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

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    8MP Color LCD Monitor, RadiForce RX850, RX850-AR

    FDA 510(k)
    FDA Class 2 ·Radiology

    MODEL 3300E/ER MONOPLACE HYPERBARIC OXYGEN CHAMBER

    FDA 510(k)
    FDA Class 2 ·Anesthesiology

    TIGER FLAT SURGICAL MASK

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

    BD VACUTAINER® URINE COLLECTION CUP

    FDA Adverse Event
    Malfunction ·BECTON, DICKINSON AND COMPANY (BD)·Product code KDT·February 24, 2022

    PORTABLE OXYGEN GENERATOR (CONCENTRATOR, HOMEFILL)

    FDA Adverse Event
    Malfunction ·INVACARE FLORIDA OPERATIONS·Product code CAW·October 8, 2014

    CAPSUREFIX NOVUS MRI

    FDA Adverse Event
    Injury ·MPRI·Product code NVN·June 7, 2013

    9900

    FDA Adverse Event
    Malfunction ·GE OEC MEDICAL SYSTEMS (SLC)·Product code JAA·June 24, 2011

    D902 LILLIPUT ECMO M PHISIO

    FDA Adverse Event
    Malfunction ·SORIN GROUP ITALIA SRL·Product code DTZ·April 7, 2022

    LILLIPUP PMP, LILLIPUT PMP INTEGRATED

    FDA Adverse Event
    Malfunction ·SORIN GROUP ITALIA SRL·Product code DTZ·June 27, 2022

    BLUNT TIP SCREW, ÿ 4X34MM

    FDA Adverse Event
    Injury ·ZIMMER GMBH·Product code HSB·June 9, 2025

    BLUNT TIP SCREW, ÿ 4X34MM

    FDA Adverse Event
    Injury ·ZIMMER GMBH·Product code HSB·June 9, 2025

    PROXIMAL HUMERUS, LEFT, LONG, ÿ 7X220MM

    FDA Adverse Event
    Injury ·ZIMMER GMBH·Product code HSB·June 9, 2025

    CORTICAL BONE SCREW, ÿ 4X20MM

    FDA Adverse Event
    Injury ·ZIMMER GMBH·Product code HSB·June 9, 2025

    PROXIMAL HUMERUS NAIL CAP, 0MM

    FDA Adverse Event
    Injury ·ZIMMER GMBH·Product code HSB·June 9, 2025

    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

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

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

    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