BEUDAMED
    114 results · 19ms · 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 ×

    Measles IgG ELISA 96 Well Kit, Catalog Number: MS018G The products in question are all Enzyme Linked Immunosorbent Assay (ELISA) Test kits designed and marketed for Research Use Only.

    FDA Recall
    Terminated ·Calbiotech Inc·Product code LJB·August 27, 2008

    Measles IgM ELISA 96 Well Kit, Catalog Number: MS019M The products in question are all Enzyme Linked Immunosorbent Assay (ELISA) Test kits designed and marketed for Research Use Only.

    FDA Recall
    Terminated ·Calbiotech Inc·Product code LJB·August 27, 2008

    Measles IgG Enzyme Immunoassay Test Kit, DIAMEDIX. The assay is intended for the semi-quantitation of human IgG antibodies to measles virus in human serum by indirect immunoassay to aid in the assessment of the patient's immunological response to measles virus, to determine the immune status of individuals and, when evaluating paired sera, as an aid in the diagnosis of measles infection.

    FDA Recall
    Terminated ·Diamedix Corporation·Product code LJB·October 10, 2008

    VIDAS Measles IgG (MSG), REF 30219

    FDA Recall
    Open, Classified ·bioMerieux, Inc.·Product code LJB·September 22, 2021

    Brand Name: ReQuest Measles IgG Product Name: Rubeola IgG Enzyme Linked Immunoabsorbant Assay Model/Catalog Number: 01-190 Software Version: N/A Product Description: Measles IgG tests, performed using ELISA (Enzyme-Linked Immunosorbent Assay) method, used to detect the presence of IgG antibodies against measles virus in a patient's serum or plasma Component: not a component

    FDA Recall
    Open, Classified ·Quest International, Inc.·Product code LJB·October 1, 2025

    Measles (Rubeola) IgG ELISA Test System. It is an enzyme-linked immunosorbent assay (ELISA) designed for the qualitative detection of IgG antibodies to Measles (Rubeola) virus in human serum and is for in vitro diagnostic use. Product Number: 507055

    FDA Recall
    Terminated ·Zeus Scientific Inc·Product code LJB·March 19, 2001

    VIDAS CLINICAL VIDAS MEASLES IGG 60TESTS, CATALOG 30219

    FDA Recall
    Open, Classified ·Biomerieux Inc·Product code LJB·November 9, 2022

    ANSPACH - Fluted Ball; 9MM REF L-9B-G1 Cutting shaping bone including spine and cranium.

    FDA Recall
    Terminated ·The Anspach Effort, Inc.·Product code HBE·April 13, 2015

    Amvex Integrated Flowmeter; a nonback-pressure compensated Bourdon gauge flowmeter; Amvex Corporation, 25B East Pearce St, Richmond Hill, Ontario L4B 2M9, Canada; Model No. FI. The Integrated Flowmeter has two parts, the Outlet port and the Flowmeter port. The Outlet port is intended to be used as a standard wall Outlet, delivering a high flow of gas to secondary equipment. The Flowmeter port is intended to deliver a fixed flow of gas to patient or equipment.

    FDA Recall
    Terminated ·Amvex Corporation·Product code CCN·May 29, 2009

    Navigator System Surgical kit (SGKIT), handles inside of SGKIT Surgical Kit SGDPH1 through SGDPH5. The product is used for CT guided surgery.

    FDA Recall
    Terminated ·Biomet 3i, Inc.·Product code EJB·May 9, 2008

    Lenstar LS 900 EyeSuite Biometry version i2.000, Four (4) Protective Cardboard Containers Per Each System. Haag-Streit USA, Inc. A non-invasive, non-contact OLCR (Optical Low Coherence Reflectometer) Biometer used for obtaining ocular measurements and performing calculations to assist in determination of the appropriate power and type of IOL (Intraocular Lens) for implantation after removal of the natural crystalline lens following cataract removal.

    FDA Recall
    Terminated ·Haag-Streit USA Inc·Product code HJB·June 20, 2011

    Octopus 900 Perimeter, EyeSuite Perimetry version i4.000 (Flash v. 2.1.4 & 2.1.5), Model Number: Octopus 900, Distributed by: Haag-Streit USA, Inc., 3535 Kings Mills Rd., Mason, OH 45040 Product Usage: The OCTOPUS 900 Perimeter is designed for the examination, analysis and documentation of the field of sight, especially the light difference sensitivity and other functions of the human eye.

    FDA Recall
    Terminated ·Haag-Streit USA Inc·Product code HJB·November 14, 2011

    Adult Divided Cannula end tidal C)2 sampling w/male luer-lock connector. 7 ft, oxygen tube, 7 ft. CO2 tube RX only.For Single Patient Use only. Distributed by Tri-Anium Assembled in Mexico. Usage: Delivery of Anesthesia.

    FDA Recall
    Terminated ·SALTER LABS·Product code CCK·May 30, 2012

    Emission Computed Tomography System

    FDA Recall
    Terminated ·Adac Labs·Product code KPS·June 21, 2004

    Salter Labs EtCO2 Sample line 15' (4.6 M) tube, male luer connectors. Rx only; Made in Mexico; Manufacturer:Salter Labs, 100 West Sycamore Road, Arvin, CA 93203. CO2 sample line.

    FDA Recall
    Terminated ·SALTER LABS·Product code CCK·November 1, 2013

    GemStar I.V. Administration Pump Set with Orange Polyethylene-Lined Light Resistant Tubing, List Number: 13271

    FDA Recall
    Terminated ·Abbott Labs·Product code FRN·May 11, 2004

    ETCO2 Divided Sampling Cannula with Simultaneous Oxygen Delivery, Model number 4707 7-7-24. Salter Labs Nasal Cannula (Adult), Salter Style with modified nasal prongs. w/7' O2 line and 7' CO2 line with male luer lock connector. Salter Labs 100 W. Sycamore Road, Arvin, CA 93203

    FDA Recall
    Terminated ·SALTER LABS·Product code CCK·December 7, 2011

    Oxygen Mask, Model No. 8120-7 Product Usage: Oxygen Mask, High Concentration partial rebreather, with 7 foot (2.1 m) supply tube, Elastic Strap Fixation, Single patient use.

    FDA Recall
    Terminated ·Salter Labs·Product code BYG·June 25, 2014

    Temporary Titanium Abutments

    FDA Recall
    Open, Classified ·DDS Lab·Product code NHA·December 6, 2024

    Salter Labs Bubble humidifier, with 6 PSI safety valve, 350cc, Latex Free; Single Patient use; used with supplemental oxygen therapy. Model Numbers 7600-0-50, E7600-0-50, NP7600-0-50 and special order patient kits that contain 7600 humidifiers. Patient kits have brand names of Salter Labs, AdvaCare; Allcare Medical; Memorial Home Services; Therapy Support Inc; Mendo-Lake Home Respiratory Services; MedAssurance Inc.; Abundant Home Care. Product Usage: Humidifier - single patient use. used with supplemental oxygen therapy.

    FDA Recall
    Terminated ·SALTER LABS·Product code BBT·October 21, 2011