BEUDAMED
    217 results · 38ms · Sources: EU EUDAMED, US FDA

    Get notified when this changes

    We'll email you when new records match this search — new devices, new clearances, certificate changes, or withdrawals.
    Filters Regulation: Us FDA ×

    LiquiBand XL

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

    PROTEXIS LATEX BLUE WITH NEU-THERA POWDER-FREE SURGICAL GLOVES

    FDA 510(k)
    FDA Class 1 ·General, Plastic Surgery

    EMIT (R) TOX SALICYLIC ASSAY, MODEL 7SO19UL, EMIT (R) TOX SALICYLIC ACID CALIBRATORS, MODEL 7S109UL

    FDA 510(k)
    FDA Class 2 ·Clinical Toxicology

    GÜNTHER TULIP VENA CAVA FILTER JUGULAR APPROACH

    FDA Adverse Event
    Malfunction ·WILLIAM COOK EUROPE·Product code DTK·July 12, 2022

    AFFINITY BED

    FDA Adverse Event
    Malfunction ·HILL-ROM RITTER·Product code HDD·October 22, 2008

    AIR DERMATOME HANDPIECE

    FDA Adverse Event
    Malfunction ·ZIMMER, SURGICAL·Product code GFD·August 10, 2011

    MECHANICAL (MANUAL) WHEELCHAIR

    FDA Adverse Event
    Malfunction ·UNKNOWN·Product code IOR·July 8, 2013

    HemoCue¿ Urine Albumin Microcuvettes, 25 Microcuvettes HemoCue AB Angelholm, Sweden The quantitative, rapid, turbidimetric immunoassay of albumin in human urine using a specially designed analyzer, the HemoCue Albumin 201 Analyzer. The system can be used for the quantitative determination of low levels of albumin in urine for the purpose of screening for, diagnosing, monitoring and to supplement the clinical evidence in the treatment of microalbuminuria. The system is designed for testing using spot samples or timed collections. A quantitative result is obtained within 90 seconds. HemoCue Urine Albumin Microcuvettes are for in vitro diagnostic use only. The HemoCue Albumin 201 Analyzer is only to be used with HemoCue Urine Albumin Microcuvettes

    FDA Enforcement
    Class II ·Terminated·HemoCue AB·November 6, 2013

    AVID TruCustom PACEMAKER PACK (CARDIOLOGY) convenience kits, Item Code: VAMK016

    FDA Enforcement
    Class II ·Terminated·Avid Medical, Inc.·March 7, 2018

    COOK CELECT® PLATINUM NAVALIGN FEMORAL VENA CAVA FILTER SET

    FDA Adverse Event
    Injury ·WILLIAM COOK EUROPE·Product code DTK·May 19, 2022

    GUNTHER TULIP NAVALIGN FEMORAL VENA CAVA FILTER SET

    FDA Adverse Event
    Injury ·WILLIAM COOK EUROPE·Product code DTK·May 19, 2022

    COOK CELECT® PLATINUM NAVALIGN FEMORAL VENA CAVA FILTER SET

    FDA Adverse Event
    Injury ·WILLIAM COOK EUROPE·Product code DTK·May 19, 2022

    COOK CELECT® PLATINUM NAVALIGN FEMORAL VENA CAVA FILTER SET

    FDA Adverse Event
    Injury ·WILLIAM COOK EUROPE·Product code DTK·May 19, 2022

    COOK CELECT® PLATINUM NAVALIGN FEMORAL VENA CAVA FILTER SET

    FDA Adverse Event
    Injury ·WILLIAM COOK EUROPE·Product code DTK·May 19, 2022

    GUNTHER TULIP NAVALIGN FEMORAL VENA CAVA FILTER SET

    FDA Adverse Event
    Injury ·WILLIAM COOK EUROPE·Product code DTK·May 19, 2022

    COOK CELECT® PLATINUM NAVALIGN UNISET VENA CAVA FILTER SET

    FDA Adverse Event
    Injury ·WILLIAM COOK EUROPE·Product code DTK·May 19, 2022

    COOK CELECT® PLATINUM NAVALIGN JUGULAR VENA CAVA FILTER SET

    FDA Adverse Event
    Injury ·WILLIAM COOK EUROPE·Product code DTK·May 19, 2022

    COOK CELECT® PLATINUM NAVALIGN JUGULAR VENA CAVA FILTER SET

    FDA Adverse Event
    Injury ·WILLIAM COOK EUROPE·Product code DTK·May 19, 2022

    GUNTHER TULIP NAVALIGN JUGULAR & FEMORAL VENA CAVA FILTER SET

    FDA Adverse Event
    Injury ·WILLIAM COOK EUROPE·Product code DTK·May 19, 2022

    GUNTHER TULIP NAVALIGN JUGULAR VENA CAVA FILTER SET

    FDA Adverse Event
    Malfunction ·WILLIAM COOK EUROPE·Product code DTK·September 25, 2023