BEUDAMED
    12 results · 21ms · 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 ×

    DenTek Fresh Protect Dental Guard

    FDA 510(k)
    FDA Unclassified ·Unknown

    Corneal Trephine

    FDA UDI
    KATENA PRODUCTS, INC.·00841668112595·BARRON CORNEAL PUNCH 7.0MM

    UMBILI-CATH

    FDA Adverse Event
    Malfunction ·UTAH MEDICAL PRODUCTS, INC.·Product code FOS·July 9, 2021

    UMBILI-CATH

    FDA Adverse Event
    Malfunction ·UTAH MEDICAL PRODUCTS, INC.·Product code FOS·July 9, 2021

    EMIT TOX ACETAMINOPHEN ASSAY, MODEL 7A319UL; EMIT TOX ECETAMINOPHEN CALIBRATORS, MODEL 7A409UL

    FDA 510(k)
    FDA Class 2 ·Clinical Toxicology

    MICROHYBRID 12

    FDA 510(k)
    FDA Class 2 ·Dental

    DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM

    FDA Adverse Event
    Malfunction ·DEXCOM, INC.·Product code QBJ·August 13, 2024

    PACEART SYSTEM

    FDA Adverse Event
    Malfunction ·MEDTRONIC, INC.·Product code DPS·August 11, 2011

    HEARTMATE II LVAS

    FDA Adverse Event
    Death ·THORATEC CORP.·Product code DSQ·October 23, 2014

    SYNCHROMED II

    FDA Adverse Event
    Malfunction ·MEDTRONIC NEUROMODULATION·Product code LKK·July 2, 2013

    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

    EMBLEM MRI S-ICD pulse generators, as part of Boston Scientific S-ICD System; Model A219

    FDA Enforcement
    Class II ·Ongoing·Boston Scientific Corporation·February 3, 2021