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

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    DENTAL OFFICE ENVIRONMENT CONTROL UNIT

    FDA 510(k)
    FDA Class 1 ·Dental

    SafePath Suturing System

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

    SHIMADZU MOBILE X-RAY SYSTEM MOBILEDART EVOLUTION

    FDA 510(k)
    FDA Class 2 ·Radiology

    LAP-BAND ADJUSTABLE GASTRIC BANDING SYSTEM (UNK SIZE)

    FDA Adverse Event
    Injury ·ALLERGAN·Product code LTI·April 21, 2014

    LRG TAP PRI MOD NCK 8DEG 34MM

    FDA Adverse Event
    Injury ·STRYKER ORTHOPAEDICS CORK·Product code MEH·October 4, 2012

    RESERVOIR 1.8ML

    FDA Adverse Event
    Malfunction ·MEDTRONIC PUERTO RICO OPERATIONS CO.·Product code FRN·May 19, 2015

    ALLOFIT ALLOCLASSIC SHELL 58/LL

    FDA Adverse Event
    Malfunction ·ZIMMER GMBH·Product code KWB·May 26, 2015

    Brand Name: Alcon Laboratories, Inc. Product Name: Custom Pak Model/Catalog Number: Many - See 'Attachment 1 - Affected Product List' Software Version: N/A Product Description: Alcon Custom Paks are customer-designed sterile surgical procedure packs / convenience kits intended for use by trained ophthalmic surgeons in a variety of ophthalmic surgeries. Custom Pak is a collection of various ophthalmic surgical instruments and the necessary materials necessary to perform an ophthalmic surgical procedure. Component: N/A

    FDA Enforcement
    Class II ·Ongoing·Alcon Research LLC·July 16, 2025