BEUDAMED
    27 results · 35ms · Sources: EU EUDAMED, US FDA

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    VARELISA SM ANTIBODIES

    FDA 510(k)
    FDA Class 2 ·Immunology

    Philips DigitalDiagnost Systems with M Cabinet Model: 712025 Stationary radiographic system, digital-Universal RAD Applications

    FDA Enforcement
    Class II ·Terminated·Philips Healthcare Inc.·September 26, 2012

    TiMESH

    FDA UDI
    pfm medical titanium gmbh·04042301097606·Ti-Mesh 6" X 6" Light 35g/m²

    Keystone Industries

    FDA UDI
    Keystone Industries·H66870003121·D-3 HVE Tips/Wht -KI

    NiTi Archwires

    FDA UDI
    ORTHO TECHNOLOGY, INC.·00190730013675·NiTi RCS Type 5 Upper 020 10 archwires per pack

    TruFlex

    FDA UDI
    ORTHO TECHNOLOGY, INC.·00190730014641·NiTi RCS Upper 020 10 archwires per pack

    TruFlex™

    FDA UDI
    Ortho Organizers, Inc.·00190707125998·TRUFLEX NiTi RCS Upper 020 (10pk)

    OsteoMed

    FDA UDI
    OSTEOMED LLC·00845694026949·PrimaLOK SP 12mm Implant Sizer

    e-vive II NMES System

    FDA UDI
    Motive Health, Inc.·00854691008858·e-vive II NMES System with Post-Op Brace; 2XL/3...

    STEM: MASTERLOC 01.39.207 CEMENTLESS TI COATED LAT STEM SIZE 7

    FDA Adverse Event
    Injury ·MEDACTA INTERNATIONAL SA·Product code LZO·February 22, 2023

    IMMULITE PHENOBARBITAL, MODELS LKPB1, LKPB5

    FDA 510(k)
    FDA Class 2 ·Clinical Toxicology

    ACUCAM CONCEPT IV, MODELS A1222B, A1223B, A1221B, A1121B, A1222C, A10402, A10403, A10401

    FDA 510(k)
    FDA Class 1 ·Dental

    TUFF TT IMPLANT

    FDA Adverse Event
    Injury ·NORIS MEDICAL LTD·Product code DZE·September 25, 2025

    CARPENTIER-EDWARDS PERIMOUNT MAGNA EASE PERICARDIAL BIOPROSTHESIS

    FDA Adverse Event
    Injury ·EDWARDS LIFESCIENCES·Product code DYE·March 12, 2013

    PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP

    FDA Adverse Event
    Malfunction ·MEDTRONIC PUERTO RICO OPERATIONS CO.·Product code OYC·August 11, 2014

    SECURE II MED/SURG BED

    FDA Adverse Event
    Malfunction ·STRYKER MEDICAL·Product code FNL·February 18, 2011

    HUDSON ET TUBE, HVT, 8.0

    FDA Adverse Event
    Injury ·TELEFLEX MEDICAL·Product code BTR·November 19, 2021

    BrightView SPECT gamma camera for Emission Computed Tomography, Philips Medical Systems, Cleveland, OH 44143 BrightView SPECT is a gamma camera designed for single or dual detector nuclear imaging accommodating a broad range of emission computed tomography Emission Computed Tomography (ECT) studies.

    FDA Enforcement
    Class II ·Terminated·Philips Medical Systems (Cleveland) Inc·June 12, 2013

    Smiths Medical, Medfusion¿ Syringe Infusion Pump, Model 4000, Software Version V1.0 & V1.1, Reorder Numbers 4000-0100-50, 4000-0100-95, 4000-0101-50, 4000-0101-51, and 4000-0101-78. Designed for use in care areas for the administration of fluids requiring precisely controlled infusion rates.

    FDA Enforcement
    Class I ·Terminated·Smiths Medical ASD, Inc.·August 8, 2012

    BrightView, Gamma Camera System, Product Code 882480.

    FDA Enforcement
    Class II ·Ongoing·Philips North America·January 17, 2024