BEUDAMED
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    TENACORE TRANSDUCERS FOR FETAL ULTRASONIC AND TOKODYNAMOMETER MONITORING

    FDA 510(k)
    FDA Class 2 ·Obstetrics/Gynecology

    Extension Cable for SpO2 Sensor,DB9

    FDA UDI
    Shenzhen Mindray Bio-Medical Electronics Co., Ltd.·06944904003832·

    KNIGHTSTAR 330 VENTILATOR

    FDA 510(k)
    FDA Class 2 ·Anesthesiology

    SENSITITRE HAEMOPHILUS/STREPTOCOCCUS PNEUMONIAE (HP) MIC PLATE

    FDA 510(k)
    FDA Class 2 ·Microbiology

    CAIMAN DISP. INSTR. NON ARTICUL. D:5/360MM

    FDA Adverse Event
    Malfunction ·AESCULAP AP & CO. KG·Product code GEI·March 27, 2015

    CAIMAN DISP.INSTR.ARTICULAT.D:12/240MM

    FDA Adverse Event
    Malfunction ·AESCULAP AG & CO KG·Product code GEI·April 6, 2015

    CAIMAN DISP.INSR.ARTICULAT.D:12 / 240MM

    FDA Adverse Event
    Malfunction ·AESCULAP AG& CO. KG·Product code GEI·April 15, 2015

    CAIMAN DISP INSTR ARTICULAT D:12/240MM

    FDA Adverse Event
    Malfunction ·AESCULAP AG & CO KG·Product code GEI·April 16, 2014

    HOMECHOICE AUTOMATED PD SET WITH CASSETTE

    FDA Adverse Event
    Malfunction ·BAXTER HEALTHCARE - MOUNTAIN HOME·Product code FKX·April 9, 2013

    CONSTELLATION WITH LASER

    FDA Adverse Event
    Malfunction ·ALCON - IRVINE TECHNOLOGY CENTER·Product code HQC·March 25, 2011

    ENDOTAK RELIANCE G

    FDA Adverse Event
    Injury ·CARDIAC PACEMAKERS, INC·Product code LWS·May 8, 2008

    CAIMAN DISP. INSTR. ARTICULAT. D.: 12/440MM

    FDA Adverse Event
    Malfunction ·AESCULAP AG & CO. KG·Product code GEI·July 28, 2014

    BD ALARIS SMARTSITE LOW SORBING EXTENSION SET

    FDA Adverse Event
    Malfunction ·SISTEMAS MEDICOS ALARIS S.A. DE C.V.·Product code FPA·January 17, 2024

    BD ALARIS SMARTSITE LOW SORBING EXTENSION SET

    FDA Adverse Event
    Malfunction ·SISTEMAS MEDICOS ALARIS S.A. DE C.V.·Product code FPA·January 17, 2024

    Thoratec HeartMate 3, LVAS Implant Kit, REF:106524INT, Sterile EO, RxOnly

    FDA Enforcement
    Class I ·Ongoing·Thoratec Corp.·May 8, 2024

    Thoratec HeartMate 3, LVAS Implant Kit, REF:106524US, Sterile EO, RxOnly

    FDA Enforcement
    Class I ·Ongoing·Thoratec Corp.·May 8, 2024

    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

    Unify Assura, Sterile EO, Model #/ Part #: CD3257-40/100042333, 100059944; CD3257-40Q/100042334, 100059936; CD3261-40/100048460, 100048546, 100059897, 100059954, 100059996, 100078828; CD3261-40Q/100048568, 100048581, 100059898, 100059955, 100059997, 100078853; CD3357-40C/100080408, 100080424, 100083511; CD3357-40Q/100080419, 100080463, 100083504; CD3361-40/100078842, 100079211, 100083506, 100096893; CD3361-40C/100078604, 100079159, 100079160, 100079338, 100083429, 100083514, 100117625; CD3361-40Q/100078805, 100079222, 100079456, 100083523, 100098067; CD3361-40QC/100078654, 100079202, 100079221, 100083475, 100083515, 100117558; CD3389-40C/100080778; CD3389-40QC/100080780, 100105489

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

    Boston Scientific COGNIS CRT-D, Cardiac Resynchronization Therapy Defibrillator, models N118, N119. The following models are not available in the US: models N106, N107, P106, P107. Sterilized using ethylene oxide. Boston Scientific, 4100 Hamline Avenue North, St. Paul, MN 55112-5798 USA. Indicated for patients who are at risk for sudden cardiac death due to ventricular arrhythmias and may require pacing support.

    FDA Enforcement
    Class II ·Terminated·Boston Scientific CRM Corp·October 23, 2013