BEUDAMED
    13 results · 20ms · Sources: EU EUDAMED, US FDA

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    Mepiseal Soft Silicone Sealant

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

    Ball Joint Driver Short 3.5 ZH

    FDA UDI
    SIGNATURE ORTHOPAEDICS PTY LTD·09348215076382·

    RADIFOCUS GLIDEWIRE M

    FDA Adverse Event
    Injury ·TERUMO CORPORATION, ASHITAKA·Product code DQX·January 22, 2018

    ENTERAL FEEDING BAG AND SETS

    FDA 510(k)
    FDA Class 2 ·Gastroenterology, Urology

    IMPLANTMED SI-915 (115V VERSION); IMPLANTMED SI-923 (230V VERSION) INCL. ACCESSORIES

    FDA 510(k)
    FDA Class 1 ·Dental

    PENUMBRA SYSTEM ACE 64 REPERFUSION CATHETER

    FDA Adverse Event
    Malfunction ·PENUMBRA, INC.·Product code NRY·July 17, 2015

    AXOGUARD NERVE CONNECTOR AND PROTECTOR

    FDA Adverse Event
    Injury ·COOK BIOTECH·Product code JXI·October 24, 2019

    PORTABLE OXYGEN GENERATOR (CONCENTRATOR, HOMEFILL)

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

    TERUMO CDI 100 MONITOR

    FDA Adverse Event
    Malfunction ·TERUMO CARDIOVASCULAR SYSTEM CORP.·Product code DTY·June 24, 2011

    KNEE PROSTHESIS

    FDA Adverse Event
    Injury ·SMITH & NEPHEW, INC.·Product code JWH·October 15, 2015

    iCup DX 8 Panel w/Adulterant, Item No. I-DXA-187-016

    FDA Enforcement
    Class III ·Terminated·Ameditech Inc·December 30, 2015

    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

    RECLAIM DISTAL TAPERED, Angled Distal Stem, various sizes. Taper Protector Sleeve. RECLAIM Revision Hip System Orthopedic Manual Surgical Instrument, used to ensure the locking taper surface of the Distal Stem is protected during proximal preparation.

    FDA Enforcement
    Class II ·Terminated·DePuy Orthopaedics, Inc.·July 30, 2014