BEUDAMED
    13 results · 23ms · Sources: EU EUDAMED, US FDA

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    MODIFICATION TO SUMMIT OCCIPITO-CERVICO-THORACIC (OCT) SPINAL SYSTEM

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    POLYGLYCOLIC ACID (PGA), ABSORBABLE SURGICAL SUTURE (USP)

    FDA 510(k)
    FDA Class 2 ·General, Plastic Surgery

    AOS MODULAR FEMORAL NAIL

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    DINAMAP PROCARE SERIES MONITOR

    FDA Adverse Event
    Malfunction ·GE HEALTHCARE·Product code MWI·September 9, 2010

    DINAMAP PROCARE SERIES MONITOR

    FDA Adverse Event
    Malfunction ·GE HEALTHCARE·Product code MHX·September 9, 2010

    TENOR SPINAL SYSTEM

    FDA Adverse Event
    Malfunction ·WARSAW ORTHOPEDIC, INC.·Product code KWP·December 27, 2010

    TENOR SPINAL SYSTEM

    FDA Adverse Event
    Malfunction ·WARSAW ORTHOPEDIC, INC.·Product code KWP·December 27, 2010

    POWERED WHEELCHAIR

    FDA Adverse Event
    Malfunction ·INVACARE TAYLOR STREET·Product code ITI·March 26, 2013

    RESTORE ULTRA

    FDA Adverse Event
    Malfunction ·MDT PUERTO RICO OPERATIONS CO., JUNCOS·Product code LGW·February 28, 2011

    LIBERTE' MONORAIL CORONARY STENT DELIVERY SYSTEM

    FDA Adverse Event
    Malfunction ·BOSTON SCIENTIFIC CORPORATION·Product code MAF·March 26, 2008

    SPACEOAR SYSTEM

    FDA Adverse Event
    Injury ·BOSTON SCIENTIFIC CORPORATION·Product code OVB·May 16, 2023

    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

    The Propaq LT Series monitors. Model numbers 802LTAN, 802LT0N, and 802LTRN. These devices are indicated for ECG, noninvasive blood pressure (NIBP), respiration and SpO2. The most likely locations for patients to be monitored by these devices are hospital general medical-surgical, telemetry, and intermediate care floors, hospital emergency departments, transport, emergency medical services, and other healthcare applications. intended to be used by clinicians and medically qualified personnel for single or multiparameter vital signs monitoring of ambulatory and nonambulatory patients, including neonate, pediatric and adult patients. These devices are indicated for ECG, noninvasive blood pressure (NIBP), respiration and SpO2. The most likely locations for patients to be monitored by these devices are hospital general medicalsurgical, telemetry, and intermediate care floors, hospital emergency departments, transport, emergency medical services, and other healthcare applications. The monitors can be used as stand-alone devices or as devices networked to an Acuity Central Station through wireless communication over a Welch Allyn FlexNet network.

    FDA Enforcement
    Class II ·Terminated·Welch Allyn Protocol, Inc·January 15, 2014