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

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    DISPOSABLE QUICK RELEASE PERFUSION ADAP

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    ACUMED

    FDA UDI
    Acumed LLC·10806378100123·ARH Slide-Loc™ Locking Guide +5 mm

    QUART ARTERIAL FILTER WITH BIOLINE COATING

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    MEDILOG EXCEL 2 - HOLTER MANAGEMENT SYSTEM

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    H 105700#TUBING SET

    FDA Adverse Event
    Malfunction ·MAQUET CARDIOPULMONARY AG·Product code DWE·May 5, 2015

    HQV 32902#INTEGRATED ADULT PACK

    FDA Adverse Event
    Malfunction ·MAQUET CARDIOPULMONARY AG·Product code DWE·June 22, 2015

    QUARTET

    FDA Adverse Event
    Injury ·ST. JUDE MEDICAL, INC., CRMD·Product code OJX·May 9, 2014

    35 CM BIPOLAR LEAD

    FDA Adverse Event
    Malfunction ·GREATBATCH MEDICAL·Product code DTB·October 19, 2012

    ONETOUCHPING GLUCOSEMGMTSYSTEM

    FDA Adverse Event
    Malfunction ·ANIMAS CORPORATION·Product code LZG·May 28, 2015

    The Acumed Slide-Loc Anatomic Radial Head System is intended for use by surgeons with orthopedic training. The device is to be implanted by the surgeon in a sterile operating room setting. Implants are provided in sterile packages. The Acumed Anatomic Radial Head Slide-Loc System consists of modular heads and stems with accessories for anatomical replacement of the proximal portion of the radius and restore the natural articulation of the radial head with the radial notch of the ulna and capitellum of the distal humerus. The modular heads and stems are single use implantable devices. Each Acumed Slide-Loc Anatomic Radial Head System Set consists of 76 parts/instruments.

    FDA Enforcement
    Class II ·Terminated·Acumed LLC·June 7, 2017

    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