BEUDAMED
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    OPTICAL COHERENCE TOMOGRAPHY 3D OCT-2000

    FDA 510(k)
    FDA Class 2 ·Ophthalmic

    MODIFICATION TO N PROTEIN STANDARD SL

    FDA 510(k)
    FDA Class 2 ·Clinical Chemistry

    M2424A SONOS 5500/4500 DIAGNOSTIC ULTRASOUND SYSTEM, VERSION B.2. 21330A TRANSDUCER

    FDA 510(k)
    FDA Class 2 ·Radiology

    BDRV CANN SCW SS P/T DIA4.5X60MM

    FDA Adverse Event
    Injury ·BIOMET SPAIN, S.L.·Product code HRS·January 26, 2017

    BDRV CANN SCW SS P/T DIA4.5X52MM

    FDA Adverse Event
    Injury ·BIOMET SPAIN, S.L.·Product code HRS·January 26, 2017

    SOL-MILLENNIUM

    FDA Adverse Event
    Malfunction ·SOL-MILLENNIUM MEDICAL INC·Product code FMF·May 16, 2025

    ACCU-CHEK ® MULTICLIX

    FDA Adverse Event
    Malfunction ·ROCHE DIAGNOSTICS·Product code FMK·May 3, 2013

    WALLFLEX? BILIARY

    FDA Adverse Event
    Malfunction ·BOSTON SCIENTIFIC - GALWAY·Product code FGE·September 16, 2014

    9900

    FDA Adverse Event
    Malfunction ·GE OEC MEDICAL SYSTEMS (SLC)·Product code JAA·May 2, 2011

    BIOMET StageOne Hip Cement Spacer Mold with Insert, 64 MM, Silicone, Sterile, Item 431185.

    FDA Enforcement
    Class II ·Terminated·Biomet, Inc.·April 15, 2020

    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