BEUDAMED
    11 results · 28ms · Sources: EU EUDAMED, US FDA

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    MODIFICATION TO: POLARCATH PERIPHERAL DILATATION SYSTEM

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    TALOS® IBF

    FDA UDI
    MEDITECH SPINE, LLC·B16740924550·

    TALOS® IBF

    FDA UDI
    MEDITECH SPINE, LLC·B1674092455060·

    SPIFE LD-12 KIT, MODEL 3338

    FDA 510(k)
    FDA Class 2 ·Clinical Chemistry

    WELCH ALLYN DURASHOCK BLOOD PRESSURE SYSTEM

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    DEXCOM FOLLOW APP

    FDA Adverse Event
    Injury ·DEXCOM, INC.·Product code MDS·March 2, 2020

    POLYFORM SYNTHETIC MESH

    FDA Adverse Event
    Injury ·PROXY BIOMEDICAL LTD.·Product code FTL·April 23, 2013

    R SERIES DEFIBRILLATOR

    FDA Adverse Event
    Malfunction ·ZOLL MEDICAL CORPORATION·Product code MKJ·September 5, 2014

    9800

    FDA Adverse Event
    Malfunction ·GE OEC MEDICAL SYSTEMS (SLC)·Product code JAA·May 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

    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