BEUDAMED
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    SPECT.E.N.S. REPOSTION.-E FOAM PIN TYPE TENS ELECT

    FDA 510(k)
    FDA Class 2 ·Neurology

    DIGITAL BLOOD PRESSURE MONITOR

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    FORMULA ONE POWDERED LATEX EXAMINATION GLOVE, WITH PROTEIN CONTENT LABELING CLAIM 200 MICROGRAMS OR LESS AND MADE FROM A

    FDA 510(k)
    FDA Class 1 ·General Hospital

    NUCLEUS 24 CHANNEL COCHLEAR IMPLANT SYSTEM

    FDA Adverse Event
    Injury ·COCHLEAR LTD·Product code MCM·January 9, 2013

    FUSION OMNI-TOME

    FDA Adverse Event
    Malfunction ·WILSON-COOK MEDICAL INC.·Product code KNS·February 11, 2014

    REALIZE ADJ GASTRIC BAND-C

    FDA Adverse Event
    Malfunction ·OBTECH MEDICAL SARL_·Product code LTI·November 18, 2010

    icumedical Oncology Kit w/12" Ext Set w/Spiros w/Red Cap, Clamp, Graduated Adapter; ChemoClave Vented Vial Spike, 20mm; ChemoClave Vented Vial Spike, 13mm; Spiros wRed Cap, REF 3943. Used in IV administration sets. The ChemoCLAVE Cytotoxic Medication Preparation and Delivery System consists of 6 previously cleared components (CLAVE, Spikes, SPIROS, GENIE, Vial Access, and Admin Sets) that can be combined into various configurations intended for use in the preparation and patient administration of cytotoxic medications.

    FDA Enforcement
    Class I ·Terminated·ICU Medical, Inc.·April 24, 2019

    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