BEUDAMED
    31 results · 11ms · 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: Terminated ×

    iQ200 Series Urine Microscopy Analyzer, Catalog numbers: 700-3345, 700-3375, 700-3325, 700-3347, 700-3300RFB, 700- 3320, 700-3320RFB, 700-3322, 700-3322RFB, 700-3326, 700- 3340, 700-3370, B48999, C10683, C10684 - Product Usage: device used to automate the complete urinalysis profile, including urine test strip chemistry panel and microscopic sediment analysis.

    FDA Recall
    Terminated ·Beckman Coulter Inc.·Product code LKM·October 28, 2019

    The UF-1000i is a fully automated urine particle analyzer intended for vitro diagnostic use in urinalysis. The instrument can perform screening for abnormal samples with a high degree of accuracy, so it increases automation and efficiency in laboratories.

    FDA Recall
    Terminated ·Sysmex America, Inc.·Product code LKM·March 31, 2013

    Helion and Xenion surgical lights, 501/01 series KLM lights. The surgical lights are intended to locally illuminate an operating or examination area of the patients body with a high intensity light.

    FDA Recall
    Terminated ·Trumpf Medical Systems, Inc.·Product code FSY·September 19, 2012

    Syn go Imaging XS is a picture archiving and communication system intended to display, process, read, report, communicate, distribute, store and archive digital radiological images, including digital mammography images.

    FDA Recall
    Terminated ·Siemens Medical Solutions USA, Inc·Product code LLZ·March 10, 2008

    Helion and Xenion surgical lights, 501/01 series KLM lights. The surgical lights are intended to locally illuminate an operating or examination area of the patients body with a high intensity light.

    FDA Enforcement
    Class II ·Terminated·Trumpf Medical Systems, Inc.·October 24, 2012

    Abbott TDx/TDxFLx Gentamicin Reagent - Is a reagent for in vitro diagnostic use. This reagent system is composed of one bottle of gentamicin antiserum, one bottle of gentamicin flourescein tracer and one bottle of pretreatment solution. Abbott Laboratories, Abbott Park, IL 60064

    FDA Recall
    Terminated ·Abbott Diagnostic International, Ltd. Carr # 2 Km 58.0 Cruce Davila·Product code LCQ·October 26, 2007

    Abbott Diagnostic International, Ltd.-- AxSYM Digoxin III Reagent Pack, List (6L07-20), For In Vitro Diagnostic use. This reagent system is composed of one bottle of Digoxin-Alkaline Phosphatase Conjugate, one bottle of Anti-Digoxin (Rabbit) Coated microparticles, one bottle of MEIA buffer, and one bottle of Digoxin Probe wash solution.

    FDA Recall
    Terminated ·Abbott Diagnostic International, Ltd. Carr # 2 Km 58.0 Cruce Davila·Product code KXT·July 20, 2007

    In vitro Test TDx/TDxFLx Cyclosporine Monoclonal Whole Blood Reagent Pack 100 test TDx/TDxFLx Cyclosporine Monoclonal Whole Blood Calibrators are composed of six vials of calibrators A, B, C, D, E, and F containing cyclosporine prepared in human blood component (non-reactive for HBxAg, anti-HCv, anti-HIV-1/HIV-20. TDx/TDxFLx Cyclosporine Monoclonal Whole Blood Controls are composed of three vials L, M and H containing cyclosporine in human blood componenet (nonreactive for HBsAg, anti-HCV, and anti-HIV-1/HIV-2).

    FDA Recall
    Terminated ·Abbott Health Products, Inc. Hwy 2 Km 58.0 Cruze Davila·Product code MGU·March 23, 2005

    Abbott AxSYM Matrix Cells--Product List No: 8A73-02, sold in boxes of 100

    FDA Recall
    Terminated ·Abbott Diagnostic International, Ltd. Carr 2 Km 58.0 Cruce Davila·Product code JJE·September 8, 2006

    AxSYM Ultrasensitive hTSH II Master Calibrators Microparticle Enzyme Immunoassay that determines amount of human thyroid stimulating hormone in human serum and plasma.

    FDA Recall
    Terminated ·Abbott Diagnostic International, Ltd. Carr # 2 Km 58.0 Cruce Davila·Product code JIS·March 6, 2008

    Abbott AxSYM system FSH Master Calibrators (LN 7A60-30), for in vitro diagnostic use.

