BEUDAMED
    9 results · 19ms · Sources: EU EUDAMED, US FDA

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    AIRCRAFT MEDICAL OXYGEN GENERATION SYSTEM (AMOGS)

    FDA 510(k)
    FDA Class 2 ·Anesthesiology

    STRIPMAX 1210 URINE CHEMISTRY ANALYZER, URIMATE REAGENT STRIP FOR URINALYSIS

    FDA 510(k)
    FDA Class 1 ·Clinical Chemistry

    DJ ORTHOPEDICS FEMORAL ANCHOR

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    11MM/130 DEG TI CANN TROCH FIXATION NAIL 380MM/LEFT-STER

    FDA Adverse Event
    Malfunction ·SYNTHES MONUMENT·Product code HSB·April 29, 2013

    DEXTRUS 4136

    FDA Adverse Event
    Malfunction ·BIOTRONIK SE & CO. KG·Product code NVZ·April 29, 2011

    GEM

    FDA Adverse Event
    Malfunction ·MEDTRONIC, INC. CARDIAC RHYTHM DISEASE MANAGEMENT·Product code LWS·July 17, 2008

    BARD Dynamic Deca Steerable, Product Number 201101; REPROCESSED ELECTROPHYSIOLOGY CATHETER

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

    On-Board Imager - Exact Arm Elbow Motor Shaft (kVD, kVS, and MV) with ''Type 01" elbow motors. Product Usage: The On-Board Imager device is an x-ray device used for evaluation of correct patient position in relation to isocenter and verification of treatment fields in relation to anatomical and fiducial landmarks.

    FDA Enforcement
    Class II ·Terminated·Varian Medical Systems, Inc.·April 30, 2014

    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