BEUDAMED
    12 results · 20ms · Sources: EU EUDAMED, US FDA

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    CD HORIZON SPINAL SYSTEM

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    CD HORIZON® SPINAL SYSTEM

    FDA Adverse Event
    Malfunction ·WARSAW ORTHOPEDICS·Product code KWP·November 25, 2024

    CHARNLEY INIT INCIS RETR

    FDA Adverse Event
    Malfunction ·DEPUY RAYNHAM·Product code LXH·October 18, 2012

    TRANSCURE, MODEL 2910

    FDA 510(k)
    FDA Class 2 ·Dental

    NEUROVISION SE (NERVEANA)

    FDA 510(k)
    FDA Class 2 ·Ear, Nose, Throat

    ANIMAS INSULIN INFUSION PUMP

    FDA Adverse Event
    Malfunction ·ANIMAS CORPORATION·Product code LZG·May 21, 2013

    COLLEAGUE PRE P1.7

    FDA Adverse Event
    Malfunction ·BAXTER HEALTHCARE - SINGAPORE·Product code FRN·June 14, 2011

    ACCU-CHEK COMFORT CURVE TEST STRIPS

    FDA Adverse Event
    Malfunction ·ROCHE DIAGNOSTICS·Product code LFR·August 14, 2008

    SINGLE USE COMBINATION CLEANING BRUSH

    FDA Adverse Event
    Malfunction ·AOMORI OLYMPUS CO., LTD.·Product code MNL·August 27, 2025

    PUMP MMT-1884L MM780G BLE 3.0 MG/ML

    FDA Adverse Event
    Malfunction ·MEDTRONIC PUERTO RICO OPERATIONS CO.·Product code OZP·February 9, 2026

    Microtek Medical, Inc. ORS Fluid Warming and Slush Drapes, Model #'s ORS-100, ORS-110, ORS-130, ORS-300, ORS-301, ORS-320, ORS-321, ORS-325, ORS-330, ORS-331 and ORS-2200. The ORS Fluid Warming and Slush Drapes are individually wrapped and placed in poly-Tyvek pouches with a label insert, then packaged as 24 per case in a labeled corrugated shipper box. Intended for use during various surgeries where warm irrigation, slush and/or cold solution are required.

    FDA Enforcement
    Class II ·Terminated·Ecolab Inc·September 30, 2015

    Exactech Equinoxe REVERSE SHOULDER,42mm Constrained Humeral Liner, a) +0mm, Item number 320-42-10, b) +2.5mm, Item Number 320-42-13; Shoulder Arthroplasty

    FDA Enforcement
    Class II ·Ongoing·Exactech, Inc.·April 10, 2024