BEUDAMED
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    REPROCESSED ELECTROPHYSIOLOGY CATHETER

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    MEDISYSTEMS LUER ACCESS INJECTION SITE

    FDA 510(k)
    FDA Class 2 ·General Hospital

    STAPLETAC2 BONE ANCHOR SYSTEM

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    VIBRANT SOUNDBRIDGE

    FDA Adverse Event
    Injury ·VIBRANT MED-EL HEARING TECHNOLOGY GMBH·Product code MPV·March 28, 2013

    AED PRO

    FDA Adverse Event
    Malfunction ·ZOLL MEDICAL CORPORATION·Product code MKJ·March 21, 2011

    DIMENSION CLINICAL CHEMISTRY SYSTEM

    FDA Adverse Event
    Malfunction ·SIEMENS HEALTHCARE DIAGNOSTICS, INC.·Product code MMI·April 15, 2008

    AIMING ARM/ RADIOLUCENT

    FDA Adverse Event
    Malfunction ·SYNTHES GMBH·Product code JDS·September 9, 2024

    Stryker Locking Screw, Fully Threaded T2 Tibia ¿5x35 mm Catalog Number: 18965035S - Product Usage: Stryker implants are single use devices intended for the temporary fixation, correction or stabilization of bones.

    FDA Enforcement
    Class II ·Terminated·Stryker GmbH·June 24, 2020

    Aurora 4 Series, Aurora 7 lighthead; Models: AUA7 (including TV models). The Aurora Series is intended to illuminate the surgical field and ensure visibility of the surgical site.

    FDA Enforcement
    Class II ·Ongoing·DKK Dai-Ichi Shomei Co., Ltd.·August 21, 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