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

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    TRACOE Cuff Pressure Monitor

    FDA 510(k)
    FDA Class 2 ·Anesthesiology

    KMEDIC

    FDA UDI
    TELEFLEX INCORPORATED·24026704284942·GELPI RETRACTOR 4 1/2" SHARP POINTS

    KMEDIC

    FDA UDI
    TELEFLEX INCORPORATED·14026704921062·

    CELLAVISION DM1200 WITH THE BODY FLUID APPLICTION

    FDA 510(k)
    FDA Class 2 ·Hematology

    THERMAGE THERMACOOL SKIN MARKETING

    FDA 510(k)
    FDA Class 2 ·General, Plastic Surgery

    POLYFORM? SYNTHETIC MESH

    FDA Adverse Event
    Injury ·BOSTON SCIENTIFIC - MARLBOROUGH·Product code OTO·October 8, 2014

    PROLIFT PELVIC FLOOR REPAIR

    FDA Adverse Event
    Injury ·ETHICON, INC.·Product code OTP·June 8, 2013

    ACS HI-TORQUE BALANCE MIDDLEWEIGHT GUIDE WIRE WITH HYDROCOAT HYDROPHILIC COATI

    FDA Adverse Event
    Malfunction ·AV-TEMECULA-CT·Product code DQX·July 7, 2011

    UNKNOWN

    FDA Adverse Event
    Injury ·COOK INC·Product code KRD·November 6, 2020

    UNKNOWN

    FDA Adverse Event
    Injury ·COOK INC·Product code KRD·November 6, 2020

    UNKNOWN

    FDA Adverse Event
    Injury ·COOK INC·Product code KRD·November 6, 2020

    NESTER PLATINUM EMBOLIZATION COIL

    FDA Adverse Event
    Injury ·COOK INC·Product code KRD·June 14, 2020

    NESTER PLATINUM EMBOLIZATION COIL

    FDA Adverse Event
    Injury ·COOK INC·Product code KRD·February 19, 2020

    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

    GXL acetabular liners, orthopedic hip implant component. Product Line Numbers: a. NOVATION CONSTRAINED LINER 28MM ID GROUP 1, REF 134-28-41 b. NOVATION CONSTRAINED LINER 32MM ID GROUP 2, REF 134-32-42 c. NOVATION CONSTRAINED LINER 36MM ID GROUP 3, REF 134-36-43 d. NOVATION CONSTRAINED LINER 36MM ID GROUP 4, REF 134-36-44 e. NOVATION CONSTRAINED LINER 36MM ID GROUP 5, REF 134-36-45

    FDA Enforcement
    Class II ·Ongoing·Exactech, Inc.·September 21, 2022