BEUDAMED
    12 results · 28ms · Sources: EU EUDAMED, US FDA

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    DIMENSION VISTA ETHYL ALCOHOL (ALC), ALKALINE PHOSPHATASE (ALP), CALCIUM (CA0 FLEX, LACTIC ACID (LA) FLEX REAGENT CARTRI

    FDA 510(k)
    FDA Class 2 ·Clinical Toxicology

    Puritan Bennett

    FDA UDI
    Covidien LP·10884521078369·700 Series Ventilator,Model 740

    BILAYER MATRIX WOUND DRESSING

    FDA 510(k)
    FDA Unclassified ·Unknown

    NON-CHLORINATED, POLYMER COATED POWDER-FREE NITRILE PATIENT EXAMINATION GLOVES

    FDA 510(k)
    FDA Class 1 ·General Hospital

    CERENOVUS ENTERPRISE

    FDA Adverse Event
    Malfunction ·MEDOS INTERNATIONAL SARL·Product code NJE·November 10, 2025

    ACCU-CHEK ® SPIRIT COMBO

    FDA Adverse Event
    Injury ·ROCHE DIABETES CARE AG·Product code LZG·April 16, 2013

    SYNCHROMED II

    FDA Adverse Event
    Malfunction ·MEDTRONIC NEUROMODULATION·Product code LKK·March 30, 2011

    MONOPOLAR CURVED SCISSORS INSTRUMENT

    FDA Adverse Event
    Malfunction ·INTUITIVE SURGICAL, INC.·Product code GEI·June 13, 2008

    The MTS Set is a single-use, sterile (EO), non-pyrogenic, optional accessory that provides additional connections/disconnections when used with a stay"safe compatible cycler set during acute and chronic PD treatment. The MTS Set utilizes the same PIN engagement technology used in Fresenius stay"safe Patient Connectors (K041792). The MTS Set consists of two (2) stay"safe PIN Connectors at the proximal end, tubing, and a Safe-Lock connector at the distal end. The MTS Set is attached to a cycler set by a patient, care partner, or healthcare professional. The MTS Set is attached during setup to make additional connections to the cycler set when they are prescribed by a physician or when an interruption in treatment is necessary.

    FDA Enforcement
    Class II ·Terminated·Fresenius Medical Care Holdings, Inc.·July 28, 2021

    The MTS Set is a single-use, sterile (EO), non-pyrogenic, optional accessory that provides additional connections/disconnections when used with a stay"safe compatible cycler set during acute and chronic PD treatment. The MTS Set utilizes the same PIN engagement technology used in Fresenius stay"safe Patient Connectors (K041792). The MTS Set consists of two (2) stay"safe PIN Connectors at the proximal end, tubing, and a Safe-Lock connector at the distal end. The MTS Set is attached to a cycler set by a patient, care partner, or healthcare professional. The MTS Set is attached during setup to make additional connections to the cycler set when they are prescribed by a physician or when an interruption in treatment is necessary.

    FDA Recall
    Terminated ·Fresenius Medical Care Holdings, Inc.·Product code KDJ·April 28, 2021

    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

    CADD¿- Solis Ambulatory Infusion Pump, Model 2111 & 2112, Version 1.0, Version 2.0 and Version 3.0 & Model 2120, Version 1.0. Provide measured drug therapy to patients in hospital or outpatient settings.

    FDA Enforcement
    Class II ·Terminated·Smiths Medical ASD, Inc.·June 24, 2015