BEUDAMED
    48 results · 26ms · 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 Country: France ×

    Graftys

    Manufacturer
    🇫🇷 France·4 Basic UDI-DIs·4 Devices·National Standards Authority of Ireland (NSAI) and National Standards Authority of Ireland (NSAI)

    GRAFTYS HBS

    Device
    EU MDD · Eu Md Class 3 ·Graftys·On the market·1 country

    GRAFTYS HBS

    Device
    EU MDD · Eu Md Class 3 ·Graftys·On the market·1 country

    GRAFTYS HBS

    Device
    EU MDD · Eu Md Class 3 ·Graftys·On the market·1 country

    GRAFYS DELIVERING GUN

    Device
    EU MDD · Eu Md Class 1 ·Graftys·On the market·26 countries

    GRAFTYS HBS

    Basic UDI-DI
    EU MDD · Eu Md Class 3 ·Graftys·1 device

    GRAFTYS HBS

    Basic UDI-DI
    EU MDD · Eu Md Class 3 ·Graftys·1 device

    GRAFTYS HBS

    Basic UDI-DI
    EU MDD · Eu Md Class 3 ·Graftys·1 device

    GRAFTYS Delivering Gun

    Basic UDI-DI
    EU MDD · Eu Md Class 1 ·Graftys·1 device

    252.798

    Certificate
    MDD Annex II Section 4·Graftys·National Standards Authority of Ireland (NSAI)·3 Basic UDI-DIs

    252.799

    Certificate
    MDD Annex V·Graftys·National Standards Authority of Ireland (NSAI)·1 Basic UDI-DI

    Blueprint Software, BPUE001. Intended for use by surgeons as a pre surgical planner for shoulder replacement.

    FDA Enforcement
    Class II ·Ongoing·Tornier S.A.S.·May 14, 2025

    IMPIX ALIF S/A, REF number B15241415; intervertebral fusion device - lumbar

    FDA Enforcement
    Class II ·Ongoing·Medicrea International·August 30, 2023

    Balt extrusion SAS

    Importer
    🇫🇷 France·2 Manufacturers

    IMPIX ALIF, REF numbers: a) B15111209, b) B15111212, c) B15111409, d) B15111412; intervertebral fusion device - lumbar

    FDA Enforcement
    Class II ·Ongoing·Medicrea International·August 30, 2023

    IMPIX S, REF numbers: a) B15328071S, b) B15328073S, c) B15328074S, d) B15334072S, e) B15334073S, f) B15334074S; intervertebral fusion device - cervical

    FDA Enforcement
    Class II ·Ongoing·Medicrea International·August 30, 2023

    API NH (REF 10400) API NH is a standardized system for the identification of Neisseria, Haemophilus (and related genera) and Moraxella catharrhalis (Branhamella catarrhalis), which uses miniaturized tests, as well as a specially adapted database. API NH also enables the biotyping of Haemophilus influenza and Haemophilus parainfluenxzae, as well as the detection of a penicllinase.

    FDA Enforcement
    Class II ·Terminated·Biomerieux France Chemin De L'Or·February 5, 2014

    API Listeria (REF 10300) API Listeria is a standardized system for the identification of Listeria which uses miniaturized tests, as well as a database. The ZYM B reagent is including in API Listeria kit and it is used as an additional reagent for revealing the result of DIM miniaturized biochemical test included in the API Listeria strips. ZYM B reagent is added in the DIM test before reading miniaturized biochemical test including in the API Listeria strips.

    FDA Enforcement
    Class II ·Terminated·Biomerieux France Chemin De L'Or·February 5, 2014

    IMPIX DLIF, REF numbers: a) B16123509, b) B16123511, c) B16124009, d) B16124013, e) B16124509, f) B16124511, g) B16124513, h) B16164009, i) B16164013, j) B16165009, k) B16165013; intervertebral fusion device - lumbar

    FDA Enforcement
    Class II ·Ongoing·Medicrea International·August 30, 2023

    Medicrea Pass LP, REF B02217545, Non Sterile, Material: Ti-6Al-4V ELI, VIS PEDICULAIRE POLYAXIALE 7.5MM x 45MM, POLYAXIAL PEDICLE SCREW 7.5MM x 45 MM, POLYAXIAL PEDIKELSCHRAUBE 7.5MM X 45MM, TORNILLO PEDICULAR POLIAXIAL 7.5MM x 45MM VITE POLIASSIALE PEDUNCOLARE 7.5MM x 45MM, PARAFUSO PEDICULAR POLIAXIAL 7.5MM x 45MM, POLYAXIALE PEDICULAIRE SCHROEF 7.5MM x 45MM, POLYAXIALE PEDICULAIRE SCHROEF 7.5MM x 45MM, WIELOOSIOWA SRUBA TRANSPEDIKULARNA 7.5MM x 45MM, (01)03613720177906(10)19A0630(17)290103, RX only

    FDA Enforcement
    Class II ·Terminated·Medicrea International·January 8, 2020