BEUDAMED
    16 results · 22ms · Sources: EU EUDAMED, US FDA

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    Disposable Procedural Ear-loop Face Mask

    FDA 510(k)
    FDA Class 2 ·General, Plastic Surgery

    LUPINE

    FDA UDI
    Medos International Sàrl·10886705001545·LUPINE Spiral Fluted Drill Bit Reusable Instrument

    PMT® Halo Systems

    FDA UDI
    PMT CORPORATION·00650551110675·HALO, 1203-5 VEST PED1, ACRYLIC LINER, 1211-1 X...

    KINCISE™ System Acetabular Cup Extraction Polymer Head 42mm

    FDA UDI
    Spierings Orthopaedics B.V.·08720254007120·

    ATRICURE CRYO MODULE

    FDA 510(k)
    FDA Class 2 ·General, Plastic Surgery

    PROBEAT-CR

    FDA 510(k)
    FDA Class 2 ·Radiology

    NARROW STANDARD LARGE HEXED DRIVER, 24MM

    FDA Adverse Event
    Malfunction ·BIOMET 3I·Product code NDP·January 2, 2020

    TUBE, GASTROINTESTINAL (AND ACCESS)

    FDA Adverse Event
    Injury ·C. R. BARD INC. (BASD)·Product code KNT·October 24, 2008

    SETROX S 53

    FDA Adverse Event
    Malfunction ·BIOTRONIK SE & CO. KG·Product code NVN·October 29, 2014

    ENDOTAK RELIANCE

    FDA Adverse Event
    Injury ·CPI - DEL CARIBE·Product code NVY·July 8, 2013

    LUPINE SPIRAL FLUTED DRILL BIT

    FDA Adverse Event
    Malfunction ·DEPUY MITEK LLC US·Product code HTW·February 16, 2018

    smiths medical Pneupac paraPAC plus 300 ventilator kit without PEEP and CPAP, REF P300NUS

    FDA Enforcement
    Class I ·Ongoing·Smiths Medical ASD Inc.·March 27, 2024

    paraPAC 300 ventilator kit without internal PEEP and CPAP, Item Number P300N

    FDA Enforcement
    Class I ·Ongoing·Smiths Medical ASD Inc.·October 2, 2024

    Model Number L211 PROPONENT DR SL MRI Pacemaker

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

    Allura system; System Code Description (Model Numbers): Allura Xper FD10 (722003, 722010, 722026), Allura Xper FD10 OR Table (722022, 722033), 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);

    FDA Enforcement
    Class II ·Ongoing·PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.·June 3, 2026

    PROPONENT DR Pacemaker, SL (Model Number L201), (VDD) SL (Model Number L209), SL MRI (Model Number L211), EL (Model Number L221), and EL MRI (Model Number L231).

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