BEUDAMED
    14 results · 27ms · Sources: EU EUDAMED, US FDA

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    ACUNAV DIAGNOSTIC ULTRASOUND CATHETER 8F AND 10F

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    MEDI

    FDA UDI
    MEDI MANUFACTURING, INC.·04051526780828·LEVAMED ACTIVE ANKLE SUP SLVR R IV

    KMEDIC

    FDA UDI
    TELEFLEX INCORPORATED·24026704293111·

    Bone Screws

    FDA UDI
    ORTHOPEDIATRICS CORP.·00841132134511·3.0/3.5 INSTRUMENT TRAY

    Cosmolock

    FDA UDI
    Kalitec Direct LLC·B07311K0112340·Tap, 6.50mm, Fixed Sleeve

    BIOCURVE SOFT (HIOXIFILCON B) SPHERICAL AND TORIC SOFT CONTACT LENS FOR DAILY WEAR (CLEAR AND BLUE VISIBILITY-HANDLING L

    FDA 510(k)
    FDA Class 2 ·Ophthalmic

    BIOINSULATED SILICONE PUNCTUM PLUG

    FDA 510(k)
    FDA Unclassified ·Unknown

    VITROS 5600 INTEGRATED SYSTEM

    FDA Adverse Event
    Malfunction ·ORTHO-CLINICAL DIAGNOSTICS·Product code JJE·April 22, 2013

    ENDOEYE FLEX DEFLECTABLE VIDEOSCOPE

    FDA Adverse Event
    Injury ·OLYMPUS MEDICAL SYSTEMS CORP·Product code GEI·September 2, 2014

    UNICEL® DXC 600I SYNCHRON ACCESS CLINICAL SYSTEM

    FDA Adverse Event
    Malfunction ·BECKMAN COULTER INC.·Product code JJE·April 27, 2011

    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

    The PRM is intended to be used as part of the ZOOM LATITUDE Programming System to communicate with Boston Scientific implantable pulse generators. The software in use controls all communication functions for the pulse generator.

    FDA Enforcement
    Class II ·Ongoing·Boston Scientific Corporation·September 7, 2022

    The Programmer/Recorder/Monitor (PRM) is intended to be used as part of the ZOOM LATITUDE Programming System to communicate with Boston Scientific implantable pulse generators. The software in use controls all communication functions for the pulse generator.

    FDA Enforcement
    Class II ·Ongoing·Boston Scientific Corporation·September 7, 2022

    The PRM is intended to be used as part of the ZOOM LATITUDE Programming System to communicate with Boston Scientific implantable pulse generators. The software in use controls all communication functions for the pulse generator.

    FDA Enforcement
    Class II ·Ongoing·Boston Scientific Corporation·September 7, 2022