BEUDAMED
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    WiScope Digital Endoscope System

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

    AccuQuest

    FDA UDI
    Bernafon AG·05711584081365·AQ CO5 MNR, 2.4G NFM PB MAC ACCUQ

    PROSIT WOUND TREATMENT DEVICE

    FDA 510(k)
    FDA Unclassified ·Unknown

    TAPERED SCREW-VENT T IMPLANT

    FDA 510(k)
    FDA Class 2 ·Dental

    IMP,TSV,4.7,10,MTX,MG

    FDA Adverse Event
    Injury ·ZIMVIE US CORP LLC·Product code DZE·May 22, 2026

    IMP,TSV,4.7,11.5,MTX,MG

    FDA Adverse Event
    Injury ·ZIMMER DENTAL·Product code DZE·June 12, 2024

    IMP,TSV,4.7,10,MTX,MG

    FDA Adverse Event
    Injury ·ZIMMER DENTAL·Product code DZE·October 28, 2024

    IMP,TSV,4.7,8,MTX,MG

    FDA Adverse Event
    Injury ·ZIMVIE US CORP LLC·Product code DZE·April 22, 2026

    IMP,TSV,6.0,11.5,MTX,MG

    FDA Adverse Event
    Injury ·ZIMMER DENTAL·Product code DZE·May 15, 2025

    IMP,TSV,3.7,8,MTX,MG

    FDA Adverse Event
    Injury ·ZIMMER DENTAL·Product code DZE·July 12, 2024

    IMP,TSV,4.7,10,MTX,MG

    FDA Adverse Event
    Injury ·ZIMMER DENTAL·Product code DZE·June 10, 2024

    RESTORE ULTRA

    FDA Adverse Event
    Malfunction ·MEDTRONIC MED REL MEDTRONIC PUERTO RICO·Product code LGW·June 21, 2013

    NUCLEUS 24 CHANNEL COCHLEAR IMPLANT SYSTEM

    FDA Adverse Event
    Malfunction ·COCHLEAR LTD.·Product code MCM·July 28, 2011

    SECONDARY OMNI FLOW SET 40

    FDA Adverse Event
    Malfunction ·HOSPIRA LTD.·Product code FPA·September 22, 2008

    IMP,TSV,4.7,11.5,MTX,MG

    FDA Adverse Event
    Injury ·ZIMMER DENTAL·Product code DZE·November 6, 2024

    IMP,TSV,4.7,8,MTX,MG

    FDA Adverse Event
    Injury ·ZIMMER DENTAL·Product code DZE·November 8, 2024

    IMPL TAPERED SCR-V SBM 3. 7MM 3.5MM 8MM

    FDA Adverse Event
    Injury ·ZIMMER DENTAL·Product code DZE·October 4, 2023

    MAGNETOM Skyra (DE). Model Number: 10432915. 510(k) Numbers: K101347, K111242, K123510, K133435, K140253, K141977, K142515, K153343, K173592, K202014, K231560.

    FDA Recall
    Open, Classified ·Siemens Medical Solutions USA, Inc·Product code LNH·August 28, 2025

    MAGNETOM Skyra (DE). Model Number: 10432915. 510(k) Numbers: K101347, K111242, K123510, K133435, K140253, K141977, K142515, K153343, K173592, K202014, K231560.

    FDA Enforcement
    Class I ·Ongoing·Siemens Medical Solutions USA, Inc·October 8, 2025

    INVICTUS SPINAL FIXATION SYSTEM

    FDA Adverse Event
    Injury ·ALPHATEC SPINE, INC.·Product code NKB·April 30, 2025