BEUDAMED
    371 results · 26ms · Sources: EU EUDAMED, US FDA

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    Alere Cholestech LDX Multianalyte Controls, PN 88769 and 88773. Enables users to monitor the performance of total cholesterol (TC), high density lipoprotein cholesterol (HDL), triglycerides (TRG) and glucose (GLU) test procedures.

    FDA Recall
    Terminated ·Alere San Diego, Inc.·Product code JJY·August 27, 2015

    Alere Triage CardioProfiler Panel, PN 97100CP. The test is used as an aid in the diagnosis of myocardial infarction (injury), an aid in the diagnosis and assessment of severity of congestive heart failure, an aid in the risk stratification of patients with heart failure, and as an aid in the risk stratification of patients with acute coronary syndromes.

    FDA Recall
    Terminated ·Alere San Diego·Product code MMI·March 5, 2012

    Alere Triage Profiler SOB Panel, PN 97300. The test is used as an aid in the diagnosis of myocardial infarction (injury), an aid in the diagnosis and assessment of severity of heart failure, an aid in the risk stratification of patients with heart failure, an aid in the assessment and evaluation of patients suspected of having disseminated intravascular coagulation or thromboembolic events including pulmonary embolism and an aid in the risk stratification of patients with acute coronary syndromes.

    FDA Recall
    Terminated ·Alere San Diego·Product code MMI·March 5, 2012

    Alere Cholestech LDX ALT AST Test Cassette, Model #12-788. For the in vitro quantitative determination of alanine aminotransferase (ALT) and aspartate aminotransferase (AST).

    FDA Recall
    Terminated ·Alere San Diego, Inc.·Product code CKD·March 6, 2013

    Alere Triage BNP Calibrators for the Beckman Coulter Access Family of Immunoassay Systems, Model No. 98202 The Alere Triage BNP test is intended for use with the Beckman Coulter Access Family of Immunoassay Systems for the In Vitro quantitative measurement of B-type natriuretic peptide (BNP) in plasma specimens using EDTA as the anticoagulant. The test is intended to be used for the following indications: as an aid in the diagnosis of congestive heart failure (also referred to as heart failure) as an aid in the assessment of severity of congestive heart failure for the risk stratification of patients with acute coronary syndromes for the risk stratification of patients with heart failure The Alere Triage BNP Calibrators are intended to calibrate the Alere Triage BNP test for the quantitative determination of BNP levels in human EDTA plasma using the Beckman Coulter Access Family of Immunoassay Systems.

    FDA Recall
    Terminated ·Alere San Diego, Inc.·Product code NBC·May 30, 2014

    Stainless Steel, Natural, Upper, .018": Arch Wires. Highland Metals, San Jose, CA 95125

    FDA Recall
    Terminated ·Highland Metals·Product code D·January 7, 2008

    Pyxis Anesthesia System 3500, Cardinal Health, Clinical Technologies and Services, San Diego, CA

    FDA Recall
    Terminated ·Cardinal Health 303 Inc DBA Alaris Products·Product code BRY·August 13, 2007

    Stainless Steel, Natural, Lower, .018": Arch Wires. Highland Metals, San Jose, CA 95125

    FDA Recall
    Terminated ·Highland Metals·Product code D·January 7, 2008

    Stryker ACL Workstation slider, Model Number: 234-010-503, Stryker, San Jose, CA 95138

    FDA Recall
    Terminated ·Stryker Endoscopy·Product code HRX·December 7, 2007

    Burke Bariatric Bed, manufactured by Kinetic Concepts, Inc., San Antonio, TX, model number 7064

    FDA Recall
    Terminated ·Kinetic Concepts, Inc·Product code FNL·March 22, 2004

    Stryker Infravision Esophageal Kit, Model Numbers 220180548, 220180540, 220180560, manufactured by Stryker Endoscopy San Jose.

    FDA Recall
    Terminated ·Stryker Endoscopy·Product code FAT·August 20, 2009

    RotoProne powered patient rotation bed, part #209500, distributed by Kinetic Concepts, Inc., San Antonio, TX.

    FDA Recall
    Terminated ·Kinetic Concepts, Inc·Product code IKZ·January 24, 2005

    Triage Micro ClostrIdium difficile (C.difficile) Panel, Catalog No: 96000, BIOSITE INCORPORATED, San Diego, CA 92121

    FDA Recall
    Terminated ·Biosite Inc·Product code MCB·December 4, 2007

    Stainless Steel, Natural,Lower, .016 x.022: Arch Wires. Highland Metals, San Jose, CA 95125

    FDA Recall
    Terminated ·Highland Metals·Product code D·January 7, 2008

    Stryker Endoscopy PrepStrap Shoulder Sleeve, Model Number 3910900200, Manufactured by Stryker Endoscopy, San Jose, CA

    FDA Recall
    Terminated ·Stryker Endoscopy·Product code HST·July 27, 2009

    KinAir MedSurg, flotation therapy, powered hospital bed, manufactured by Kinetic Concepts, Inc., San Antonio, Texas

    FDA Recall
    Terminated ·Kinetic Concepts, Inc·Product code IOQ·June 6, 2003

    Invictus-- Bionime Rightest Blood Glucose Monitoring System MODEL: GM300; Invictus Scientific, Inc., San Diego, CA

    FDA Recall
    Terminated ·Invictus Scientific Inc·Product code NBW·November 26, 2007

    VNUS ClosureFAST catheters, Model Number: CL7-7-100, VNUS Medical Technologies, Inc., San Jose, CA 95138

    FDA Recall
    Terminated ·VNUS Medical Technologies Inc·Product code GEI·March 6, 2007

    22G Nerve Block PainPak, Reorder No.:3269, kit manufactured by Integra Spinal Specialties, San Antonio, Texas.

    FDA Recall
    Terminated ·Spinal Specialties, Inc·Product code CAZ·April 15, 2005

    Boston Scientific SteeroCath-Dx Diagnostic Catheter, Manufactured by Boston Scientific Corporation, San Jose, CA - Cardiac Catheter

    FDA Recall
    Terminated ·Boston Scientific Corp·Product code DRF·February 14, 2008