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ev3 Inc

83 FDA 510(k) clearances · Recalling firm

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RecordFirmDate
Medtronic NanoCross Elite PTA catheter, REF numbers amd sizes: 1) AB14W050020090, Size: 5M recall (Z-0904-2025)ev3 Inc2025-01-15
Medtronic TurboHawk Plus Directional Atherectomy System 6F, Multi-vessel, Catalog number T recall (Z-0694-2022)ev3 Inc.2022-03-07
Medtronic TurboHawk Plus Directional Atherectomy System 6F, Small Vessel, Catalog number T recall (Z-0695-2022)ev3 Inc.2022-03-07
Medtronic HawkOne Directional Atherectomy System, Catalog numbers H1-M and H1-M-INT., Mult recall (Z-0450-2022)ev3 Inc.2022-01-19
Medtronic HawkOne Directional Atherectomy System, Catalog numbers H1-S and H1-S-INT, Small recall (Z-0451-2022)ev3 Inc.2022-01-19
ev3, PowerCross" 0.018" OTW PTA Dilatation Catheter, model: AB18W030200150, Sterile EO, Rx recall (Z-1552-2016)ev3, Inc.2016-04-22
ev3 Protege Rx Tapered Carotid Stent System, SECX-10-7-40-135, Sterile EO, Rx only. Indica recall (Z-0878-2015)Ev3, Inc.2014-12-29
ev3, Protg Rx Tapered Carotid Stent System, SEPX-8-6-40-135, Sterile EO, Rx only. Indicate recall (Z-0879-2015)Ev3, Inc.2014-12-29
ev3 EverCross 0.035" OTW PTA Dilatation Catheter, 6mm x 120mm x 135cm, REF: AB35W06120135. recall (Z-1489-2014)Ev3, Inc.2014-04-23
ev3 NanoCross 0.14 OTW PTA Dilatation Catheter, sterilized using ethylene oxide gas. REF # recall (Z-0789-2011)Ev3, Inc.2010-12-23
ev3 Inc. 4600 Nathan Lane, Plymouth, MN Protg " GPS" Self-Expanding Biliary Stent System, recall (Z-0626-2011)Ev3, Inc.2010-12-16
ev3 Protg EverFlex Self-Expanding Biliary Stent System, Sterile EO, (REF: PRB35-06-150-080 recall (Z-1598-2010)Ev3, Inc.2010-05-13
SilverHawk Peripheral Cutter Driver Plaque Excision System REF Catalog No: FG 02550, Steri recall (Z-1162-2010)Ev3, Inc.2010-03-18
TrailBlazer Support Catheter, ev3 inc, 4600 Nathan Lane North, Plymouth, MN 55442-2920, Rx recall (Z-0497-2010)Ev3, Inc.2009-12-23
Protg EverFlex" Self-Expanding Biliary Stent System (for United States distribution). 6 x recall (Z-0478-2010)Ev3, Inc.2009-12-01
ev3 The Endovascular Company, Protege GPS 8mm x 40mm Self Expanding Biliary Stent System, recall (Z-2022-2009)Ev3, Inc.2009-09-08
ev3 The Endovascular Company, Protege GPS 6mm x 80mm Self Expanding Biliary Stent System, recall (Z-2023-2009)Ev3, Inc.2009-09-08
ev3 The Endovascular Company, Protege GPS 6mm x 80mm Self Expanding Peripheral Stent Syste recall (Z-2024-2009)Ev3, Inc.2009-09-08
ev3 The Endovascular Company, Protege GPS 8mm x 40mm Self Expanding Peripheral Stent Syste recall (Z-2025-2009)Ev3, Inc.2009-09-08
ev3" 55442-2920, sterile EO, single Use, Visi-Pro Balloon-Expandable Peripheral Stent Syst recall (Z-1547-2008)Ev3, Inc2008-09-26
ev3" sterile EO, single Use, Visi-Pro Balloon-Expandable Biliary Stent System. Model Numbe recall (Z-1548-2008)Ev3, Inc2008-09-26
ev3 The Endovascular Company, IntraCoil Self-Expanding Peripheral Stent, Model REF VT-6-60 recall (Z-1816-2008)Ev3, Inc2008-09-21
ev3 IntraCoil Self-Expanding Peripheral Stent, Sterile EO, Model REF VT-5-60-135, Lot 4401 recall (Z-1815-2008)Ev3, Inc2008-09-11
Ev3 Protege GPS Biliary Stent Systems 6 mm, 60 mm, 120cm, .35, 6Fr, OTW Ev3 4600 Nathan La recall (Z-2169-2008)Ev3, Inc2008-08-26
Ev3 Primus GPS Biliary Stent System 8 mm, 37 mm, B7, .40 mm, 5Fr, REF BXB35-08-37-75 Use b recall (Z-2170-2008)Ev3, Inc2008-08-26
ev3 IntraStent Biliary Stent, Model Number: S10-26, ev3, 4600 Nathan Lane North, Plymouth, recall (Z-1120-2008)Ev3, Inc2008-05-06
ev3 IntraStent DoubleStrut Biliary Stent, Model Number: S11-16, ev3, 4600 Nathan Lane Nort recall (Z-1121-2008)Ev3, Inc2008-05-06
