDA Enforcement
    Class II ·Terminated·Cardica, Inc.·December 30, 2015

    MicroCutter Xchange 30 Blue Cartridge, FG-025320; The MicroCutter XCHANGE 30 Blue Cartridge and MicroCutter XCHANGE 30 Blue Curved Tip Cartridge contain 316L stainless steel staples. The cartridges are used with the MicroCutter XCHANGE 30 Stapler, which is a single patient device. When the MicroCutter XCHANGE 30 Stapler is loaded with a MicroCutter XCHANGE 30 Cartridge, two double rows of 316L stainless steel staples are delivered while simultaneously transecting tissue between the two, double staple rows. The MicroCutter XCHANGE 30 Stapler and MicroCutter XCHANGE 30 Cartridge are designed for introduction and use through a 5mm trocar cannula or larger. Intended for use in multiple open or minimally invasive surgical procedures for the transaction, resection, and /or creation of anastomoses in small and large intestine as well as the transection of the appendix.

    FDA Enforcement
    Class II ·Terminated·Cardica, Inc.·December 30, 2015

    Cambridge Endoscopic Autonomy Laparo-Angle 5mm Metzenbaum Scissors with Monopolar Cautery, 45 cm Catalog Number: LA1101-12 Intended for use in a variety of minimally invasive procedures to facilitate grasping, mobilization, dissection, and transection of tissue.

    FDA Recall
    Terminated ·Cambridge Endoscopic Devices, Incorporated·Product code GEI·May 20, 2011

    Cambridge Endoscopic Autonomy Laparo-Angle 5mm Metzenbaum Scissors with Monopolar Cautery, 34cm Catalog Number: LA1101-01 Intended for use in a variety of minimally invasive procedures to facilitate grasping, mobilization, dissection, and transection of tissue.

    FDA Recall
    Terminated ·Cambridge Endoscopic Devices, Incorporated·Product code GEI·May 20, 2011

    Zimmer Minimally Invasive Solutions Technology Offset Rasp Handle, Left, 30 degrees, Zimmer, Warsaw, IN; REF 00-7806-035-01. The offset rasp handle is a surgical instrument used with various sizes of femoral rasps to prepare the femoral canal for a hip implant.

    FDA Recall
    Terminated ·Zimmer Inc.·Product code LXH·December 19, 2008

    Zimmer Minimally Invasive Solutions Technology Offset Rasp Handle, Right, 30 degrees, Zimmer, Warsaw, IN; REF 00-7806-035-02. The offset rasp handle is a surgical instrument used with various sizes of femoral rasps to prepare the femoral canal for a hip implant.

    FDA Recall
    Terminated ·Zimmer Inc.·Product code LXH·December 19, 2008

    Biopsy Forceps, Hot Model #'s: BAL60110 BAR000852 BAR000854 and MIC1550 Laparoscopic electric instruments are designed for use in minimally invasive procedures and open surgical procedures to facilitate coagulation, transection, resection, mobilization, and dissection of tissue.

    FDA Recall
    Terminated ·Sterilmed Inc·Product code NLU·August 8, 2008

    Scissor Tips Model #'s: AESPO888 AESPO889 ENCES0102 MIC3112 MIC3122 MIC3142 MIC3152 SNO89-5100 and SNO89-5300 Intended to be used with a resusable hand piece and are designed to use in minimally invasive and open surgical procedures to facilitate coagulation, preparation, mobilization, and cutting tissue.

    FDA Recall
    Terminated ·Sterilmed Inc·Product code NUJ·August 8, 2008

    Lap Instruments/Graspers/Forceps - HOT Model #'s: AUT173016 AUT174301 AUT176643 AUT176643 ETH5DCD ETH5DCS ETHEBF01 ETHPOUCH GYR3000PK GYR3005PK GYR3640 and GYR920005PK Laparoscopic electric instruments are designed for use in minimally invasive procedures and/or open surgical procedures to facilitate coagulation, transaction, resection, mobilization and dissection of tissue.