    FDA Recall
    Terminated ·Abbott Diagnostic International, Ltd. Carr 2 Km 58.0 Cruce Davila·Product code JIS·September 7, 2006

    Abbott TDx/TDxFLx Gentamicin Wedge Reagent - Is a reagent for in vitro diagnostic use. This reagent system is composed of one bottle of gentamicin antiserum, one bottle of gentamicin flourescein tracer and one bottle of pretreatment solution. Abbott Laboratories, Abbott Park, IL 60064

    FDA Recall
    Terminated ·Abbott Diagnostic International, Ltd. Carr # 2 Km 58.0 Cruce Davila·Product code LCQ·October 26, 2007

    FSH Calibrators (LN 9C06-01), for in vitro diagnostic use.

    FDA Recall
    Terminated ·Abbott Diagnostic International, Ltd. Carr 2 Km 58.0 Cruce Davila·Product code JIT·September 7, 2006

    Architect FSH Calibrators (LN 6C24-01), for in vitro diagnostic use.

    FDA Recall
    Terminated ·Abbott Diagnostic International, Ltd. Carr 2 Km 58.0 Cruce Davila·Product code JIT·September 7, 2006

    Abbott AxSYM Gentamicin Reagent - Is a reagent for in vitro diagnostic use. This reagent system is composed of one bottle of gentamicin antiserum, one bottle of pretreatment solution and one bottle of gentamicin flourescein tracer. Abbott Laboratories, Abbott Park, IL 60064

    FDA Recall
    Terminated ·Abbott Diagnostic International, Ltd. Carr # 2 Km 58.0 Cruce Davila·Product code LCD·October 26, 2007

    ARCHITECT HAVAB-M Reagent A chemiluminescent microparticle immunoassay (CMIA) for the qualitative detection of IgM antibody to hepatitis A virus (IgM anti-HAV) in human adult and pediatric serum and plasma (dipotassium EDTA, lithium heparin, and sodium heparin) and neonatal serum.

    FDA Recall
    Terminated ·Abbott Diagnostics International, Ltd. Carr # 2 Km 58.0 Cruce Davila·Product code LOL·December 30, 2009

    AxSYM Digoxin II Reagent Pack, Disk Version 1. (3D53-01 or 3D53-02) The AxSYM Digoxin II assay is a Microparticle Enzyme Immunoassay (MEIA) for the quantitative measurement of digoxin, a cardiovascular drug, in serum or plasma. The measurements obtained are used in the treatment of digoxin overdose and monitoring levels of digoxin to ensure appropriate therapy.

    FDA Recall
    Terminated ·Abbott Diagnostic International, Ltd. Carr # 2 Km 58.0 Cruce Davila·Product code KXT·May 22, 2008

    Southmedic/Personna Safety Scalpel with Personna Plus Blades, Reorder No. 73-0615, Size #15, General Surgical Use, Sterile, unless package is damaged or opened., Southmedic Inc., 50 Alliance Blvd., Barrie, ON., Canada L4M 5K3 www.southmedic.com, Made in Canada.

    FDA Recall
    Terminated ·Southmedic, Inc. 50 Alliance Blvd. Barrie Canada Ontario·Product code GDX·September 3, 2010

    Southmedic/Personna Safety Scalpel with Personna Plus Blades, Reorder No. 73-0610, Size #10, General Surgical Use, Sterile, unless package is damaged or opened., Southmedic Inc., 50 Alliance Blvd., Barrie, ON., Canada L4M 5K3 www.southmedic.com, Made in Canada.

    FDA Recall
    Terminated ·Southmedic, Inc. 50 Alliance Blvd. Barrie Canada Ontario·Product code GDX·September 3, 2010

    Southmedic/Personna Safety Scalpel with Personna Plus Blades, Reorder No. 73-0611, Size #11, General Surgical Use, Sterile, unless package is damaged or opened., Southmedic Inc., 50 Alliance Blvd., Barrie, ON., Canada L4M 5K3 www.southmedic.com, Made in Canada.

    FDA Recall
    Terminated ·Southmedic, Inc. 50 Alliance Blvd. Barrie Canada Ontario·Product code GDX·September 3, 2010