BEUDAMED
    11 results · 21ms · Sources: EU EUDAMED, US FDA

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    BLASTOMERE BIOPSY PIPETTES, POLAR BODY BIOPSY PIPETTES

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

    MONITORR ICP EXTERNAL CSF DRAINAGE AND MONITORING SYSTEM

    FDA 510(k)
    FDA Class 2 ·Neurology

    REMSTAR AUTO CPAP SYSTEM

    FDA 510(k)
    FDA Class 2 ·Anesthesiology

    EDWARDS ESHEATH INTRODUCER SET

    FDA Adverse Event
    Injury ·EDWARDS LIFESCIENCES·Product code NPT·December 6, 2021

    EDWARDS TF SHEATH UNKNOWN

    FDA Adverse Event
    Injury ·EDWARDS LIFESCIENCES·Product code NPT·October 30, 2021

    DISTAL TARGETING DEVICE GAMMA3 DISTAL TARGETING R1.5

    FDA Adverse Event
    Malfunction ·STRYKER OSTEOSYNTHESIS-KIEL·Product code LXH·May 3, 2013

    TRAPEZOID? RX

    FDA Adverse Event
    Malfunction ·BOSTON SCIENTIFIC - SPENCER·Product code LQC·September 16, 2014

    GREENLIGHT ADDSTAT

    FDA Adverse Event
    Malfunction ·AMERICAN MEDICAL SYSTEMS, INNOVATION CENTER - SILICON VALLEY·Product code GEX·May 2, 2011

    Belmont Rapid Infuser, a Fluid Management System, Model FMS2000.

    FDA Enforcement
    Class II ·Terminated·Belmont Instrument Corporation·October 24, 2012

    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

    Alaris Syringe Pump, Model No. 8110. Delivers fluids. Expansion of Affected Units: BOM Housing Assembly Service, Part No. 49000226, and Lower Housing/Carriage Block Assembly, Part No. 148188-100.

    FDA Enforcement
    Class I ·Terminated·CareFusion 303, Inc.·August 26, 2015