BEUDAMED
    47 results · 19ms · Sources: EU EUDAMED, US FDA

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    BBL DrySlide PYR Kit, catalog number 231747 Product Usage: Presumptive diagnostic aid for group A streptococci and group D enterococci bacteria.

    FDA Recall
    Terminated ·Becton Dickinson & Co. BD Diagnostic Systems·Product code JTO·April 12, 0013

    REF/Catalogue Number GSX0020A, GORE CARDIOFORM SEPTAL OCCLUDER 20 mm Diameter, Catheter Working Length 75 cm, Delivery Profile 10 Fr, STERILE EO, Rx Only, UDI: 00733132631018

    FDA Recall
    Open, Classified ·W L Gore & Associates, Inc.·Product code MLV·September 2, 2021

    REF/Catalogue Number GSX0030A, GORE CARDIOFORM SEPTAL OCCLUDER 30 mm Diameter, Catheter Working Length 75 cm, Delivery Profile 10 Fr, STERILE EO, Rx Only, UDI: 00733132631032

    FDA Recall
    Open, Classified ·W L Gore & Associates, Inc.·Product code MLV·September 2, 2021

    REF/Catalogue Number GSXE0020, GORE CARDIOFORM SEPTAL OCCLUDER 20 mm Diameter, Catheter Working Length 75 cm, Delivery Profile 10 Fr, STERILE EO, Rx Only, UDI: 00733132617630 *Not distributed within the US

    FDA Recall
    Open, Classified ·W L Gore & Associates, Inc.·Product code MLV·September 2, 2021

    REF/Catalogue Number GSXE0025, GORE CARDIOFORM SEPTAL OCCLUDER 25 mm Diameter, Catheter Working Length 75 cm, Delivery Profile 10 Fr, STERILE EO, Rx Only, UDI: 00733132617647 *Not distributed within the US

    FDA Recall
    Open, Classified ·W L Gore & Associates, Inc.·Product code MLV·September 2, 2021

    REF/Catalogue Number GSX0025A, GORE CARDIOFORM SEPTAL OCCLUDER 25 mm Diameter, Catheter Working Length 75 cm, Delivery Profile 10 Fr, STERILE EO, Rx Only, UDI: 00733132631025 *Not distributed within the US

    FDA Recall
    Open, Classified ·W L Gore & Associates, Inc.·Product code MLV·September 2, 2021

    REF/Catalogue Number GSXE0025B, GORE CARDIOFORM SEPTAL OCCLUDER 25 mm Diameter, Catheter Working Length 75 cm, Delivery Profile 10 Fr, STERILE EO, Rx Only, UDI: 00733132620111 *Not distributed within the US

    FDA Recall
    Open, Classified ·W L Gore & Associates, Inc.·Product code MLV·September 2, 2021

    REF/Catalogue Number GSXE0030B, GORE CARDIOFORM SEPTAL OCCLUDER 30 mm Diameter, Catheter Working Length 75 cm, Delivery Profile 10 Fr, STERILE EO, Rx Only, UDI: 00733132620128 *Not distributed within the US

    FDA Recall
    Open, Classified ·W L Gore & Associates, Inc.·Product code MLV·September 2, 2021

    REF/Catalogue Number GSX0030H, GORE CARDIOFORM SEPTAL OCCLUDER 30 mm Diameter, Catheter Working Length 75 cm, Delivery Profile 10 Fr, STERILE EO, Rx Only, UDI: 00733132648948 *Not distributed within the US

    FDA Recall
    Open, Classified ·W L Gore & Associates, Inc.·Product code MLV·September 2, 2021

    REF/Catalogue Number GSXE0030, GORE CARDIOFORM SEPTAL OCCLUDER 30 mm Diameter, Catheter Working Length 75 cm, Delivery Profile 10 Fr, STERILE EO, Rx Only, UDI: 00733132617661 *Not distributed within the US

    FDA Recall
    Open, Classified ·W L Gore & Associates, Inc.·Product code MLV·September 2, 2021

    CT Goldseal BrightSpeed 16 PWR TIO 2 YR

    FDA Recall
    Terminated ·GE Healthcare, LLC·Product code JAK·May 24, 2018

    RKN130002, RHEO KNEE 2 YR WARRANTY, MD, CE, External lower limb prosthetic component

    FDA Recall
    Open, Classified ·Ossur H F Grjothals 5 Reykjavik Iceland·Product code ISW·March 25, 2024

    RKN130003, RHEO KNEE 3 YR WARRANTY, MD, CE, External lower limb prosthetic component

    FDA Recall
    Open, Classified ·Ossur H F Grjothals 5 Reykjavik Iceland·Product code ISW·March 25, 2024

    RKNXC0003, RHEO KNEE XC 3 YR WARRANTY, MD, CE, External lower limb prosthetic component

    FDA Recall
    Open, Classified ·Ossur H F Grjothals 5 Reykjavik Iceland·Product code ISW·March 25, 2024

    Coloplast, Saline Filled Testicular Prosthesis, Sterile R, Manufacturer Coloplast A/S 3050 Denmark. Catalogue Number Description Part Number 450-1323 Extra Small 520600 450-1325 Small 520610 450-1327 Medium 520630 450-1329 Large 520650 The Coloplast Saline-Filled Testicular Prosthesis is intended for use when cosmetic testicular replacement is indicated i.e., in the case of agenesis or following the surgical removal of a testicle. The Butterfly Needle is used to fill the implant with saline.

    FDA Recall
    Terminated ·Coloplast Manufacturing US, LLC·Product code FAF·April 30, 2010

    VIDAS CLINICAL VIDAS HCG 60 TESTS, CATALOG 30405-01

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

    CellMek SPS Sample Preparation System, REF: C44603. Software versions 2.2.122.0 and prior, and Instructions for Use (IFU) revisions AD and prior. These CellMek devices include Cassette E.

    FDA Recall
    Open, Classified ·Beckman Coulter, Inc.·Product code PER·September 8, 2025

    BD FACS Sample Prep Assistant (SPA) II - Product Usage: K050191: The BD FACSCanto system with BD FACSCanto clinical software when used with the BD FACS Sample Prep Assistant II /III is intended for use as an in vitro diagnostic device for identification and enumeration of lymphocyte subsets in human cells in suspension using a lyse / no-wash sample preparation method for flow cytometry.

    FDA Recall
    Terminated ·Becton, Dickinson and Company, BD Biosciences·Product code PER·July 8, 2019

    Sysmex PS-10 Sample Preparation System Catalog number:BQ716341 - Product Usage: is a fully automated, user configurable, open system intended for use to prepare human specimens for subsequent analysis on flow cytometers.

    FDA Recall
    Terminated ·Sysmex America, Inc.·Product code PER·July 6, 2020

    Peptic Ulcer Test (H, pylori)

    FDA Recall
    Open, Classified ·GET TESTED INTERNATIONAL AB 59334 Vastervik Lysingsvagen 18 Vastervik Sweden·Product code LYR·November 3, 2025