BEUDAMED
    22 results · 24ms · Sources: EU EUDAMED, US FDA

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    RIWO SYSTEM TRAYS

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

    Zirlux

    FDA UDI
    HENRY SCHEIN, INC.·00304040056103·Zirlux Multi Anterior A1,98.5X14

    Cosmolock

    FDA UDI
    Kalitec Direct LLC·B07310K0123000·Recovery Tube, MIS

    neoWave LS

    FDA UDI
    XENIX MEDICAL LLC·00818345024045·Paddle Shaver, 9mm

    InTess Lumbar Cage

    FDA UDI
    Kalitec Direct LLC·B07312K0103090·Shaver, Closed, 9mm

    Navagio

    FDA UDI
    Kalitec Direct LLC·B07330K0132090·Trial, TLIF, 27L OB CRV 7Deg, 9mm

    LUTE VLC; CORE VLC

    FDA 510(k)
    FDA Class 2 ·Dental

    SONOPET MODEL UST-2001 ULTRASONIC SURGICAL ASPIRATOR

    FDA 510(k)
    FDA Unclassified ·Unknown

    INSET

    FDA Adverse Event
    Malfunction ·UNOMEDICAL DEVICES S.A. DE C.V.·Product code FPA·November 5, 2025

    INSET

    FDA Adverse Event
    Malfunction ·UNOMEDICAL A/S·Product code FPA·October 10, 2025

    BD PHASEAL OPTIMA INJECTOR (N35-O)

    FDA Adverse Event
    Malfunction ·BECTON DICKINSON, S.A.·Product code ONB·July 9, 2021

    7MM TI CURVED RADIAL STEM 42MM-STERILE

    FDA Adverse Event
    Injury ·SYNTHES MONUMENT·Product code KWI·April 12, 2017

    HIRES 90K IMPLANT

    FDA Adverse Event
    Injury ·ADVANCED BIONICS LLC·Product code MCM·March 12, 2013

    B/F GLENOID STRAIGHT SPOKE REAMER ASSEMBLY

    FDA Adverse Event
    Malfunction ·ZIMMER, INC.·Product code HTO·February 1, 2011

    PRESERVATION UNI FEM CEM SZ2

    FDA Adverse Event
    Injury ·DEPUY-CORK, A DIV OF DEPUY ORTHOPAEDICS·Product code NJL·February 11, 2008

    7MM TI CURVED RADIAL STEM 42MM-STERILE

    FDA Adverse Event
    Malfunction ·SYNTHES MONUMENT·Product code KWI·February 4, 2015

    7MM TI CURVED RADIAL STEM 42MM-STERILE

    FDA Adverse Event
    Malfunction ·SYNTHES MONUMENT·Product code KWI·February 4, 2015

    Pilonplate with Angular Stability, with the below descriptions and corresponding article numbers. 1. Anterolateral Tibia Plate; Article Numbers: 21311-11, 21311-15, 21311-7, 21312-11, 21312-15, 21312-7. 2. Pilon Plate 4mm; Article Numbers: 21094-10, 21094-4, 21094-6, 21094-8. 3. Pilon Plate, Small; Article Numbers: 21093-4, 21093-6.

    FDA Enforcement
    Class II ·Ongoing·I.T.S. GmbH·April 1, 2026

    Stryker MA204 Bed Model (FL25E) Beds are intended for medical purposes in both general patient care as well as critical care environments. Each uses built-in electric motors and controls which can be operated by the patient, or caregiver, to adjust the height and/or surface contour of the bed.The devices listed above also include movable and latchable side rails which can be lowered or raised to help prevent patient fall and subsequent injury. The Beds include an optional Scale (Models: FL20E, FL25E, FL28C, FL28EX) as well as an optional Bed Exit (1 Zone) or Chaperone

    FDA Enforcement
    Class II ·Terminated·Stryker Medical Division of Stryker Corporation·July 4, 2012

    BioButton REF BIOST06040 with Software version 3.0.20 The BioButton System is a remote monitoring wearable device intended for continuous collection of physiological data in home and healthcare settings while the patient is at rest.

    FDA Enforcement
    Class II ·Ongoing·Biointellisense Inc.·August 21, 2024