12 results
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13ms
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Sources: EU EUDAMED, US FDA
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Status: Open, Classified
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Blinq Pediatric Vision Scanner-Pediatric Vision Scanner-intended for automated detection of misalignment of the visual axes using polarized light. Model Number BQ830
FDA Recall
Open, Classified
·Rebiscan, Inc.·Product code PMW·October 3, 2022
syngo Application software VE20 (Material Number 10848815) installed on the Artis pheno and Artis icono systems as follows: (1) Artis pheno Model Number:10849000 (2) Artis icono biplane Model Number: 11327600 (3) Artis icono floor Model Number: 11327700
FDA Recall
Open, Classified
·Siemens Medical Solutions USA, Inc·Product code OWB·February 25, 2022
Syntel Silicone Thrombectomy Catheter, Sterile, Rx Only. Used in vascular grafts and peripheral venous thrombectomies.
FDA Recall
Open, Classified
·LeMaitre Vascular, Inc.·Product code DXE·April 17, 2024
LeMaitre 5F Plus Over the Wire Embolectomy Catheter, Model Nos. 1651-84, e1651-84, 1651-88, e1651-88. The LeMaitre Over the Wire Embolectomy Catheter is indicated for use in the removal of emboli and thrombi during embolectomy and/or thrombectomy. It can also be used for catheter placement over a guidewire, vessel occlusion, fluid infusion and/or aspiration.
FDA Recall
Open, Classified
·LeMaitre Vascular, Inc.·Product code DXE·March 23, 2020
Multi-Snare Set: 5 mm x 125 cm, REF: 147305; 10 mm x 125 cm, REF: 147310
FDA Recall
Open, Classified
·PFM MEDICAL INC.·Product code DXE·April 21, 2026
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 Recall
Open, Classified
·LeMaitre Vascular, Inc.·Product code DXE·April 11, 2025
Fogarty Biliary Balloon Probes Model Number: 410235FP 410405FP 410236FP
FDA Recall
Open, Classified
·Edwards Lifesciences, LLC·Product code DXE·October 6, 2022
eakin Cohesive seal, small, Model Number 839002, ostomy barrier seal
FDA Recall
Open, Classified
·T.G. Eakin Limited·Product code EXE·August 8, 2024
Fogarty Thru-Lumen Embolectomy Catheter, REF: 12TLW805F35
FDA Recall
Open, Classified
·Edwards Lifesciences, LLC·Product code DXE·September 7, 2023
Esteem Synergy Stomahesive Skin Barrier, part of Esteem synergy, which is a two-piece ostomy system consisting of an adhesive skin barrier and an adhesive pouch: ESTEEM SYN FLX WHT16/35MM PRECUT(1X10), REF: 405473; ESTEEM SYN FLX WHT35/35MM PRECUT(1X10), REF: 405479
FDA Recall
Open, Classified
·ConvaTec, Inc·Product code EXE·November 29, 2024
TufTex Embolectomy Catheter, Model No. This catheter has a latex balloon and a single lumen extrusion. It is inserted using a guidewire or introducer. The devices affected by this recall are 3F and 4F..
FDA Recall
Open, Classified
·LeMaitre Vascular, Inc.·Product code DXE·September 30, 2022
Fogarty Arterial Embolectomy Catheters Model Number: 120602FP 120403FP 120803FP 120404FP 120804FP 120805FP 120806FP 120807FP Fogarty Arterial Embolectomy Catheter with Stylet Model Number: 120403FSP 120803FSP
FDA Recall
Open, Classified
·Edwards Lifesciences, LLC·Product code DXE·October 6, 2022