ev3 IntraStent DoubleStrut Biliary Stent, Model Number: S11-26, ev3, 4600 Nathan Lane Nort recall (Z-1122-2008)Ev3, Inc2008-05-06
ev3 IntraStent DoubleStrut Biliary Stent, Model Number: S11-36, ev3, 4600 Nathan Lane Nort recall (Z-1123-2008)Ev3, Inc2008-05-06
ev3 IntraStent LD DoubleStrut Large Diameter Biliary Stent, Model Number: S15-16, ev3, 460 recall (Z-1124-2008)Ev3, Inc2008-05-06
ev3 IntraStent LD DoubleStrut Large Diameter Biliary Stent, Model Number: S15-36, ev3, 460 recall (Z-1125-2008)Ev3, Inc2008-05-06
ev3 IntraStent LD Mega Large Diameter Biliary Stent, Model Number: S17-16, ev3, 4600 Natha recall (Z-1126-2008)Ev3, Inc2008-05-06
ev3 IntraStent LD Mega Large Diameter Biliary Stent, Model Number: S17-26, ev3, 4600 Natha recall (Z-1127-2008)Ev3, Inc2008-05-06
ev3 IntraStent LD Mega Large Diameter Biliary Stent, Model Number: S17-36, ev3, 4600 Natha recall (Z-1128-2008)Ev3, Inc2008-05-06
ev3 IntraStent LD Max Large Diameter Biliary Stent, Model Number: S18-16, ev3, 4600 Nathan recall (Z-1129-2008)Ev3, Inc2008-05-06
ev3 IntraStent LD Max Large Diameter Biliary Stent, Model Number: S18-26, ev3, 4600 Nathan recall (Z-1130-2008)Ev3, Inc2008-05-06
ev3 IntraStent LD Max Large Diameter Biliary Stent, Model Number: S18-36, ev3, 4600 Nathan recall (Z-1131-2008)Ev3, Inc2008-05-06
Amplatz Goose Neck Snare Kit, 6 Fr, Lot 1650307, REF: GN3000, Use By 2009-09-01, Sterile E recall (Z-0992-2007)Ev3, Inc2007-07-11
ev3 Protege GPS Self-Expanding Nitinol Stent Biliary System. SERB65-09-60-120. recall (Z-0389-2007)Ev3, Inc2007-02-01
X-Sizer Thrombectomy Catheter System (ev3) Model number XD-CS1150-45 (for US distribution) recall (Z-1107-06)Ev3, Inc2006-06-14
X-Sizer Thrombectomy Catheter System (ev3) Model number XD-CS1200-55 (for US distribution) recall (Z-1108-06)Ev3, Inc2006-06-14
Amplatz Goose Neck Microsnare Kit, Model SK400 (175 cm length x 4mm loop snare x .018'',0. recall (Z-0894-06)Ev3, Inc2006-06-02
ev3 Primus GPS Biliary Stent System. Balloon Expandable Stent and Delivery System. The ste recall (Z-0912-06)Ev3, Inc2006-05-31
IntraStent DoubleStrut LD - Balloon Expandable Biliary Stent, Sterilized EO, ev3 4600 Nath recall (Z-0829-06)Ev3, Inc2006-05-03
ev3 Protege GPS Self-Expanding Nitinol Stent Biliary System--- Sterilization with Ethylene recall (Z-0707-06)Ev3, Inc2006-03-18
Primus Biliary Stent and Delivery System. Balloon Expandable Stent and Delivery System. Rx recall (Z-0442-06)Ev3, Inc2006-01-25
ParaMount Mini GPS Biliary Stent System, Balloon Expandable Stent and Delivery System, 7mm recall (Z-0597-04)ev3, Inc.2004-07-20
ParaMount Mini GPS Biliary Stent System, Balloon Expandable Stent and Delivery System, 7mm recall (Z-0598-04)ev3, Inc.2004-07-20
ParaMount Mini GPS Biliary Stent System, Balloon Expandable Stent and Delivery System, 7mm recall (Z-0599-04)ev3, Inc.2004-07-20
ParaMount Mini GPS Biliary Stent System, Balloon Expandable Stent and Delivery System, 6mm recall (Z-0600-04)ev3, Inc.2004-07-20
ParaMount Mini GPS Biliary Stent System, Balloon Expandable Stent and Delivery System, 6mm recall (Z-0601-04)ev3, Inc.2004-07-20
ParaMount Mini GPS Biliary Stent System, Balloon Expandable Stent and Delivery System, 6mm recall (Z-0602-04)ev3, Inc.2004-07-20
ParaMount Mini GPS Biliary Stent System, Balloon Expandable Stent and Delivery System, 5mm recall (Z-0603-04)ev3, Inc.2004-07-20
ParaMount Mini GPS Biliary Stent System, Balloon Expandable Stent and Delivery System, 5mm recall (Z-0604-04)ev3, Inc.2004-07-20
ParaMount Mini GPS Biliary Stent System, Balloon Expandable Stent and Delivery System, 5mm recall (Z-0605-04)ev3, Inc.2004-07-20
