BEUDAMED
    22 results · 32ms · Sources: EU EUDAMED, US FDA

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    BD PEN NEEDLE

    FDA 510(k)
    FDA Class 2 ·General Hospital

    BD INSULIN PEN NEEDLE

    FDA Adverse Event
    Injury ·BECTON DICKINSON AND CO.·Product code FMI·November 9, 2015

    LOCATOR R-Tx

    FDA UDI
    Zest Anchors, LLC·00840481124693·LOCATOR R-Tx Attachment System for CSR-DAT-N In...

    Humeris Shoulder

    FDA UDI
    FX SOLUTIONS·03701037307267·ASYMETRIC GLENOID K-WIRE GUIDE SIZE XS/S +5mm

    Integrity-SI Fusion System

    FDA UDI
    Lincotek Medical LLC·B57112521110105·10 x 105 mm Anodized SI Implant Fully Threaded

    NA

    FDA UDI
    STRYKER CORPORATION·04546540076519·2.2mm Lindemann Drill Bit

    POWDER-FREE, NATURAL COLOR, LATEX EXAMINATION GLOVE MODEL: MEPF1

    FDA 510(k)
    FDA Class 1 ·General Hospital

    SYNCRO - BLUE TUBE, THE MAGNETICALLY GUIDED ENTERAL FEEDING TUBE- 8FR TUBE

    FDA 510(k)
    FDA Class 2 ·Gastroenterology, Urology

    OPTILENE MESH 10 X 15 CM

    FDA Adverse Event
    Malfunction ·B. BRAUN SURGICAL SA·Product code FTL·April 17, 2015

    PRECISION

    FDA Adverse Event
    Injury ·BOSTON SCIENTIFIC NEUROMODULATION·Product code LGW·February 19, 2020

    LAG/COM SCREW KIT 110/105

    FDA Adverse Event
    Injury ·SMITH & NEPHEW, INC.·Product code JDS·March 29, 2019

    LAG/COM SCREW KIT 110/105

    FDA Adverse Event
    Injury ·SMITH & NEPHEW, INC.·Product code JDS·February 27, 2022

    MECHANICAL (MANUAL) WHEELCHAIR

    FDA Adverse Event
    DANYANG MAXTHAI MEDICAL EQUIPMENT·Product code IOR·May 13, 2013

    RESTORE

    FDA Adverse Event
    Injury ·MEDTRONIC PUERTO RICO OPERATIONS CO.·Product code LGW·September 23, 2014

    COULTER® LYSE S III DIFF LYTIC REAGENT

    FDA Adverse Event
    Malfunction ·BECKMAN COULTER, INC.·Product code GGK·June 1, 2011

    Baxter Interlink System Minivolume Extension Set, product code 1C8483; 18'', 1.3 mL Vol., with 0.22 Micron Downstream Filter, 2 injection sites and a male Luer Lock adapter; Baxter Healthcare Corporation, Deerfield, IL 60015 U.S.A.

    FDA Recall
    Terminated ·Baxter Healthcare Corp. Rt.·Product code FPA·July 6, 2005

    EG-3630U Ultrasound Video Gastroscope EG-3830UT Ultrasound Video Gastroscope EG-3870UTK Ultrasound Video Gastroscope FG-36UX Ultrasound Fiber Gastroscope Used to provide optical and sonographic visualization of and therapeutic access to the Upper Gastrointestinal Tract.

    FDA Enforcement
    Class II ·Terminated·Pentax Medical Company·July 30, 2014

    Spectral CT 7500, Software Version 5.0.0.X. Computed Tomography X-Ray System.

    FDA Enforcement
    Class II ·Ongoing·Philips North America Llc·January 24, 2024

    Spectral CT. Computed tomography X-ray system.

    FDA Enforcement
    Class II ·Ongoing·Philips North America Llc·July 2, 2025

    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