BEUDAMED
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    VERIFY SIRIUS BIOLOGICAL INDICATOR CHALLENGE PACK

    FDA 510(k)
    FDA Class 2 ·General Hospital

    Cook

    FDA UDI
    COOK INCORPORATED·00827002145719·Fascial TFE Dilator

    INTRAORAL MANDIBULAR DISTRACTION SYSTEM

    FDA 510(k)
    FDA Class 2 ·Dental

    WHITESIDE BIOMECHANICS LOW PROFILE STAINLESS STEEL CABLE SYSTEM, MODEL BIO-1-1014

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    1020279-2013-00225

    FDA Adverse Event
    Injury ·SMITH & NEPHEW, INC.·Product code JWH·April 23, 2013

    INTERSTIM II

    FDA Adverse Event
    Injury ·MDT PUERTO RICO OPERATIONS CO., JUNCOS·Product code EZW·April 27, 2011

    TENDRIL SDX

    FDA Adverse Event
    Injury ·ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION·Product code DTB·July 11, 2008

    NSK

    FDA Adverse Event
    Injury ·NAKANISHI INC.·Product code DZI·October 6, 2020

    NSK

    FDA Adverse Event
    Injury ·NAKANISHI INC.·Product code DZI·July 15, 2025

    ROD, FIXATION, INTRAMEDULLARY

    FDA Adverse Event
    Injury ·SYNTHES (USA)·Product code HSB·January 22, 2017

    NSK

    FDA Adverse Event
    Malfunction ·NAKANISHI INC.·Product code ELC·September 9, 2016

    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