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

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    ESA LEADCARE II LEAD CONTROL

    FDA 510(k)
    FDA Class 1 ·Clinical Toxicology

    HOLOGIC QDR X-RAY BONE DENSITOMETER, MODELS 1000, 2000, 4500, DELPHI, DISCOVERY

    FDA 510(k)
    FDA Class 2 ·Radiology

    WIRECLIP TORQUER

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    EQUINOXE PRIMARY SHOULDER COMPONENTS

    FDA Adverse Event
    Injury ·EXACTECH, INC.·Product code KWT·March 24, 2026

    12/14 ARTICUL 40MM M SPEC+12

    FDA Adverse Event
    Injury ·DEPUY INTERNATIONAL LTD. 8010379·Product code JDI·April 17, 2013

    HOMECHOICE AUTOMATED PD SET WITH CASSETTE

    FDA Adverse Event
    Injury ·BAXTER HEALTHCARE - MOUNTAIN HOME·Product code FKX·April 19, 2011

    JOSTENT GRAFTMASTER

    FDA Adverse Event
    Injury ·ABBOTT VASCULAR-CARDIAC THERAPIES·Product code MAF·June 19, 2008

    BD Connecta Stopcock Without Extension Tube Catalog No. 394602 (OUS)

    FDA Enforcement
    Class II ·Ongoing·Becton Dickinson & Company·July 27, 2022

    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

    CADD¿- Solis Ambulatory Infusion Pump, Model 2111 & 2112, Version 1.0, Version 2.0 and Version 3.0 & Model 2120, Version 1.0. Provide measured drug therapy to patients in hospital or outpatient settings.

    FDA Enforcement
    Class II ·Terminated·Smiths Medical ASD, Inc.·June 24, 2015

    TRULIANT Knee System including TRULIANT Tibial Inserts, also labeled as the following: a. TRULIANT CR Tibial Inserts; b. TRULIANT CR Slope + Tibial Inserts; c. TRULIANT CR Slope ++ Tibial Inserts; d. TRULIANT CRC Tibial Inserts; e. TRULIANT PS Tibial Inserts; f. TRULIANT PSC Tibial Inserts. NOTE: Information reflects Exactech recall expansion initiated on 02/07/2022.

    FDA Enforcement
    Class II ·Ongoing·Exactech, Inc.·October 13, 2021