BEUDAMED
    14 results · 24ms · Sources: EU EUDAMED, US FDA

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    DELICOT

    FDA 510(k)
    FDA Class 2 ·Neurology

    SureCore Automatic Disposable Biopsy Needle

    FDA UDI
    Canyon Medical Inc.·06954414659016·Automatic Disposable Biopsy Needle

    Z Liquid HT C2-C 100ml

    FDA UDI
    ARGEN CORPORATION, THE·D818121822·Dental porcelain/ceramic restoration kit

    NA

    FDA UDI
    Smith & Nephew, Inc.·03596010064820·4.0MM PARTIALLY THREADED ...

    EXIN

    FDA UDI
    FOREMOUNT ENTERPRISE CO., LTD.·04719871893425·Standard cushion mask without valve #2

    NON-STERILE POWDER-FREE BLUE NITRILE EXAMINATION GLOVES TESTED FOR USE WITH CHEMOTHERAPY DRUGS

    FDA 510(k)
    FDA Class 1 ·General Hospital

    R120 MODULAR TOTAL HIP SYSTEM

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    UNKNOWN DEPUY PINNACLE METAL LINER

    FDA Adverse Event
    Injury ·DEPUY INTL., LTD. ¿ REG. # 8010379·Product code KWA·May 21, 2013

    840 VENTILATOR

    FDA Adverse Event
    Injury ·COVIDIEN·Product code CBK·September 26, 2014

    ACCESS 2 IMMUNOASSAY SYSTEM

    FDA Adverse Event
    Malfunction ·BECKMAN COULTER, INC.·Product code CGN·May 20, 2011

    BEACON TIP TORCON NB ADVANTAGE ANGIOGRAPHIC CATHETER

    FDA Adverse Event
    Injury ·COOK INC·Product code DQO·November 26, 2025

    Stago IVD, Liquid Anti-Xa, NDC 3607450003116. The STA - Liquid Anti-Xa kits are intended for use with STA-R, STA Compact and STA Satellite Analyzers for the quantitative determination of the plasma levels of unfractionated (UFH) and low molecular weight (LMWH) heparins by measuring their anti-Xa activity on antithrombin in a competitive assay using a synthetic chromogenic substrate.

    FDA Enforcement
    Class III ·Terminated·Diagnostica Stago, Inc.·September 24, 2014

    Microtek Medical, Inc. ORS Fluid Warming and Slush Drapes, Model #'s ORS-100, ORS-110, ORS-130, ORS-300, ORS-301, ORS-320, ORS-321, ORS-325, ORS-330, ORS-331 and ORS-2200. The ORS Fluid Warming and Slush Drapes are individually wrapped and placed in poly-Tyvek pouches with a label insert, then packaged as 24 per case in a labeled corrugated shipper box. Intended for use during various surgeries where warm irrigation, slush and/or cold solution are required.

    FDA Enforcement
    Class II ·Terminated·Ecolab Inc·September 30, 2015

    Exactech Equinoxe CAGE GLENOID,POSTERIOR AUGMENT, CEMENTED, Left, Mates with: a) 38, 41, 44, 47 head, Small, Item Number 314-13-22, b) 41, 44, 47, 50, head, Medium, Item Number 314-13-23, c) 44, 47, 50, 53 head, Large, Item Number 314-13-24, d) 44, 47, 50, 53 head, Extra Large, Item Number 314-13-25; Shoulder Arthroplasty

    FDA Enforcement
    Class II ·Ongoing·Exactech, Inc.·April 10, 2024