BEUDAMED
    12 results · 20ms · Sources: EU EUDAMED, US FDA

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    ETKON ES1, MODEL 019.0001, ETKON VISUAL, STRAUMANN CADCAM ABUTMENT

    FDA 510(k)
    FDA Class 2 ·Dental

    APEX Knee System

    FDA UDI
    Omni Life Science, Inc.·00841690198109·AK3 PS Insert Trial Size 1, 13mm

    MODIFICATION TO NANMA VACUUM PUMP

    FDA 510(k)
    FDA Class 2 ·Gastroenterology, Urology

    KSEA SCB-RUI SCO

    FDA 510(k)
    FDA Class 2 ·Gastroenterology, Urology

    OT ULTRALINK METER

    FDA Adverse Event
    Malfunction ·LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL·Product code NBW·May 3, 2013

    ADULT CPB CUSTOM PACK

    FDA Adverse Event
    Malfunction ·DATASCOPE CORP·Product code DWF·August 21, 2014

    9800

    FDA Adverse Event
    Malfunction ·GE OEC MEDICAL SYSTEMS (SLC)·Product code JAA·May 3, 2011

    T-PIECE NEONATAL PATIENT CIRCUIT KIT, DISPOSABLE, WITH SIZE

    FDA Adverse Event
    Injury ·MERCURY MEDICAL·Product code CAI·September 29, 2015

    NEONATAL PATIENT CIRCUIT KIT

    FDA Adverse Event
    Injury ·MERCURY MEDICAL·Product code CAI·September 21, 2015

    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

    Promote Quadra, Sterile EO, Model # / Part #: CD3221-36/100025054, 60019195; CD3223-36P/100013763; CD3239-40/100029115, 100029254, 100037181; CD3239-40Q/100029116, 100029244, 100037115

    FDA Enforcement
    Class II ·Terminated·St Jude Medical Inc.·July 4, 2018

    Product Name: Alcon Custom Pak Model/Catalog Number: Many Software Version: N/A Product Description: Alcon Custom Paks are customer-designed sterile surgical procedure packs / convenience kits intended for use by trained ophthalmic surgeons in a variety of ophthalmic surgeries. Custom Pak is a collection of various ophthalmic surgical instruments and the necessary materials necessary to perform an ophthalmic surgical procedure. Component: N/A

    FDA Enforcement
    Class II ·Ongoing·Alcon Research LLC·August 28, 2024