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

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    Sterile Syringe for Single Use (with Needle), Sterile Hypodermic Needle for Single Use

    FDA 510(k)
    FDA Class 2 ·General Hospital

    MICROFIX QUICKANCHOR ETHIBOND

    FDA UDI
    DEPUY MITEK, LLC·10886705002467·MICROFIX QUICKANCHOR Plus (4/0 Suture) Poly (L-...

    Paxeon BiPolar Head

    FDA UDI
    PAXEON RECONSTRUCTION LLC·08177570201976·Bipolar Head Size 28/57

    BiPolar Head

    FDA UDI
    SIGNATURE ORTHOPAEDICS PTY LTD·09348215053055·

    Signature BiPolar Head

    FDA UDI
    SIGNATURE ORTHOPAEDICS PTY LTD·09348215004101·

    OrthoMedFlex

    FDA UDI
    ORTHOMEDFLEX LLC·M7161112128570·Bipolar Head size 57

    NON-STERILE POWDER FREE PURPLE LATEX EXAMINATION GLOVE WITH BLUEBERRY SCENTED AND PROTEIN CONTENT CLAIM (50 MICROGRAMS O

    FDA 510(k)
    FDA Class 1 ·General Hospital

    INTERFACE BONE VOID FILLER

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    TENDRIL STS

    FDA Adverse Event
    Malfunction ·ST. JUDE MEDICAL, INC. CRMD·Product code DTB·January 13, 2014

    TOTALCARE

    FDA Adverse Event
    Malfunction ·HILL-ROM INC.·Product code FNL·July 12, 2011

    XMAX MOTOR

    FDA Adverse Event
    Malfunction ·DEPUY SYNTHES POWER TOOLS·Product code ERL·July 9, 2013

    AC Power Cords, 110V Manufactured by Electri-Cord Manufacturing Company in Westfield, PA. Power Cord #4102204 used with Tricell 60601 Model 212857, First Step Select Model 215200 , and Plexipulse Model 205835.

    FDA Recall
    Terminated ·KCI USA, Inc.·Product code IOQ·November 4, 2009

    Marathon Flow Directed Micro Catheter, UltraFlow HPC Flow Directed Micro Catheter Marathon Flow: The device is intended to access periphera and neurovasculature for the controlled selective infusion of physician-specified therapeutics agents such as embolization materials and of diagnostic materials such as contrast media. UltraFlow HPC Flow: The device is intended for the controlled selective infusion of physician-specified pharmacologic agents or contrast media into the distal vasculature of the peripheral and neuroanatomy. It is not intended for use in the coronary vasculature. Catalog No. 105-5055V02 105-5055V02 105-5055V05 105-5065V02 105-5065V05 105-5066V02 105-5066V05

    FDA Enforcement
    Class I ·Terminated·Micro Therapeutics Inc, Dba Ev3 Neurovascular·November 16, 2016

    Model Number L111, ESSENTIO DR SL MRI Pacemaker

    FDA Enforcement
    Class I ·Ongoing·Boston Scientific Corporation·October 22, 2025

    Allura system; System Code Description (Model Numbers): Allura Xper FD10C (722001), Allura Xper FD10F (722002), Allura Xper FD10 (722003, 722010, 722026), Allura Xper FD10/10 (722005, 722011, 722027), Allura Xper FD20 (722006, 722012, 722028), Allura Xper FD20 Biplane (722008, 722013), Allura Xper FD20 OR Table (722015, 722023, 722035), Allura Xper FD20 Biplane OR Table (722025), Allura Xper FD20/10 (722029), Allura Xper FD20/15 (722058), Allura Xper FD20/15 OR Table (722059), Allura Xper FD20/20 (722038), Allura Xper FD20/20 OR Table (722039), Cardio Vascular-Allura (722400);

    FDA Enforcement
    Class II ·Ongoing·PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.·May 27, 2026

    DRX Revolution Mobile X-Ray System

    FDA Enforcement
    Class II ·Ongoing·Carestream Health, Inc.·December 13, 2023