    FDA Recall
    Terminated ·Sterilmed Inc·Product code NUJ·August 8, 2008

    Insufflator, laparoscopic The ConMed GS2000, Smith & Nephew 500, Novadaq 50L and Nebulae I insufflators are devices that provide CO2 gas distention of surgical cavities for diagnostic and/or operative endoscopy. The insufflator has multiple operating modes which can be used for the following procedures: General Laparoscopic, Pediatric Laparoscopic, Bariatric Laparoscopic and Minimally Invasive Vessel Harvesting procedures

    FDA Recall
    Terminated ·Northgate Technologies, Inc.·Product code HIF·November 21, 2016

    ENDOPATH ETS Compact Flex (240 mm shaft length) Linear Cutters, Model Number(s): SCW45; CTS45; SCB45; CTS45NK; 6CB45 and SCG45. Mfr. By: Ethicon Endo-Surgery, LLC, Guaynabo, PR 00969 The ETS Compact-Flex45 Articulating Linear Cutter is intended for transection, resection, and/or creation of anastomoses. The instruments have application in multiple open or minimally invasive general, gynecologic, urologic, thoracic, and pediatric surgical procedures. They can be used with staple line or tissue buttressing materials.

    FDA Recall
    Terminated ·Ethicon Endo-Surgery Inc·Product code GDW·July 29, 2011

    MicroCutter Xchange 30 Blue Cartridge, FG-025320; The MicroCutter XCHANGE 30 Blue Cartridge and MicroCutter XCHANGE 30 Blue Curved Tip Cartridge contain 316L stainless steel staples. The cartridges are used with the MicroCutter XCHANGE 30 Stapler, which is a single patient device. When the MicroCutter XCHANGE 30 Stapler is loaded with a MicroCutter XCHANGE 30 Cartridge, two double rows of 316L stainless steel staples are delivered while simultaneously transecting tissue between the two, double staple rows. The MicroCutter XCHANGE 30 Stapler and MicroCutter XCHANGE 30 Cartridge are designed for introduction and use through a 5mm trocar cannula or larger. Intended for use in multiple open or minimally invasive surgical procedures for the transaction, resection, and /or creation of anastomoses in small and large intestine as well as the transection of the appendix.

    FDA Recall
    Terminated ·Cardica, Inc.·Product code GDW·November 6, 2015

    DIAMONDBACK 360 Peripheral 1.50 Classic, Model DBP-150CLASS145 Peripheral Orbital Atherectomy System (OAS) is a minimally invasive, catheter-based OAS designed for improving luminal diameter in patients with peripheral arterial disease (PAD). PAD is caused by the accumulation of plaque in the arteries of the leg or foot and reduces blood flow that may lead to pain, tissue loss, and eventual foot amputation, leg amputation or death. The system treats a broad range of plaque types in the lower limbs The DIAMONDBACK 360 Peripheral Orbital Atherectomy System is a percutaneous orbital atherectomy system indicated for use as therapy in patients with occlusive atherosclerotic disease in peripheral arteries and who are acceptable candidates for percutaneous transluminal atherectomy. The OAS supports removal of stenotic material from artificial arteriovenous dialysis fistulae (AV shunt). The system is a percutaneous orbital atherectomy system indicated as a therapy in patients with occluded hemodialysis grafts who are acceptable candidates for percutaneous transluminal angioplasty. The Stealth 360 Orbital PAD System is a percutaneous orbital atherectomy system indicated for use as therapy in patients with occlusive atherosclerotic disease in peripheral arteries and who are acceptable candidates for percutaneous transluminal atherectomy.

