BEUDAMED
    20 results · 21ms · Sources: EU EUDAMED, US FDA

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    ULTRACELL ABSORBENT STICK

    FDA 510(k)
    FDA Class 2 ·Ophthalmic

    Henry Schein

    FDA UDI
    HENRY SCHEIN, INC.·00304040019061·Zirlux 16+ 20x19x15 B2

    N/A

    FDA UDI
    GE MEDICAL SYSTEMS INFORMATION TECHNOLOGIES, INC.·00840682105217·CONFIG CABLE ASSY UNITY NTWK ID TO DASH

    LYPHOCHEK FERTILITY CONTROL, MODELS 480, 481, 482, 483

    FDA 510(k)
    FDA Class 1 ·Clinical Chemistry

    TOTAL CURE

    FDA 510(k)
    FDA Class 2 ·Dental

    KINETRA

    FDA Adverse Event
    Injury ·MEDTRONIC MED REL MEDTRONIC PUERTO RICO·Product code MHY·July 20, 2015

    ULTRACISION SURG DEV, BLADES 5MM, OPEN

    FDA Adverse Event
    Malfunction ·ETHICON ENDO-SURGERY, INC.(CINCINNATI)·Product code LFL·June 15, 2006

    ULTRACISION SURG DEV, BLADES 5MM, OPEN

    FDA Adverse Event
    Malfunction ·ETHICON ENDO SURGERY, INC.(CINCINNATI)·Product code LFL·June 19, 2006

    FREESTYLE FLASH

    FDA Adverse Event
    Malfunction ·ABBOTT DIABETES CARE INC.·Product code LFR·May 16, 2007

    OCTRODE

    FDA Adverse Event
    Injury ·ST. JUDE MEDICAL - NEUROMODULATION·Product code GZB·March 13, 2013

    HEARTSTRING III PROXIMAL SEAL SYSTEM, 3.8 MM

    FDA Adverse Event
    Malfunction ·MAQUET CARDIOVASCULAR, LLC·Product code DXC·February 1, 2011

    ACTIVA

    FDA Adverse Event
    Malfunction ·MEDTRONIC MED REL MEDTRONIC PUERTO RICO·Product code MHY·August 9, 2016

    ITREL II

    FDA Adverse Event
    Injury ·MDT PUERTO RICO OPERATIONS CO·Product code MHY·January 17, 2012

    KINETRA

    FDA Adverse Event
    Injury ·MEDTRONIC MED REL MEDTRONIC PUERTO RICO·Product code MHY·June 4, 2013

    SOLETRA

    FDA Adverse Event
    Injury ·MEDTRONIC MED REL MEDTRONIC PUERTO RICO·Product code MHY·November 13, 2020

    ACTIVA

    FDA Adverse Event
    Injury ·MEDTRONIC MED REL MEDTRONIC PUERTO RICO·Product code MHY·November 13, 2020

    UNKNOWN

    FDA Adverse Event
    Malfunction ·COOK INC·Product code BWC·September 4, 2019

    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

    Exactech Equinoxe REVERSE SHOULDER,42mm Humeral Liner, a) +0mm, Item number 320-42-00, b) +2.5mm, Item Number 320-42-03; Shoulder Arthroplasty

    FDA Enforcement
    Class II ·Ongoing·Exactech, Inc.·April 10, 2024

    Unify Assura, Sterile EO, Model #/ Part #: CD3257-40/100042333, 100059944; CD3257-40Q/100042334, 100059936; CD3261-40/100048460, 100048546, 100059897, 100059954, 100059996, 100078828; CD3261-40Q/100048568, 100048581, 100059898, 100059955, 100059997, 100078853; CD3357-40C/100080408, 100080424, 100083511; CD3357-40Q/100080419, 100080463, 100083504; CD3361-40/100078842, 100079211, 100083506, 100096893; CD3361-40C/100078604, 100079159, 100079160, 100079338, 100083429, 100083514, 100117625; CD3361-40Q/100078805, 100079222, 100079456, 100083523, 100098067; CD3361-40QC/100078654, 100079202, 100079221, 100083475, 100083515, 100117558; CD3389-40C/100080778; CD3389-40QC/100080780, 100105489

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