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

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    ACCOLADE II LASER

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

    BARD ALL-SILICONE 3-WAY FOLEY CATHETER; BARD LUBRI-SIL 3-WAY FOLEY CATHETER; BARD LUBRI-SIL I.C. 3-WAY FOLEY CATHETER

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

    MICROMEDICS FIBRIJET AEROSOL APPLICATOR

    FDA 510(k)
    FDA Class 2 ·General Hospital

    VITEK 2 AST-P606 ANTIMICBROBIAL SUSCEPTIBILITY TEST KIT

    FDA Adverse Event
    Malfunction ·BIOMÉRIEUX, INC.·Product code LON·February 23, 2015

    ACCESS® 2 IMMUNOASSAY SYSTEM

    FDA Adverse Event
    Injury ·BECKMAN COULTER·Product code MMI·April 23, 2013

    ADVANTA BED

    FDA Adverse Event
    Malfunction ·HILL-ROM, INC.·Product code FNL·March 31, 2011

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    FDA Adverse Event
    Injury ·MEDTRONIC PUERTO RICO, INC.·Product code DTB·July 10, 2008

    PERCLOSE PROGLIDE 6F SUTURE MEDIATED CLOSURE (SMC) SYSTEM

    FDA Adverse Event
    Injury ·AV-TEMECULA-CT·Product code MGB·November 10, 2017

    Equinoxe Reverse Shoulder Compression Screw/Locking Cap Kit 4.5 x 18 mm.

    FDA Enforcement
    Class II ·Terminated·Exactech, Inc.·October 7, 2020

    LOCATOR Implant Attachment System. The LOCATOR Implant Attachment System is a universal hinge, resilient attachment for endosseous implants. The LOCATOR Implant Attachment System is designed for use with overdentures or partial dentures, retained in whole or in part, by endosseous implants in the mandible or maxilla. FDA 510(k): K994257, K072878

    FDA Recall
    Terminated ·Zest Anchors LLC·Product code DZE·January 16, 2014

    LOCATOR¿ Implant Attachment System. The LOCATOR¿ Implant Attachment System is a universal hinge, resilient attachment for endosseous implants. The LOCATOR¿ Implant Attachment System is designed for use with overdentures or partial dentures, retained in whole or in part, by endosseous implants in the mandible or maxilla. FDA 510(k): K994257, K072878

    FDA Enforcement
    Class II ·Terminated·Zest Anchors LLC·February 12, 2014

    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