BEUDAMED
    10 results · 31ms · Sources: EU EUDAMED, US FDA

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    VIDISTAR PACS & DICOM VIEWER SOFTWARE SERVER SOFTWARE SYSTEM, HEART VIEW, STANDALONE VIEWER

    FDA 510(k)
    FDA Class 2 ·Radiology

    NEXGEN COMPLETE KNEE SOLUTION CROSS-LINKED POLYETHYLENE CRUCIATE RETAINING (CR) ARTICULAR SURFACE COMPONENTS

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    STERILE PATIENT POWDERFREE LATEX EXAMINATION GLOVES

    FDA 510(k)
    FDA Class 1 ·General Hospital

    LUX 1440

    FDA Adverse Event
    Malfunction ·PALOMAR MEDICAL TECHNOLOGIES, INC.·Product code GEX·May 5, 2012

    INFINION? CX

    FDA Adverse Event
    Injury ·BOSTON SCIENTIFIC NEUROMODULATION CORPORATION·Product code LGW·June 5, 2023

    OT VERIO IQ METER

    FDA Adverse Event
    Malfunction ·LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL·Product code NBW·April 29, 2013

    MARYLAND BIPOLAR FORCEPS INSTRUMENT

    FDA Adverse Event
    Injury ·INTUITIVE SURGICAL,INC.·Product code NAY·May 11, 2011

    ACCU-CHEK AVIVA TEST STRIPS

    FDA Adverse Event
    Malfunction ·ROCHE DIAGNOSTICS·Product code LFR·July 28, 2008

    PORTEX Bivona Tracheostomy Silicone Tube, labeled as: a) 3.0MM FLEXTEND PEDIATRIC STANDARD STRAIGHT TRACH TUBE , Product Code/List Number/Item Code 60PFSS30; b) 3.5MM FLEXTEND PEDIATRIC STANDARD STRAIGHT TRACH TUBE , Product Code/List Number/Item Code 60PFSS35; c) 4.0MM FLEXTEND PEDIATRIC STANDARD STRAIGHT TRACH TUBE TRACH TUBE , Product Code/List Number/Item Code 60PFSS40; d) 4.5MM FLEXTEND PEDIATRIC STANDARD STRAIGHT TRACH TUBE , Product Code/List Number/Item Code 60PFSS45; e) 5.0MM FLEXTEND PEDIATRIC STANDARD STRAIGHT TRACH TUBE , Product Code/List Number/Item Code 60PFSS50; f) 5.5MM FLEXTEND PEDIATRIC STANDARD STRAIGHT TRACH TUBE , Product Code/List Number/Item Code 60PFSS55

    FDA Enforcement
    Class I ·Ongoing·Smiths Medical ASD Inc.·September 4, 2024

    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