BEUDAMED
    15 results · 26ms · Sources: EU EUDAMED, US FDA

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    RAINBOW ADHESIVE CO-OXIMETRY SENSOR, MODELS RI-25-L, RI-25, RI-20 AND RI-20-L

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    RAINBOW R1 25L SENSOR

    FDA Adverse Event
    Malfunction ·MASIMO CORPORATION·Product code DQA·June 19, 2015

    GPW-SF

    FDA 510(k)
    FDA Class 2 ·Dental

    PRE-POWDERED LATEX EXAMINATION GLOVES WITH PROTEIN LABELING CLAIM (180 UG/OR LESS)

    FDA 510(k)
    FDA Class 1 ·General Hospital

    AEQUALIS REVERSED CEMENTLESS METAPHYSIS HA D.36MM

    FDA Adverse Event
    Injury ·TORNIER S.A.S.·Product code KWS·May 30, 2023

    PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP

    FDA Adverse Event
    Injury ·MEDTRONIC PUERTO RICO OPERATIONS CO.·Product code OYC·April 29, 2013

    COLLEAGUE PRE P1.7

    FDA Adverse Event
    Malfunction ·BAXTER HEALTHCARE - SINGAPORE·Product code FRN·May 9, 2011

    HOVEROUND CORPORATION

    FDA Adverse Event
    Injury ·HOVEROUND CORPORATION·Product code ITI·July 23, 2008

    INFINION 16

    FDA Adverse Event
    Injury ·BOSTON SCIENTIFIC NEUROMODULATION·Product code LGW·July 8, 2024

    Ankle Arthrodesis Nail, right T2 Ankle ¿11x300mm, Product Number 18191130S

    FDA Enforcement
    Class II ·Terminated·Stryker GmbH·July 18, 2018

    Femoral Nail, LEFT T2 GTN ¿12x360 mm, Product Number 18501236S

    FDA Enforcement
    Class II ·Terminated·Stryker GmbH·July 18, 2018

    Femoral Nail, A/R T2 Femur ¿12x360 mm, Product Number 18251236S

    FDA Enforcement
    Class II ·Terminated·Stryker GmbH·July 18, 2018

    AEQUALIS REVERSED GLENOSPHERE 10 DEGREES TILTED 36 MM X 25MM

    FDA Adverse Event
    Injury ·TORNIER S.A.S.·Product code KWS·April 25, 2022

    AEQUALIS REVERSED CEMENTLESS METAPHYSIS HA D.36MM

    FDA Adverse Event
    Injury ·TORNIER S.A.S.·Product code KWS·April 20, 2023

    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