BEUDAMED
    82 results · 13ms · Sources: EU EUDAMED, US FDA

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    Artis Q biplane with software VD12-angiography systems developed for single and biplane diagnostic imaging and interventional procedure Model Number: 10848282

    FDA Enforcement
    Class II ·Terminated·Siemens Medical Solutions USA, Inc·December 1, 2021

    UCG Slide Test; Rapid latex agglutination inhibition slide test for the detection of hCG in urine. Used in the diagnosis of pregnancy.

    FDA Recall
    Terminated ·Inverness Medical Professional Diagnostics·Product code LCX·February 12, 2010

    UCG Beta Slide Monoclonal II is a latex agglutination inhibition slide test for the detection of hCG in urine. This test is used for the diagnosis of pregnancy.

    FDA Recall
    Terminated ·Inverness Medical Professional Diagnostics·Product code LCX·February 12, 2010

    (1)Traverse Rail Carrier E-System, wide 31017XX component to Liko overhead lift, (2)Traverse Rail Carrier 31025XX component to Liko overhead lift. Intended for to make safe lifting of a patient possible. Affected Devices: 3101704 TRAV RAIL CARR E-SYST STD 3102514 TR CARRIER SLIM/RAISED, LR 3101705 TRAV RAIL CARR ESYST WIDE 3102517 TR CARR. NORMAL/LOWER. LR 3102506 TR CARRIER WIDE/RAISED ML 3102519 TR CARR. LOW.LR 30MM/PAIR 3102511 TR CARRIER NORMAL, LR 3102531 TRAVERSE RL CARRIER STD/RAISED 3102512 TR CARRIER WIDE, LR 3102532 TRAVERSE RL CARRIER WD/RAISED 3102513 TR CARRIER SLIM, LR 3102562 TR CARRIER, PARALLEL/WIDE

    FDA Enforcement
    Class II ·Terminated·Hill-Rom, Inc.·March 23, 2022

    Baxter HomeChoice Automated Peritoneal Dialysis Systems; Catalog Numbers: 5C4471, 5C4471R, 5C4474, 5C4474R, T5C4441, T5C4441R, 5C4474D and 5C447DR. The HomeChoice dialysis system is a personal cycler automated peritoneal dialysis system for pediatric and adult renal patients with fill volumes ranging from 60 mL to 3000 mL.

    FDA Recall
    Terminated ·Baxter Healthcare Renal Div·Product code FKX·January 8, 2010

    HomeChoice PRO Automated Peritoneal Dialysis Systems; Catalog Numbers; 5C8310, 5C8310R, R5C8320, R5C8320R, T5C8300, and T5C8300R. The HomeChoice dialysis system is a personal cycler automated peritoneal dialysis system for pediatric and adult renal patients with fill volumes ranging from 60 mL to 3000 mL. The HomeChoice PRO model has a PRO card, a small electronic data card, which stores information from the nurse or doctor and automatically sets up the system for the patient.

    FDA Recall
    Terminated ·Baxter Healthcare Renal Div·Product code FKX·January 8, 2010

    GreenLight HPS fiber optics, Model Number 10-2090, manufactured by AMS (American Medical Systems), San Jose, CA. Potentially Mislabeled as GreenLight PV 10-2079

    FDA Recall
    Terminated ·AMS Innovative Center San Jose·Product code GEX·January 22, 2010

    Hemashield Gold Woven and Knitted Double Vascular Grafts.

    FDA Recall
    Terminated ·Maquet Cardiovascular, LLC·Product code MAL·May 24, 2010

    Hemashield Platinum Woven Double Velour TAAA Vascular Grafts.

    FDA Recall
    Terminated ·Maquet Cardiovascular, LLC·Product code MAL·May 24, 2010

    Hemashield Gold Woven Double Velour Vascular Branch Graft

    FDA Recall
    Terminated ·Maquet Cardiovascular, LLC·Product code DSY·May 24, 2010

    Hemashield Double Velour Cardiovascular Fabrics.

    FDA Recall
    Terminated ·Maquet Cardiovascular, LLC·Product code DXZ·May 24, 2010

    Hemashield Finesse Ultra-thin Knitted Cardiovascular Patch.

    FDA Recall
    Terminated ·Maquet Cardiovascular, LLC·Product code DSZ·May 24, 2010

    Hemashield Platinum Woven and Knitted Double Velour Vascular Grafts.

    FDA Recall
    Terminated ·Maquet Cardiovascular, LLC·Product code MAL·May 24, 2010

    PKG, 5MM MULTI-FUNCTION PEEK HANDLE, P/N 0250181106 Laparoscopic Manual Instruments are intended for cutting, holding, grasping and manipulating of tissue, organs, organ areas and surgical auxiliaries such as suturing material. Some instruments have radio frequency (RF) ports which allow them to be used for electrosurgery. Laparoscopic surgical manual instruments are designed to be used endoscopically through cannulae to perform cutting, grasping, dissecting, retracting, and manipulating functions. This device does not sustain or support life.

    FDA Enforcement
    Class II ·Terminated·Stryker Endoscopy·December 24, 2014

    Medtronic 0-arm Imaging System with Software Version 3.1.1, Catalog Numbers: BI-700-00027-120R and BI-700-00027-120. The 0-arm Imaging System is a mobile x-ray system designed for 2D fluoroscopic and 3D imaging.

    FDA Recall
    Terminated ·Medtronic Navigation, Inc.·Product code IZL·October 12, 2010

    GE, 1011-9000-000 Aisys Anesthesia Machine and Monitor

    FDA Recall
    Terminated ·Ge Healthcare, Llc·Product code BSZ·March 12, 2010

    klinoPORT, AC powered Operating Table

    FDA Recall
    Terminated ·Kreuzer Gmbh & Co. KG BenzstraBe 26 Puchheim Germany·Product code FQO·October 26, 2010

    GE, 1009-9002-000 Avance Anesthesia Machine and Monitor

    FDA Recall
    Terminated ·Ge Healthcare, Llc·Product code BSZ·March 12, 2010

    NextGen Knee Gender Solutions CR-Flex Femoral Component, Precoat , Size D, Left. 00-5750-014-01 Zimmer, Inc. Warsaw, IN.

    FDA Recall
    Terminated ·Zimmer Inc.·Product code JWH·January 27, 2010

    Nova StatStrip Glucose Test Strips, Catalog Number: 42214. Nova Biomedical Corporation. Waltham, MA 02454. Intended for in vitro diagnostic use by health care professionals and for Point-Of-Care usage for the quantitative measurement of glucose in capillary, venous, arterial and neonate whole blood.

    FDA Recall
    Terminated ·Nova Biomedical Corporation·Product code CGA·February 12, 2010