BEUDAMED
    18 results · 23ms · Sources: EU EUDAMED, US FDA

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    HemosIL HIT-Ab(PF4-H), HemosIL HIT-Ab(PF4-H) Controls

    FDA 510(k)
    FDA Class 2 ·Hematology

    HEMOSIL HIT-AB(PF4-H)

    FDA Adverse Event
    Malfunction ·INSTRUMENTATION LABORATORY CO.·Product code LCO·March 13, 2025

    HEMOSIL HIT-AB(PF4-H)

    FDA Adverse Event
    Malfunction ·INSTRUMENTATION LABORATORY CO.·Product code LCO·March 13, 2025

    HEMOSIL HIT-AB(PF4-H)

    FDA Adverse Event
    Malfunction ·INSTRUMENTATION LABORATORY CO.·Product code LCO·March 13, 2025

    LACTOSORB SYSTEM

    FDA UDI
    BIOMET MICROFIXATION, INC·00841036056117·

    McKesson

    FDA UDI
    MCKESSON MEDICAL-SURGICAL INC.·00612479271609·CLEANER, GERMICIDE PLUS MCKESSON 2.5GL W/SPIGOT...

    VENUS ANTERIOR CERVICAL PLATE

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    ENDOTOOL DRUG DOSE CALCULATOR

    FDA 510(k)
    FDA Class 2 ·Anesthesiology

    FASTTAKE

    FDA Adverse Event
    Malfunction ·LIFESCAN, INC.·Product code CFR·March 26, 2002

    CAPSUREFIX

    FDA Adverse Event
    Injury ·MPRI·Product code NVN·June 8, 2013

    EXTENSION, DUAL 4 CHANNEL 10CM

    FDA Adverse Event
    Injury ·ST. JUDE MEDICAL - NEUROMODULATION·Product code LGW·June 23, 2011

    POLYFLUX LR CAPILLARY DIALZYER

    FDA Adverse Event
    Malfunction ·GAMBRO DIALYSATOREN GMBH·Product code MSF·September 4, 2008

    EVOLUT FX VALVE

    FDA Adverse Event
    Malfunction ·MEDTRONIC MEXICO S. DE R.L. DE CV·Product code NPT·March 10, 2026

    EVOLUT FX VALVE

    FDA Adverse Event
    Malfunction ·MEDTRONIC MEXICO S. DE R.L. DE CV·Product code NPT·March 10, 2026

    OT VERIO IQ METER

    FDA Adverse Event
    Injury ·LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL·Product code NBW·September 24, 2014

    AQUAPAK 340 SW, 340ML W/040 ADAPTOR, INTL. Product Usage: The Humidifier Adaptor is an accessory which allows connection of sterile water or sterile saline to a humidifier circuit for the addition of water vapor to inhalation therapy gases. Only the 040 Humidifier adaptor packaged with the water bottle is affected by this recall.

    FDA Enforcement
    Class II ·Terminated·Teleflex Medical·February 18, 2015

    ELEKTA LIMITED Elekta Synergy Platform, REF MRT 8501, MRT 8511; Medical Charged-Particle Radiation Therapy System Accelerator, Linear

    FDA Enforcement
    Class II ·Ongoing·Elekta, Inc.·December 13, 2023

    Integrity 1.1. Integrity is the interface and control software for the Elekta range of medical digital linear accelerators and is intended to assist a licensed practitioner in the delivery of radiation to defined target volumes.

    FDA Enforcement
    Class II ·Terminated·Elekta, Inc.·April 9, 2014