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

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    TMS FULL ADVANTAGE FULL FACE MASK, MODELS TMS-2820, TMS-2830, TMS-2840

    FDA 510(k)
    FDA Class 2 ·Anesthesiology

    SARSTEDT NEEDLE PROTECTOR

    FDA 510(k)
    FDA Class 2 ·General Hospital

    MODIFICATION TO: STACKABLE CAGE SYSTEM

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    POLYFLUX 17L

    FDA Adverse Event
    Malfunction ·BAXTER HEALTHCARE - HECHINGEN BADEN DIALYZER·Product code KDI·January 14, 2020

    ENDOTAK RELIANCE

    FDA Adverse Event
    Malfunction ·CPI - DEL CARIBE·Product code NVY·April 9, 2013

    9800

    FDA Adverse Event
    Malfunction ·GE OEC MEDICAL SYSTEMS (SLC)·Product code JAA·March 28, 2011

    CONTAK RENEWAL 3 RF

    FDA Adverse Event
    Malfunction ·CARDIAC PACEMAKERS, INC·Product code NIK·May 8, 2008

    Daig Livewire Steerable, Product Number 401904; REPROCESSED ELECTROPHYSIOLOGY CATHETER

    FDA Enforcement
    Class II ·Ongoing·Stryker Sustainability Solutions·May 20, 2026

    Thoratec HeartMate 3, LVAS Implant Kit, REF:106524INT, Sterile EO, RxOnly

    FDA Enforcement
    Class I ·Ongoing·Thoratec Corp.·May 8, 2024

    Thoratec HeartMate 3, LVAS Implant Kit, REF:106524US, Sterile EO, RxOnly

    FDA Enforcement
    Class I ·Ongoing·Thoratec Corp.·May 8, 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