    FDA Recall
    Terminated ·Cardiovascular Systems Inc·Product code MCW·December 7, 2016

    PNEUMOCLEAR Heated High-Flow Tube Set Product Usage: The Heated High-Flow Tube Set is a single use sterile tube set used in combination with the PNEUMOCLEAR C02 insufflator as a separate accessory. The device PNEUMOCLEAR is a C02 insufflator intended for use during diagnostic and/or therapeutic endoscopic procedures to distend a cavity by filling it with gas. The Standard, High Flow/Bariatric, Pediatric and Advanced Flow operating mode of the device are indicated to fill and distend a peritoneal cavity with gas during a laparoscopic procedure. The Pediatric operating mode is indicated for pediatric laparoscopic procedures. The Vessel Harvest operating mode is indicated for use during endoscopic vessel harvesting procedures to create a cavity along the saphenous vein or radial artery. The TAMIS operating mode is indicated to fill and distend the rectum and colon using C02 gas during trans anal minimal invasive surgery.

    FDA Recall
    Terminated ·WOM World of Medicine AG Salzufer 8 Berlin Germany·Product code HIF·October 22, 2018

    Endopath Electrosurgery Probe Plus II, twelve (12) different devices, including hooks, spatulas, right angles, curved dissectors, suction/irrigation devices, accessory ports, pool/sump devices and stone retrieval cannula, packaged and sterilized individually in a transparent flexible blister sealed to a Tyvek lid. 6 flexible packages are placed into a sales unit carton, with 4 cartons per corrugated shipper. The Endopath Electrosurgery Probe Plus II system has application in minimally invasive procedures to facilitate tissue dissection, coagulation, irrigation, and fluid evacuation through a common trocar sleeve.

    FDA Recall
    Terminated ·Ethicon Endo-Surgery Inc·Product code GCJ·April 8, 2013

    MicroCutter Xchange 30 Blue Curved Tip Cartridge. Model Number: FG-025321; The MicroCutter XCHANGE 30 Blue Cartridge and MicroCutter XCHANGE 30 Blue Curved Tip Cartridge contain 316L stainless steel staples. The cartridges are used with the MicroCutter XCHANGE 30 Stapler, which is a single patient device. When the MicroCutter XCHANGE 30 Stapler is loaded with a MicroCutter XCHANGE 30 Cartridge, two double rows of 316L stainless steel staples are delivered while simultaneously transecting tissue between the two, double staple rows. The MicroCutter XCHANGE 30 Stapler and MicroCutter XCHANGE 30 Cartridge are designed for introduction and use through a 5mm trocar cannula or larger. The staple line length is 30 mm long. The Stapler can be loaded, fired, and reloaded with the MicroCutter XCHANGE 30 Cartridge for up to the number deployments indicated on package label in a single surgical procedure. The Stapler can fire different sized staples, with the size of the staple indicated by the color of the MicroCutter XCHANGE Cartridges. Intended for use in multiple open or minimally invasive surgical procedures for the transaction, resection, and /or creation of anastomoses in small and large intestine as well as the transection of the appendix.

    FDA Recall
    Terminated ·Cardica, Inc.·Product code GDW·November 6, 2015

    Vasoview Hemopro Endoscopic Vessel Harvesting System Maquet Cardiovascular LLC 45 Barbour Pond Drive Wayne, NJ 07470 Indicated for use in minimally invasive surgery allowing access for vessel harvesting and is primarily indicated for patients undergoing endoscopic surgery for arterial bypass. It is indicated for cutting tissue and controlling bleeding through coagulation, and for patients requiring blunt dissection of tissue including dissection of blood vessels, dissection of blood vessels oft he extremities, dissection of ducts and other structures int he extraperitoneal or subcutaneous extremity and thoracic space. Extremity procedures include tissue dissection/vessel harvesting along the saphenous vein for use in coronary artery bypass grafting and peripheral artery bypass or the radial artery for use in coronary artery bypass grafting. Thorascopic procedures include exposure and dissection of structures external to the parietal pleura including nerves blood vessels and other tissues of the chest wall.

    FDA Recall
    Terminated ·Maquet Cardiovascular, LLC·Product code GEI·October 30, 2013