BEUDAMED
    16 results · 24ms · Sources: EU EUDAMED, US FDA

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    GEBAUER'S INSTANT ICE

    FDA 510(k)
    FDA Unclassified ·Unknown

    BD Q-SYTE¿ MICRO BORE EXTENSION SET

    FDA Adverse Event
    Malfunction ·BD INFUSION THERAPY SYSTEMS INC. S.A. DE C.V.·Product code FPA·September 21, 2021

    MILLENIUM'S SKELITE SYNTHETIC RESORBABLE BONE VOID FILLER

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    PROSAFE SAFETY SYRINGE

    FDA 510(k)
    FDA Class 2 ·General Hospital

    MODIFIED KUGEL PATCH

    FDA Adverse Event
    Injury ·DAVOL INC., SUB. C.R. BARD, INC.·Product code FTL·October 7, 2010

    MODIFIED KUGEL PATCH

    FDA Adverse Event
    Malfunction ·DAVOL INC.·Product code FTL·September 1, 2011

    LOTUS EDGE VALVE SYSTEM

    FDA Adverse Event
    Injury ·BOSTON SCIENTIFIC CORPORATION·Product code NPT·February 16, 2021

    INTERLOCK¿

    FDA Adverse Event
    Injury ·BOSTON SCIENTIFIC - CORK·Product code KRD·March 26, 2013

    MULTI-LINK MINI VISION OTW CORONARY STENT SYSTEM

    FDA Adverse Event
    Injury ·AV-TEMECULA-CT·Product code MAF·March 17, 2011

    GE OEC 9800

    FDA Adverse Event
    Malfunction ·GE OEC MEDICAL SYSTEMS, INC.·Product code JAA·March 19, 2008

    MODIFIED KUGEL PATCH

    FDA Adverse Event
    Injury ·DAVOL INC., SUB. C.R. BARD, INC.·Product code FTL·June 27, 2013

    MODIFIED KUGEL PATCH

    FDA Adverse Event
    Injury ·DAVOL INC., SUB. C.R. BARD, INC.·Product code FTL·May 25, 2016

    BD Q-SYTE¿ EXTENSION SET MICRO BORE

    FDA Adverse Event
    Malfunction ·BD INFUSION THERAPY SYSTEMS INC. S.A. DE C.V.·Product code FPA·November 4, 2021

    MODIFIED KUGEL PATCH

    FDA Adverse Event
    Injury ·DAVOL INC·Product code FTL·August 2, 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

    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