BEUDAMED
    23 results · 15ms · 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 ×

    IG1, IGF-I reagent, Catalog # LKGF1; For the quantitative measurement of insulin-like growth factor I (IGF-I) in serum or heparinized plasma.

    FDA Recall
    Terminated ·Siemens Healthcare Diagnostics, Inc.·Product code CFL·April 15, 2016

    IGFBP-3 Immunoradiometric Assay (IRMA) Kit, Part Number: DSL-6600 usage: The DSL6600 IGFBP-3 immunoradiometric assay (IRMA) kit provides materials for the quantitative measurement of IGFBP-3 in serum. This assay is intended for in vitro diagnostic use.

    FDA Recall
    Terminated ·Beckman Coulter Inc.·Product code CFL·August 9, 2010

    cobas e801 Immunoassay Analyzer

    FDA Recall
    Open, Classified ·Roche Diagnostics Operations, Inc.·Product code JJE·July 14, 2022

    DuoDERM CGF Dressing 10x10CM (1x5PK) (ICC 187660) DuoDERM Extra Thin Dressing 15X15CM (1X10PK) (ICC 187957) DuoDERM Extra Thin Dressing 10X10CM (1X10PK) (ICC 187955)

    FDA Recall
    Open, Classified ·ConvaTec, Inc·Product code NAD·August 9, 2021

    GE Nuclear Medicine 600/800 series systems, specifically: a) BRIVO B615 3/8 inch DHP BJG NR, b) BRIVO 615 3/8 inch, c) BRIVO B615 3/8 inch DHP BJG NR, d) B615 with new rotor, e) BRIVO B615 3/8 inch BJG, f) BRIVO B615 3/8 inch DHP BJG NR, g) B615 with new rotor; Emission Computed Tomography System

    FDA Recall
    Open, Classified ·GE MEDICAL SYSTEMS ISRAEL, FUNCTIONAL IMAGING 4, Hayozma St Tirat Carmel Israel·Product code KPS·December 19, 2022

    Drop Arm Versamode"

    FDA Recall
    Terminated ·Gf Health Products·Product code ILS·March 24, 2021

    Nicolet Elite 3 MHz OB Probe, Model #: X1L001, Catalog Code: N300. Intended for non-invasive support, i.e. early detection of fetal life, monitor blood flow before and after surgery, etc.

    FDA Recall
    Terminated ·Natus Neurology Inc·Product code JAF·June 9, 2017

    Estrone RIA Catalog Number DSL8700 UDI Code: 15099590211615 Estrone RIA is an in vitro diagnostic manual medical device used by healthcare professionals for the quantitative measurement of estrone in human serum and plasma.

    FDA Recall
    Open, Classified ·Immunotech A.S. Radiova 1 Prague·Product code CGF·June 12, 2025

    Estrone RIA, REF: DSL8700. Estrone RIA is an IVD used for the quantitative measurement of estrone in human serum and plasma.

    FDA Recall
    Open, Classified ·Beckman Coulter Inc.·Product code CGF·June 12, 2025

    MultiLab Series II ROODRA non-invasive vascular diagnostic device, Model Number 11986-0000-01

    FDA Recall
    Open, Classified ·Unetixs Vascular, Inc.·Product code JAF·February 10, 2023

    MultiLab Series II LHS TI & ERGO non-invasive vascular diagnostic device, Model Number 11949-0000-01

    FDA Recall
    Open, Classified ·Unetixs Vascular, Inc.·Product code JAF·February 10, 2023

    MultiLab Series II REVO non-invasive vascular diagnostic device, Model Number 12950-0000-01

    FDA Recall
    Open, Classified ·Unetixs Vascular, Inc.·Product code JAF·February 10, 2023

    Estrone RIA, REF: DSL8700

    FDA Recall
    Open, Classified ·Immunotech A.S. Radiova 1 Prague·Product code CGF·December 15, 2025

    Estrone Radioimmunoassay (RIA) Kit, DSL-8700. Intended for in vitro diagnostic use.

    FDA Recall
    Terminated ·Beckman Coulter Inc.·Product code CGF·April 22, 2010

    Nicolet Elite 2 MHz OB Water Proof Probe, Model #: X1L008, Catalog Code: NW20. Intended for non-invasive support, i.e. early detection of fetal life, monitor blood flow before and after surgery, etc.

    FDA Recall
    Terminated ·Natus Neurology Inc·Product code JAF·June 9, 2017

    Nicolet Elite 2 MHz OB Probe, Non-Fetal Monitor, Model #: X1L007, Catalog Code: N200. Intended for non-invasive support, i.e. early detection of fetal life, monitor blood flow before and after surgery, etc.

    FDA Recall
    Terminated ·Natus Neurology Inc·Product code JAF·June 9, 2017

    Nicolet Elite 5 MHz Vascular Probe, Model #: X1L004, Catalog Code: N500. Intended for non-invasive support, i.e. early detection of fetal life, monitor blood flow before and after surgery, etc.

    FDA Recall
    Terminated ·Natus Neurology Inc·Product code JAF·June 9, 2017

    Pointe Scientific G6PD Controls Kit configuration: 6 x 0.5 ml (2 vials each of Level 1, Level 2 and Level 3). Also sold as individual vials Bottle: Clear glass vials Cap: Rubber seal with colored aluminum seals Glucose-6-phosphate dehydrogenase (G6PD) controls can be used to test for the quantitative and qualitative determination of G6PD in blood.

    FDA Recall
    Terminated ·Pointe Scientific, Inc.·Product code JBF·May 19, 2015

    MultiLab Series II 2CP & 2CP Express non-invasive vascular diagnostic device, Model Number 11996-0000-01

    FDA Recall
    Open, Classified ·Unetixs Vascular, Inc.·Product code JAF·February 10, 2023

    John Bunn 1392 Series Jackson Tracheostomy Stainless Steel Tube.

    FDA Recall
    Terminated ·Gf Health Products, Inc.·Product code BTO·September 14, 2009