BEUDAMED
    453 results · 14ms · Sources: EU EUDAMED, US FDA

    Get notified when this changes

    We'll email you when new records match this search — new devices, new clearances, certificate changes, or withdrawals.
    Filters Status: Open, Classified ×

    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

    Universal Viewer Workflow Manager, Image processing radiological system

    FDA Recall
    Open, Classified ·GE Healthcare·Product code LLZ·September 8, 2023

    Centricity Universal Viewer, Centricity Universal Viewer 6.0, Model/Catalog Numbers: a) 2088026-003, b) 2088026-026, c) 2088026-032, d) 2088026-043, e) 2088026-044, f) 2088026-115, g) 2088026-132, h) 2088026-306, i) 2088026-308, j) 2088026-406, k) 2088026-506, l) 2088026-613, m) 2088026-713, n) 2088026-714, o) 2088026-723, p) 2099714-001, q) 2100169-001, r) 2100491-006, s) 2102675-010, t) 2102676-001, u) 2104867-044, v) 2104867-045; Radiological Image Processing System

    FDA Recall
    Open, Classified ·GE Healthcare·Product code LLZ·March 28, 2023

    GE Healthcare Centricity PACS-IW (PACS-IW), Model Numbers: 1) 2042988-001; 2) 2049587-009; 3) 2049587-011; 4) 2049587-012; 5) 2049587-015; 6) 2049588-012 ; 7) 2052829-001.

    FDA Recall
    Open, Classified ·GE Healthcare·Product code LLZ·February 19, 2025

    GE Healthcare Centricity Centricity PACS-IW with Universal Viewer, Model Numbers: 1) 2049587-015; 2) 2066908-086; 3) 2066908-136; 4) 2104867-045.

    FDA Recall
    Open, Classified ·GE Healthcare·Product code LLZ·February 19, 2025

    GE Healthcare Centricity Universal Viewer Zero Footprint, Model Numbers: 1) 2089507-083, GDZH-JINWAN-Centricity 2) 2089507-093, 10510-3-Centricity Universal Viewer Zero Footprint / ZFP-02268286, 10510-3-Centricity Universal Viewer Zero Footprint / ZFP-02030900, 1495-1-Centricity Universal Viewer Zero Footprint / ZFP-02347996, 423834-Centricity Universal Viewer Zero Footprint / ZFP-02286658, 1407636-Centricity Universal Viewer Zero Footprint / ZFP-02304121, 651240-Centricity Universal Viewer Zero Footprint / ZFP-02173181, 268034-Centricity Universal Viewer Zero Footprint / ZFP-02402520; 3) 2089507-098, JP-310027-Centricity Universal Viewer Zero Footprint / ZFP-02033125; 4) 2089507-109, 3909-2-Centricity Universal Viewer Zero Footprint / ZFP-20095312, 3909-2-Centricity Universal Viewer Zero Footprint / ZFP-20095313, 327750-Centricity Universal Viewer Zero Footprint / ZFP-02184508; 5) 2089507-111, 105468-1-Centricity Universal Viewer Zero Footprint / ZFP-02254840, 1495-3-Centricity Universal Viewer Zero Footprint / ZFP-00096090, JP-340111-Centricity Universal Viewer Zero Footprint / ZFP-01275379, JP-275353-Centricity Universal Viewer Zero Footprint / ZFP-02042636; 6) 2089507-112, 3922-25-Centricity Universal Viewer Zero Footprint / ZFP-01290685, 3922-17-Centricity Universal Viewer Zero Footprint / ZFP-00098229, 1503586-Centricity Universal Viewer Zero Footprint / ZFP-21016603, RU0994-Centricity Universal Viewer Zero Footprint / ZFP-02331255; 7) 2089507-114, 1461-1-Centricity Universal Viewer Zero Footprint / ZFP-02360229, 1461-1-Centricity Universal Viewer Zero Footprint / ZFP-01803680, 3728-2-Centricity Universal Viewer Zero Footprint / ZFP-01225897, 3728-2-Centricity Universal Viewer Zero Footprint / ZFP-01225898, 3728-2-Centricity Universal Viewer Zero Footprint / ZFP-01225904, 3728-2-Centricity Universal Viewer Zero Footprint / ZFP-01371500, M51725-Centricity Universal Viewer Zero Footprint / ZFP-01300873, M1781854-Centricity Universal Viewer Zero Footprint / ZFP-01553772, 609334-Centricity Universal Viewer Zero Footprint / ZFP-01282257, UJJF01-Centricity Universal Viewer Zero Footprint / ZFP-22186138, CMC-Centricity Universal Viewer Zero Footprint / ZFP-01820241, JP-100014-Centricity Universal Viewer Zero Footprint / ZFP-01890709, KW1102-Centricity Universal Viewer Zero Footprint / ZFP-02191178, 59219_ERPerror-Centricity Universal Viewer Zero Footprint / ZFP-02327073, QA1114-Centricity Universal Viewer Zero Footprint / ZFP-02306397, SAU1433-Centricity Universal Viewer Zero Footprint / ZFP-01457278, TTSH-CVIS-Centricity Universal Viewer Zero Footprint / ZFP-02041523, NE4651-Centricity Universal Viewer Zero Footprint / ZFP-00038599, NE6703-Centricity Universal Viewer Zero Footprint / ZFP-00038552, NE6731-Centricity Universal Viewer Zero Footprint / ZFP-00038461, NE3006-Centricity Universal Viewer Zero Footprint / ZFP-00038362, NE2196-Centricity Universal Viewer Zero Footprint / ZFP-00038588, NPV738-Centricity Universal Viewer Zero Footprint / ZFP-00038637, NE2031-Centricity Universal Viewer Zero Footprint / ZFP-00038578, NE7405-Centricity Universal Viewer Zero Footprint / ZFP-00038372, NE2162-Centricity Universal Viewer Zero Footprint / ZFP-00038563, NE4878-

    FDA Recall
    Open, Classified ·GE Healthcare·Product code LLZ·October 3, 2024

    GE Healthcare Centricity Cardiology CA1000 (CA1000), Model Numbers: 1) 2033901-001; 2) 2038437-001; 3) 2038437-009; 4) 2038437-014; 5) 2038437-015 ; 6) 2038437-0XX; 7) 2109571-007; 8) 2109571-010; 9) 2109571-011; 10) 2109571-012; 11) MANLEGACY111; 12) MANLEGACY112; 13) MANLEGACY47; 14) P00011TS.

    FDA Recall
    Open, Classified ·GE Healthcare·Product code LLZ·February 19, 2025

    GE Healthcare Centricity Universal Viewer Zero Footprint Client, Model Numbers: 2110344-039, 2110344-046, 2110344-047; System, Image Processing, Radiological

    FDA Recall
    Open, Classified ·GE Healthcare·Product code LLZ·January 16, 2026

    Centricity PACS-IW, software versions V3.7.x through 3.7.3.9 SP3; Radiological Image Processing System

    FDA Recall
    Open, Classified ·GE Healthcare·Product code LLZ·September 14, 2023