51 results
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18ms
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Sources: EU EUDAMED, US FDA
Filters
Classification: Class Ii
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Artegraft¿ Collagen Vascular Graft; REF: AG1015;
FDA Enforcement
Class II
·Ongoing·LeMaitre Vascular, Inc.·October 29, 2025
Artegraft Collagen Vascular Graft. Model/Catalog/Part Numbers: AG630M, AG636M, AG730M, AG740M, AG845M. The Artegraft is intended to serve as a substitute conduit for blood where bypass or replacement of occluded or diseased arterial segments is required or to establish a conduit for hemodialysis.
FDA Enforcement
Class II
·Ongoing·LeMaitre Vascular, Inc.·October 15, 2025
Artegraft Collagen Vascular Grafts Model Numbers: (1) AG 616, (2) AG 630, (3) AG 636, (4) AG 640, (5) AG 645, (6) AG 715, (7) AG 730, (8) AG 735, (9) AG 740, (10) AG 745, (11) AG 750, (12) AG 830, (13) AG 840, (14) AG 1015, (15) AG 1030;
FDA Enforcement
Class II
·Ongoing·LeMaitre Vascular, Inc.·October 8, 2025
Pruitt Occlusion Catheter. Catalog Numbers: 2103-36, 2103-46, 2103-56, E2103-36, E2103-46, E2103-56
FDA Enforcement
Class II
·Ongoing·LeMaitre Vascular, Inc.·May 21, 2025
TufTex Over-the-Wire Embolectomy Catheter. All Catalog numbers: 1651-34, 1651-38, 1651-44, 1651-48, 1651-58, 1651-64, 1651-68, 1651-78, 1651-84, 1651-88, E1651-34, E1651-38, E1651-44, E1651-48, E1651-64, E1651-68, E1651-78, E1651-84, E1651-88, 1651-44J, 1651-48J, 1651-84J, 1651-88J.
FDA Enforcement
Class II
·Ongoing·LeMaitre Vascular, Inc.·May 21, 2025
Pruitt Irrigation Occlusion Catheter. Catalog Numbers: 2102-09, E2102-09.
FDA Enforcement
Class II
·Ongoing·LeMaitre Vascular, Inc.·May 21, 2025
Syntel Silicone Thrombectomy Catheter, Sterile, Rx Only. Used in vascular grafts and peripheral venous thrombectomies.
FDA Enforcement
Class II
·Ongoing·LeMaitre Vascular, Inc.·May 22, 2024
Glow 'N Tell 20 cm Tape: 1100-00 (100 strips); 1100-50 (50 strips); 1100-20 (20 strips). Intended to be placed on the skin to assist during imaging procedures.
FDA Enforcement
Class II
·Terminated·LeMaitre Vascular, Inc.·April 10, 2013
LeMaitre Single Lumen Embolectomy Catheter 3F, 80 cm, Model 1601-38 and e1601-38. Indicated for the removal of arterial emboli and thrombi.
FDA Enforcement
Class II
·Terminated·LeMaitre Vascular, Inc.·December 16, 2015
LeMaitre Over-the-Wire Embolectomy Catheter 5F Plus, 80cm, Model 1651-88 and e1654-88. Indicated for the removal of arterial emboli and thrombi.
FDA Enforcement
Class II
·Terminated·LeMaitre Vascular, Inc.·December 16, 2015
LeMaitre Over-the-Wire Embolectomy Catheter 7F, 80cm, Model 1654-78 and e1654-78. Indicated for the removal of arterial emboli and thrombi.
FDA Enforcement
Class II
·Terminated·LeMaitre Vascular, Inc.·December 16, 2015
LeMaitre Over-the-Wire Embolectomy Catheter 3F, 40cm, Model 1651-34 and e1651-34. Indicated for the removal of arterial emboli and thrombi.
FDA Enforcement
Class II
·Terminated·LeMaitre Vascular, Inc.·December 16, 2015
Anasto AC Closure System and Anasto Universal Clip Remover- Anasto AC 8cm 25 Clips (1 Each} X-Large REF # 4000-08 The Anastoclip Clip applier consists of a rotating shaft and an integral cartridge containing titanium clips. The Anastoclip Universal Clip Remover is intended to remove Anastoclip AC Clips as necessary. It is an accessory to the Anastoclip AC Clip Applier.
FDA Enforcement
Class II
·Terminated·LeMaitre Vascular, Inc.·August 3, 2016
LeMaitre NovaSil Silicone Single Lumen Embolectomy Catheter 2F, 60 cm, Model e1801-26. Indicated for the removal of arterial emboli and thrombi.
FDA Enforcement
Class II
·Terminated·LeMaitre Vascular, Inc.·December 16, 2015
LeMaitre Single Lumen Embolectomy Catheter 5F, 80 cm, Model 1601-58 and e1601-58. Indicated for the removal of arterial emboli and thrombi.
FDA Enforcement
Class II
·Terminated·LeMaitre Vascular, Inc.·December 16, 2015
LeMaitre Vascular Reddick Cholangiogram Catheter (eIFU) REF# e2400-50
FDA Enforcement
Class II
·Terminated·LeMaitre Vascular, Inc.·March 22, 2017
AnastoCiip Universal Clip Remover (1Each} REF# e4001-04 The Anastoclip Clip applier consists of a rotating shaft and an integral cartridge containing titanium clips. The Anastoclip Universal Clip Remover is intended to remove Anastoclip AC Clips as necessary. It is an accessory to the Anastoclip AC Clip Applier.
FDA Enforcement
Class II
·Terminated·LeMaitre Vascular, Inc.·August 3, 2016
AnastoClip AC 8cm 35 Clips (1 Each} Large REF # 4000-07 The Anastoclip Clip applier consists of a rotating shaft and an integral cartridge containing titanium clips. The Anastoclip Universal Clip Remover is intended to remove Anastoclip AC Clips as necessary. It is an accessory to the Anastoclip AC Clip Applier.
FDA Enforcement
Class II
·Terminated·LeMaitre Vascular, Inc.·August 3, 2016
Anastoclip AC 8cm 35 Clips (1 Each} Medium REF # 4000-06 The Anastoclip Clip applier consists of a rotating shaft and an integral cartridge containing titanium clips. The Anastoclip Universal Clip Remover is intended to remove Anastoclip AC Clips as necessary. It is an accessory to the Anastoclip AC Clip Applier.
FDA Enforcement
Class II
·Terminated·LeMaitre Vascular, Inc.·August 3, 2016
LeMaitre Vascular Reddick Cholangiogram Catheter with introducer(eIFU) REF # e2400-52
FDA Enforcement
Class II
·Terminated·LeMaitre Vascular, Inc.·March 22, 2017