BEUDAMED
    11 results · 19ms · Sources: EU EUDAMED, US FDA

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    LED TURBO-PEN

    FDA 510(k)
    FDA Class 2 ·Dental

    BREAST IMMOBILIZATION DEVICE MR-BY 160

    FDA 510(k)
    FDA Class 2 ·Radiology

    RANDOX PHENOBARBITAL

    FDA 510(k)
    FDA Class 2 ·Clinical Toxicology

    ONETOUCHPING GLUCOSEMGMTSYSTEM

    FDA Adverse Event
    Malfunction ·ANIMAS CORPORATION·Product code LZG·April 8, 2013

    ALLOCLASSIC SL STEM 01 12/14

    FDA Adverse Event
    Injury ·ZIMMER GMBH·Product code LZO·March 25, 2011

    LARGE NEEDLE DRIVER INSTRUMENT

    FDA Adverse Event
    Malfunction ·INTUITIVE SURGICAL, INC.·Product code GCJ·May 9, 2008

    Smith & Nephew ACUFEX Rap-Pac ACL Accessory Kit, Sterile Catalog Number: 014725

    FDA Recall
    Terminated ·Smith & Nephew, Inc.·Product code HRX·November 8, 2002

    Medfusion Syringe Pump, Model 4000. The Model 4000 pump is a small, lightweight and portable syringe infusion pump. The pump offers a variety of delivery modes programmable to meet specific patient care needs.

    FDA Enforcement
    Class I ·Terminated·Smiths Medical ASD Inc.·December 18, 2019

    Thoratec HeartMate 3, LVAS Implant Kit, REF:106524INT, Sterile EO, RxOnly

    FDA Enforcement
    Class I ·Ongoing·Thoratec Corp.·May 8, 2024

    Thoratec HeartMate 3, LVAS Implant Kit, REF:106524US, Sterile EO, RxOnly

    FDA Enforcement
    Class I ·Ongoing·Thoratec Corp.·May 8, 2024

    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