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Surgical Devices/Covidien

21 FDA 510(k) clearances · Recalling firm

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RecordFirmDate
SurgASSIST System Storage Cart, product code CART; SurgASSIST Service Manual, product code recall (Z-0392-2010)Surgical Devices/Covidien2009-11-23
Circular Stapler 21 mm Digital Loading Unit, product code CS21; Circular Stapler 25 mm Dig recall (Z-0393-2010)Surgical Devices/Covidien2009-11-23
Right Angle Linear Cutter, 30 mm Digital Loading Unit, product code RALC30; Right Angle Li recall (Z-0394-2010)Surgical Devices/Covidien2009-11-23
Remote Control Unit with Wire, product code RCW100. recall (Z-0395-2010)Surgical Devices/Covidien2009-11-23
Straight Linear Cutter 55 mm Blue Digital Loading Unit, product code SLC55B; Straight Line recall (Z-0396-2010)Surgical Devices/Covidien2009-11-23
FlexShaft, product code FS14; FlexShaft II, product code FS214; FlexShaft III, product cod recall (Z-0397-2010)Surgical Devices/Covidien2009-11-23
Power Linear Cutter 75 mm, Reusable Digital Loading Unit, product code PLC75; Power Linear recall (Z-0398-2010)Surgical Devices/Covidien2009-11-23
Power Extender Straight, product code PES100; Power Extender Straight Reconditioned, produ recall (Z-0399-2010)Surgical Devices/Covidien2009-11-23
Endoscopic Linear Cutter Reload, 45 mm Blue, product code PLCR45B; Endoscopic Linear Cutte recall (Z-0400-2010)Surgical Devices/Covidien2009-11-23
Power Circular Stapler 21 mm Digital Loading Unit, product code PCS21; Power Circular Stap recall (Z-0401-2010)Surgical Devices/Covidien2009-11-23
Power Console, product code PC100; Power Console System, product code PC100S; Power Consol recall (Z-0402-2010)Surgical Devices/Covidien2009-11-23
Sterile Sheath, product code SS01. recall (Z-0403-2010)Surgical Devices/Covidien2009-11-23
Program Memory Card, product code MCV1A. recall (Z-0404-2010)Surgical Devices/Covidien2009-11-23
Intelligent Reload, 45 mm Blue, product code iR45B; Intelligent Reload, 45 mm Green, produ recall (Z-0405-2010)Surgical Devices/Covidien2009-11-23
Intelligent Delivery System, Straight, product code iDriveS; Intelligent Delivery System, recall (Z-0406-2010)Surgical Devices/Covidien2009-11-23
Intelligent 60mm Straight Endoscopic Linear Cutter, product code i60S; Intelligent 60mm St recall (Z-0407-2010)Surgical Devices/Covidien2009-11-23
Intelligent 60mm Articulating Endoscopic Linear Cutter, product code i60; Intelligent 60mm recall (Z-0408-2010)Surgical Devices/Covidien2009-11-23
Intelligent Battery Pack, product code iB100; Intelligent Battery Charger and Power Supply recall (Z-0409-2010)Surgical Devices/Covidien2009-11-23
Rigid Curved Positioner, product code RCP; Rigid Curved Positioner O-Ring, product code RC recall (Z-0410-2010)Surgical Devices/Covidien2009-11-23
Device Sterilization Tray, product code T300. recall (Z-0411-2010)Surgical Devices/Covidien2009-11-23
Power Supply -not sold separately, product code PWSP; Power Cord - Not sold separately, pr recall (Z-0412-2010)Surgical Devices/Covidien2009-11-23

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Every clearance here is in the API, with alerts when new ones post.