BEUDAMED
    36 results · 27ms · 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 FDA Recall ×

    Restoration #8 HA Hip Stem, Catalog No. 6013-1216 and Restoration #8 HA Hip Stem, Catalog No. 6013-1218.

    FDA Recall
    Terminated ·Stryker Howmedica Osteonics·Product code MEH·December 2, 2002

    Apex Arc Hip Stem, Size 2, HA Coated; Product Code: HC-21002-HA

    FDA Recall
    Terminated ·Omnilife Science Inc.·Product code LZO·May 9, 2014

    IDkit:HP" Breath Test for Detection of H. pylori, Manufactured by: Exalenz Bioscience Ltd 4 Ha' maayan St. Modiin, Israel 71700, Distributed by: Exalenz Bioscience Inc., 1313 N. Market St., Sute 5100, Wilmington, DE 19808 USA Product Usage: The IDkit:HP Two Test System is intended for use in the qualitative detection of urease associated with Helicobacter pylori in the human stomach and as an aid in initial diagnosis and post treatment monitoring of H. pylori infection in adult patients. Urea Breath Tests are well established as reliable, non-invasive methods for detecting H. pylori. They are highly endorsed by various medical societies as the test of choice for initial detection as well as for post-treatment testing.

    FDA Recall
    Terminated ·Exalenz Bioscience Ltd Hamaayan 4 Modiin Israel·Product code MSQ·June 7, 2011

    Strauss Penis Clamp 130MM/General Instruments

    FDA Recall
    Terminated ·Aesculap Implant Systems LLC·Product code FHA·February 16, 2018

    Acuson Diagnostic Ultrasound System Transducer; Model Number(s): L582 Linear Array Transducer for use on the 128XP Ultrasound System; Catalog Numbers: 23656 (New), 45441 (Refurb)

    FDA Recall
    Terminated ·Siemens Medical Solutions USA, Inc.·Product code MAA·March 31, 2003

    Stratus CS STAT Fluorometric Analyzer BHCG DilPak (CBHCG-D) in vitro diagnostic.

    FDA Recall
    Terminated ·Dade Behring Inc.·Product code DHA·April 3, 2006

    Product is a handheld fetal Doppler used to screen for fetal heart rate and averaged fetal heart rate and is labeled as: Sonotrax Handheld Fetal Doppler Series and includes the Basic and Lite models.

    FDA Recall
    Terminated ·Danatech Medical Systems Inc·Product code MAA·December 5, 2003

    Immulite 2500 Automated Immunoassay Analyzer, Human chorionic gonadotrpin (HCG) test system.

    FDA Recall
    Terminated ·DPC Cirrus·Product code DHA·October 29, 2004

    Acuson Diagnostic Ultrasound System Transducer; Model Number(s): L582 Linear Array Transducer for use on the 128XP Ultrasound System; Catalog Numbers: 23656 (New), 45441 (Refurb)

    FDA Recall
    Terminated ·Siemens Medical Solutions USA, Inc.·Product code MAA·March 31, 2003

    Siemens Acute Care BHCG TestPak-an in vitro diagnostic product intended to be used for calibration of the Stratus CS Acute Care hCG method Catalog Number: CBHCG SMN:10445060

    FDA Recall
    Terminated ·Siemens Healthcare Diagnostics Inc·Product code DHA·November 11, 2015

    Stratus CS STAT Fluorometric Analyzer BHCG TestPak (CBHCG) in vitro diagnostic.

    FDA Recall
    Terminated ·Dade Behring Inc.·Product code DHA·April 3, 2006

    Visual hCG ELISA kit BioCheck, Foster City, CA 9440. Quantitative determination of AFP concentration in human serum.

    FDA Recall
    Terminated ·BioCheck Inc·Product code DHA·December 22, 2010

    1) VITROS Immunodiagnostic Products Total Beta-hCG II Reagent Pack (Unique Device Identifier No. 10758750002320, 20758750002327) and the 2)VITROS Immunodiagnostic Products Total Beta-hCG II Calibrators (Unique Device Identifier No. 10758750002337, 20758750002334); For quantitative measurement of human chorionic gonadotropin (hCG) and its beta subunit in human serum and plasma.

    FDA Recall
    Terminated ·Ortho-Clinical Diagnostics·Product code DHA·February 18, 2016

    ST-AIA PACK HCG; Part Number: 025256 Assay, Reproductive Hormone

    FDA Recall
    Terminated ·Tosoh Bioscience Inc·Product code DHA·March 5, 2018

    Nichols Advantage Invasive Trophoblast Antigen (ITA)Assay Cartridges (Catalog #62-7052)

    FDA Recall
    Terminated ·Nichols Institute Diagnostics·Product code DHA·August 31, 2005

    Hyperglycosylated Human Chorionic Gonadotropin (H-hCG) Assay Cartridges (Catalog#62-7039)

    FDA Recall
    Terminated ·Nichols Institute Diagnostics·Product code DHA·August 31, 2005

    Alinity i Total Beta-hCG Reagent Kit, List Number 07P5121

    FDA Recall
    Terminated ·Abbott Ireland Diagnostics Division Lisnamuck Co. Longford Ireland·Product code DHA·November 21, 2018

    Alinity Reaction Vessels, REF: 06P1401, for use with Alinity i Systems; ARCHITECT Reaction Vessels

    FDA Recall
    Open, Classified ·Abbott Laboratories·Product code DHA·November 24, 2022

    IMMULITE 2000 Systems HCG [200 Tests, material number 10381206, catalog number L2KCG] and [600 Tests, material number 10381194, catalog number L2KCG6]

    FDA Recall
    Open, Classified ·Siemens Healthcare Diagnostics, Inc.·Product code DHA·February 22, 2022

    Free beta-hCG ELISA kit BioCheck, Foster City, CA 9440. Quantitative determination of AFP concentration in human serum.

    FDA Recall
    Terminated ·BioCheck Inc·Product code DHA·December 22, 2010