BEUDAMED
    13 results · 21ms · Sources: EU EUDAMED, US FDA

    Get notified when this changes

    We'll email you when new records match this search — new devices, new clearances, certificate changes, or withdrawals.
    Filters Regulation: Us FDA ×

    Basic Synguard Nitrile Exam Gloves, Powder Free, Blue Colored, Non-Sterile

    FDA 510(k)
    FDA Class 1 ·General Hospital

    OsteoMed

    FDA UDI
    OSTEOMED LLC·00845694036702·FPS 8mm Cannulated Metatarsal Reamer

    BLACKHAWK Cervical Spacer System

    FDA UDI
    Choice Spine, LP·00840996164689·BLACKHAWK,STERILE,CONVEX,14X12X8

    DEROYAL POLY-REINFORCED SURGICAL GOWNS (STERILE, NON-STERILE)

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

    CR 12-X DIGITIZER

    FDA 510(k)
    FDA Class 2 ·Radiology

    BD MICROLANCE¿ NEEDLE

    FDA Adverse Event
    Malfunction ·BECTON DICKINSON, S.A.·Product code FMI·November 9, 2018

    PSX INTERBODY SYSTEM

    FDA Adverse Event
    Injury ·ALPHATEC SPINE, INC.·Product code MAX·April 29, 2025

    FLO-GARD 6201 VOLUMETRIC INFUSION PUMP

    FDA Adverse Event
    Malfunction ·BAXTER HEALTHCARE (SG)·Product code FRN·November 17, 2008

    HYDRO THERMABLATOR (HTA) ENDOMETRIAL ABLATION SYSTEM

    FDA Adverse Event
    Malfunction ·BOSTON SCIENTIFIC - MARLBOROUGH·Product code MNB·September 1, 2011

    API REAGENT - ZYM B TEST KIT

    FDA Adverse Event
    Injury ·BIOMERIEUX SA·Product code JTO·July 15, 2013

    BD MICROLANCE HYPODERMIC NEEDLE 30G X 0.5" YELLOW ¿

    FDA Adverse Event
    Malfunction ·BECTON DICKINSON, S.A.·Product code FMI·October 23, 2017

    TX1 Tissue Removal System. TX1 Procedure Pack P/N 554-1003-001 (outer box), TX1 MicroTip P/N 554-1002-001 (inner tray). For use with the TX System Console as an ultrasonic surgical aspirator of soft tissue.

    FDA Enforcement
    Class II ·Terminated·Tenex Health Inc·May 14, 2014

    Revogene, Catalog no. 610210. IVD test instrument

    FDA Enforcement
    Class II ·Ongoing·Meridian Bioscience Inc·August 3, 2022