BEUDAMED
    17 results · 22ms · Sources: EU EUDAMED, US FDA

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    IMMULISA ANTI-BETA2 GLYCOPROTEIN I (B2GP1) IGG ELISA

    FDA 510(k)
    FDA Class 2 ·Immunology

    LATITUDE EV™

    FDA UDI
    TORNIER, INC.·00846832074693·Humeral Stem - Coated

    BUSCH®, BNA®

    FDA UDI
    BUSCH & CO. GmbH & Co. KG·D8120307011·Diamond, flame, medium grit

    Kaliec Special

    FDA UDI
    Kalitec Direct LLC·B073DRK0300010·Probe, 1.75" Egg, Steffee Long Str Imp Crimson

    ENDOSKELETON® TT

    FDA UDI
    MEDTRONIC SOFAMOR DANEK, INC.·00191375051275·Lower, Inner Tray

    HUMAN IGG SUBCLASS KIT USE WITH THE BECKMAN IMAGE ANALYZER

    FDA 510(k)
    FDA Class 2 ·Immunology

    SENTECH MEDICAL EXPRESS COMPRESSION SYSTEM (P/N SM800)

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM

    FDA Adverse Event
    Malfunction ·DEXCOM, INC.·Product code QBJ·February 5, 2025

    BD ECLIPSE NEEDLE

    FDA Adverse Event
    Malfunction ·BECTON DICKINSON·Product code FMI·January 17, 2024

    BD ECLIPSE NEEDLE

    FDA Adverse Event
    Malfunction ·BECTON DICKINSON·Product code FMI·January 17, 2024

    BOOMERANG PEEK FUSION DEVICE

    FDA Adverse Event
    Injury ·MEDTRONIC SOFAMOR DANEK·Product code MQP·January 14, 2011

    FORTE EAR CLYLINDER

    FDA Adverse Event
    Malfunction ·STRYKER INSTRUMENTS-KALAMAZOO·Product code NHB·August 14, 2018

    APEX¿

    FDA Adverse Event
    Malfunction ·BOSTON SCIENTIFIC - GALWAY·Product code LOX·April 2, 2013

    ACCU-CHEK FLEXLINK PLUS

    FDA Adverse Event
    Malfunction ·ROCHE INSULIN DELIVERY SYSTEMS INC.·Product code FRN·March 22, 2011

    SMASH BALLOON DILATATION CATHETER

    FDA Adverse Event
    Malfunction ·BOSTON SCIENTIFIC·Product code LIT·April 15, 2008

    MICRO-X ROVER MOBILE X-RAY SYSTEM, MXU-RV19

    FDA Enforcement
    Class II ·Ongoing·Micro-X Ltd.·October 5, 2022

    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