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

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    DIMENSION VISTA ENZYME 1 CALIBRATOR (ENZ 1 CAL - KC310)

    FDA 510(k)
    FDA Class 2 ·Clinical Chemistry

    REGENCY POWER WHEELCHAIR, MODEL 7200, 7500 & 7800

    FDA 510(k)
    FDA Class 2 ·Physical Medicine

    INRATIO SELF-TEST

    FDA 510(k)
    FDA Class 2 ·Hematology

    INRATIO2

    FDA Adverse Event
    Malfunction ·ALERE SAN DIEGO, INC·Product code GJS·August 1, 2011

    BD VACUTAINER® SST¿ BLOOD COLLECTION TUBES

    FDA Adverse Event
    Malfunction ·BECTON, DICKINSON & CO., (BD)·Product code JKA·May 1, 2018

    BD VACUTAINER® SST¿ BLOOD COLLECTION TUBES

    FDA Adverse Event
    Malfunction ·BECTON, DICKINSON & CO., (BD)·Product code JKA·May 3, 2018

    THREE PEG PATELLA 35MM

    FDA Adverse Event
    Injury ·EXACTECH, INC.·Product code JWH·December 28, 2022

    LIFEPAK(R) 20 DEFIBRILLATOR/MONITOR

    FDA Adverse Event
    Malfunction ·PHYSIO-CONTROL, INC·Product code LDD·April 16, 2013

    MPA

    FDA Adverse Event
    Malfunction ·ROCHE DIAGNOSTICS·Product code JJE·June 16, 2008

    REFURBED COLLEAGUE CX VOLUMETRIC INFUSION PUMP SINGLE CHANNE

    FDA Adverse Event
    Malfunction ·BAXTER HEALTHCARE - SINGAPORE·Product code FRN·April 19, 2011

    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

    Quadra Assura, Sterile EO, Model #/ Part #: CD3265-40/100042335, 100059846; CD3265-40Q/100042336, 100059847; CD3267-40/100042956, 100043569, 100059961, 100078810; CD3267-40Q/100043132, 100043539, 100059917, 100059956, 100078904; CD3365-40C/100080435, 100080436; CD3365-40Q/100080426, 100080427; CD3367-40/100078813, 100079497, 100096097; CD3367-40C/100078597, 100079174, 100079450, 100079490, 100105524; CD3367-40Q/100078851, 100079212, 100079504, 100096098; CD3367-40QC/100078656, 100079193, 100079498, 100079524, 100105513, 100105514, 100138185, 100138213; CD3385-40C/100080778; CD3385-40QC/100080780, 100105489

    FDA Enforcement
    Class II ·Terminated·St Jude Medical Inc.·July 4, 2018

    CADD-Solis VIP ambulatory Infusion Pumps, Model 2120 (21-2120, 21-2125, and 21-2127) Indicated for the following uses: Intra-arterial, subcutaneous, intraperitoneal, in close proximity to nerves, into an intraoperative site, epidural space or subarachnoid space. Therapies that require a continuous rate of infusion, intermittent bolus, and/or with patient-controlled demand doses.

    FDA Enforcement
    Class I ·Ongoing·Smiths Medical ASD Inc.·August 14, 2024