BEUDAMED
    18 results · 24ms · Sources: EU EUDAMED, US FDA

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    Instant-View Multi-Drug Urine Test Cup (Home Use), Instant-View Multi-Drug Urine Test Panel (Home Use)

    FDA 510(k)
    FDA Class 2 ·Clinical Toxicology

    KMEDIC

    FDA UDI
    TELEFLEX INCORPORATED·24026704283686·

    APEX Revision Knee

    FDA UDI
    Omni Life Science, Inc.·00841690124108·Modular Offset Stem 11mm x 125mm 2mm

    Simpact Tri-Fin

    FDA UDI
    Life Spine, Inc.·00190837062750·Static Pin Offset Guide, 8mm Implant

    LC Instrument Tray

    FDA UDI
    SIGNATURE ORTHOPAEDICS PTY LTD·09348215039448·

    ENDURANCE

    FDA UDI
    DEPUY ORTHOPAEDICS, INC.·10603295057260·FEMORAL STEM 12/14 TAPER ENDURANCE HIP STEM SIZ...

    BISCO LED

    FDA 510(k)
    FDA Class 2 ·Dental

    SMITH & NEPHEW MILTI-PURPOSE STERILIZATION TRAY MODEL 72202428

    FDA 510(k)
    FDA Class 2 ·General Hospital

    ONE TOUCH ULTRA

    FDA Adverse Event
    Malfunction ·LIFESCAN, INC.·Product code CFR·March 20, 2002

    DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM

    FDA Adverse Event
    Malfunction ·DEXCOM, INC.·Product code QBJ·June 13, 2025

    TRUMETRXGO

    FDA Adverse Event
    Malfunction ·TRIVIDIA HEALTH, INC.·Product code NBW·April 26, 2017

    COLLEAGUE PRE P1.7

    FDA Adverse Event
    Malfunction ·BAXTER HEALTHCARE - SINGAPORE·Product code FRN·July 7, 2011

    PELVICOL ACELLULAR COLLAGEN MATRIX

    FDA Adverse Event
    Injury ·TISSUE SCIENCE LABORATORIES·Product code FTL·May 21, 2013

    DEXTRUS 4135

    FDA Adverse Event
    Injury ·BIOTRONIK SE & CO. KG·Product code NVN·October 8, 2014

    FASTTAKE

    FDA Adverse Event
    Malfunction ·LIFESCAN, INC.·Product code CFR·June 6, 2003

    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

    Exactech Equinoxe REVERSE SHOULDER,46mm Humeral Liner, a) +0mm, Item number 320-46-00, b) +2.5mm, Item Number 320-46-03; Shoulder Arthroplasty

    FDA Enforcement
    Class II ·Ongoing·Exactech, Inc.·April 10, 2024

    Aespire View. This anesthesia gas machine is intended to provide general inhalation anesthesia and ventilatory support to patients and are to be used only by medical professionals trained and qualified in the administration of general anesthesia.

    FDA Enforcement
    Class I ·Ongoing·Datex-Ohmeda, Inc.·October 30, 2024