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

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    CUT RESISTANT GLOVE LINER

    FDA 510(k)
    FDA Class 1 ·General, Plastic Surgery

    NA

    FDA UDI
    Zimmer, Inc.·00889024156135·

    NA

    FDA UDI
    Zimmer, Inc.·00889024156142·

    OSOM INFLUENZA A&B TEST , MODEL PN190

    FDA 510(k)
    FDA Class 2 ·Microbiology

    SILMAX PECTORAL IMPLANT

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

    CS300

    FDA Adverse Event
    Malfunction ·DATASCOPE CORP·Product code DSP·May 9, 2014

    ATLAS II HF CRT-D

    FDA Adverse Event
    Malfunction ·ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION·Product code NIK·January 8, 2013

    CAPSUREFIX NOVUS

    FDA Adverse Event
    Death ·MEDTRONIC PUERTO RICO, INC.·Product code DTB·November 18, 2010

    IPC® HANDPIECE - XPS® STRAIGHTSHOT® M4

    FDA Adverse Event
    Injury ·MEDTRONIC XOMED INC.·Product code ERL·February 13, 2017

    UniCel DxI 600 Access Immunoassay Analyzer, Part Number A30260

    FDA Enforcement
    Class II ·Ongoing·Beckman Coulter, Inc.·August 13, 2025

    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