BEUDAMED
    18 results · 21ms · Sources: EU EUDAMED, US FDA

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    CrossFT Knotless Biocomposite Suture Anchor with Disposable Driver

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    NA

    FDA UDI
    Richard Wolf GmbH·04055207048559·INSUFFLATION TUBE SET L 2.7M with integrated h...

    RESTORIS

    FDA UDI
    MAKO SURGICAL CORP.·00848486003463·MCK FEMORAL TRIAL (SIZE 1 LM/RL)

    LEONE SPA

    FDA UDI
    LEONE SPA·08033707018636·CALIBRA 1ST MOLAR BANDS n.LL 1

    Bausch + Lomb

    FDA UDI
    Bausch & Lomb Incorporated·00757770417797·NEEDLE HOUSE

    JEDMED

    FDA UDI
    JEDMED INSTRUMENT COMPANY·M633301705010·NEEDLE HOUSE STRONG LONG CURVE

    MULTIFUNCTIONAL LINEAR PEN

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

    RUIKE 3421 POWERED WHEELCHAIR

    FDA 510(k)
    FDA Class 2 ·Physical Medicine

    V60 VENTILATOR

    FDA Adverse Event
    Malfunction ·RESPIRONICS CALIFORNIA, INC.·Product code MNT·October 14, 2014

    URETEX SUPPORT PP KIT X1

    FDA Adverse Event
    Injury ·SOFRADIM PRODUCTION·Product code OTN·June 12, 2013

    POWERED WHEELCHAIR

    FDA Adverse Event
    Malfunction ·INVACARE SUZHOU·Product code ITI·July 21, 2011

    T-HANDLE INSERTER

    FDA Adverse Event
    Malfunction ·EIT EMERGING IMPLANT TECHNOLOGIES GMBH·Product code MAX·April 29, 2021

    ZILVER PTX DRUG ELUTING PERIPHERAL STENT

    FDA Adverse Event
    Injury ·COOK IRELAND LTD·Product code NIU·October 16, 2019

    KING LAD SILI CONE SINGLE USE, King Systems devices/case, ETO Sterile. Size 2 / Infant Silicone King LAD¿ Patient Size: 10-20kg Product Usage: Laryngeal airway

    FDA Enforcement
    Class II ·Terminated·King Systems Corp.·November 28, 2012

    T-HANDLE

    FDA Adverse Event
    Malfunction ·EIT EMERGING IMPLANT TECHNOLOGIES GMBH·Product code LXH·May 2, 2023

    IMPLANT INSERTER SH CONNECTION

    FDA Adverse Event
    Malfunction ·EIT EMERGING IMPLANT TECHNOLOGIES GMBH·Product code MAX·May 2, 2023

    INTERSTIM

    FDA Adverse Event
    Injury ·MEDTRONIC PUERTO RICO OPERATIONS CO.·Product code EZW·January 20, 2021

    ASPRIRE Cristalle Mammography System (cleared under K212873) installed with the ASPIRE Cristalle Digital Breast Tomosynthesis (DBT) Option (approved under P160031).

    FDA Enforcement
    Class II ·Ongoing·FUJIFILM Healthcare Americas Corporation·August 6, 2025