ParaMount Mini GPS Biliary Stent System, Balloon Expandable Stent and Delivery System 7mm recall (Z-0606-04)ev3, Inc.2004-07-20
ParaMount Mini GPS Biliary Stent System, Balloon Expandable Stent and Delivery System 7mm recall (Z-0607-04)ev3, Inc.2004-07-20
ParaMount Mini GPS Biliary Stent System, Balloon Expandable Stent and Delivery System 7mm recall (Z-0608-04)ev3, Inc.2004-07-20
ParaMount Mini GPS Biliary Stent System, Balloon Expandable Stent and Delivery System 6mm recall (Z-0609-04)ev3, Inc.2004-07-20
ParaMount Mini GPS Biliary Stent System, Balloon Expandable Stent and Delivery System 6mm recall (Z-0610-04)ev3, Inc.2004-07-20
ParaMount Mini GPS Biliary Stent System, Balloon Expandable Stent and Delivery System 6mm recall (Z-0611-04)ev3, Inc.2004-07-20
ParaMount Mini GPS Biliary Stent System, Balloon Expandable Stent and Delivery System 5mm recall (Z-0612-04)ev3, Inc.2004-07-20
ParaMount Mini GPS Biliary Stent System, Balloon Expandable Stent and Delivery System 5mm recall (Z-0613-04)ev3, Inc.2004-07-20
ParaMount Mini GPS Biliary Stent System, Balloon Expandable Stent and Delivery System 5mm recall (Z-0614-04)ev3, Inc.2004-07-20
ParaMount Mini GPS Stent System, Peripheral System, Balloon Expandable Stent and Delivery recall (Z-0615-04)ev3, Inc.2004-07-20
ParaMount Mini GPS Stent System, Peripheral System, Balloon Expandable Stent and Delivery recall (Z-0616-04)ev3, Inc.2004-07-20
ParaMount Mini GPS Stent System, Peripheral System, Balloon Expandable Stent and Delivery recall (Z-0617-04)ev3, Inc.2004-07-20
ParaMount Mini GPS Stent System, Peripheral System, Balloon Expandable Stent and Delivery recall (Z-0618-04)ev3, Inc.2004-07-20
ParaMount Mini GPS Stent System, Peripheral System, Balloon Expandable Stent and Delivery recall (Z-0619-04)ev3, Inc.2004-07-20
ParaMount Mini GPS Stent System, Peripheral System, Balloon Expandable Stent and Delivery recall (Z-0620-04)ev3, Inc.2004-07-20
ParaMount Mini GPS Stent System, Peripheral System, Balloon Expandable Stent and Delivery recall (Z-0621-04)ev3, Inc.2004-07-20
ParaMount Mini GPS Stent System, Peripheral System, Balloon Expandable Stent and Delivery recall (Z-0622-04)ev3, Inc.2004-07-20
ParaMount Mini GPS Stent System, Peripheral System, Balloon Expandable Stent and Delivery recall (Z-0623-04)ev3, Inc.2004-07-20
ParaMount Mini GPS Stent System, Peripheral System, Balloon Expandable Stent and Delivery recall (Z-0624-04)ev3, Inc.2004-07-20
ParaMount Mini GPS Stent System, Peripheral System, Balloon Expandable Stent and Delivery recall (Z-0625-04)ev3, Inc.2004-07-20
ParaMount Mini GPS Stent System, Peripheral System, Balloon Expandable Stent and Delivery recall (Z-0626-04)ev3, Inc.2004-07-20
ParaMount Mini GPS Stent System, Peripheral System, Balloon Expandable Stent and Delivery recall (Z-0627-04)ev3, Inc.2004-07-20
ParaMount Mini GPS Stent System, Peripheral System, Balloon Expandable Stent and Delivery recall (Z-0628-04)ev3, Inc.2004-07-20
ParaMount Mini GPS Stent System, Peripheral System, Balloon Expandable Stent and Delivery recall (Z-0629-04)ev3, Inc.2004-07-20
ParaMount Mini GPS Stent System, Peripheral System, Balloon Expandable Stent and Delivery recall (Z-0630-04)ev3, Inc.2004-07-20
ParaMount Mini GPS Stent System, Peripheral System, Balloon Expandable Stent and Delivery recall (Z-0631-04)ev3, Inc.2004-07-20
ParaMount Mini GPS Stent System, Peripheral System, Balloon Expandable Stent and Delivery recall (Z-0632-04)ev3, Inc.2004-07-20
Protg Self-Expanding Nitinol Stent 6 mm x 40 mm, Model Number SER6-6-40-135 recall (Z-0863-03)ev3, Inc.2003-05-22

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