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

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    HOFFMANN II FOOT RING

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    WMT MODULAR SHOULDER SYSTEM

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    FLEXICAST PRIME

    FDA 510(k)
    FDA Class 2 ·Dental

    LEGION PS OXIN FEM SZ5 LT

    FDA Adverse Event
    Injury ·SMITH & NEPHEW, INC.·Product code JWH·February 5, 2018

    SYNFIX(TM)-LR TRIAL IMPL 12DEGDEPTH 26MM/W 32MM/H 13.5MM

    FDA Adverse Event
    Malfunction ·SYNTHES GMBH·Product code MQP·April 8, 2013

    ENDOTAK RELIANCE G

    FDA Adverse Event
    Malfunction ·CARDIAC PACEMAKERS, INC·Product code LWS·May 8, 2008

    TELIGEN

    FDA Adverse Event
    Malfunction ·GUIDANT CRM CLONMEL IRELAND·Product code LWS·April 6, 2011

    Roche brand Accu-Chek Aviva Care Kit; Catalog number 04528280001. (Distributed within the U.S.)

    FDA Recall
    Terminated ·Roche Diagnostics Corp.·Product code LFR·November 9, 2005

    The Spirit Plus Bed, Model 5600 Spirit Plus /with high rail siderail option

    FDA Enforcement
    Class II ·Terminated·Stryker Medical Division of Stryker Corporation·November 21, 2018

    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

    Boston Scientific COGNIS CRT-D, Cardiac Resynchronization Therapy Defibrillator, models N118, N119. The following models are not available in the US: models N106, N107, P106, P107. Sterilized using ethylene oxide. Boston Scientific, 4100 Hamline Avenue North, St. Paul, MN 55112-5798 USA. Indicated for patients who are at risk for sudden cardiac death due to ventricular arrhythmias and may require pacing support.

    FDA Enforcement
    Class II ·Terminated·Boston Scientific CRM Corp·October 23, 2013